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Environmental Interventions To Reduce The Consumption of Sugar-Sweetened Beverages and Their Effects On Health (Protocol)
Environmental Interventions To Reduce The Consumption of Sugar-Sweetened Beverages and Their Effects On Health (Protocol)
von Philipsborn P, Stratil JM, Burns J, Busert LK, Pfadenhauer LM, Polus S, Holzapfel C, Hauner
H, Rehfuess E
von Philipsborn P, Stratil JM, Burns J, Busert LK, Pfadenhauer LM, Polus S, Holzapfel C, Hauner H, Rehfuess E.
Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health.
Cochrane Database of Systematic Reviews 2016, Issue 7. Art. No.: CD012292.
DOI: 10.1002/14651858.CD012292.
www.cochranelibrary.com
Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health (Protocol)
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Figure 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Figure 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Figure 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Figure 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Figure 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health (Protocol) i
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
[Intervention Protocol]
Peter von Philipsborn1 , Jan M Stratil2 , Jacob Burns3 , Laura K Busert3 , Lisa M Pfadenhauer3 , Stephanie Polus3 , Christina Holzapfel4 ,
Hans Hauner4 , Eva Rehfuess3
1 Faculty
of Medicine, Technical University Munich, 81677 Munich, Germany. 2 Faculty of Medicine, University of Tuebingen, Tue-
bingen, Germany. 3 Institute for Medical Informatics, Biometry and Epidemiology, Ludwig-Maximilians-University Munich, Munich,
Germany. 4 Institute for Nutritional Medicine, Technische Universität München Klinikum rechts der Isar, Munich, Germany
Contact address: Peter von Philipsborn, Faculty of Medicine, Technical University Munich, Stuntzstrasse 12, 81677 Munich, Germany.
peter.philipsborn@alumni.lse.ac.uk.
Citation: von Philipsborn P, Stratil JM, Burns J, Busert LK, Pfadenhauer LM, Polus S, Holzapfel C, Hauner H, Rehfuess E.
Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health. Cochrane Database
of Systematic Reviews 2016, Issue 7. Art. No.: CD012292. DOI: 10.1002/14651858.CD012292.
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
ABSTRACT
This is the protocol for a review and there is no abstract. The objectives are as follows:
To assess the effects of environmental interventions (excluding taxation) targeted at sugar-sweetened beverages or low-calorie alternatives
to sugar-sweetened beverages on consumption levels, diet-related anthropometric measures and health outcomes, and on any reported
unintended consequences or adverse outcomes.
Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health (Protocol) 2
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
SSB constitute a source of empty calories, i.e. they contain energy that provide substantial amounts of nutrients and relatively few
but no micro- and macronutrients except water and sugars. SSB calories, is therefore a key recommendation in a number of na-
consumption can therefore lead to a reduced intake of micro- and tional and international dietary guidelines (Hauner 2012; USDA
macronutrients through alternative beverages as well as through 2015a). More specifically, the Dietary Guidelines for Americans
solid foods, even under conditions of incomplete caloric compen- 2010 recommend to limit intake of SSB and to increase intake
sation (Vartanian 2007). It is estimated that 6.6% (95% CI: 4.7% of unsweetened low-fat or fat-free milk (USDA 2015a), while the
to 8.4%) of the global burden of disease can be attributed to diets World Health Organization (WHO) guideline on dietary sugars
low in fruits, vegetables, fibre, milk and calcium (IHME 2015; strongly recommends to reduce the intake of free sugars (includ-
Lim 2012). To achieve healthy dietary patterns, nutrient needs ing sugars from SSB) throughout the life-course (WHO 2015).
must be met without exceeding energy needs (USDA 2015a). Re- Potentials causal pathways between SSB consumption and adverse
ducing intake of energy-dense but nutrient-poor foods and bev- health outcomes are shown in Figure 1.
erages, such as SSB, and replacing them with foods and beverages
Figure 1. Physiological and psychological mechanisms linking SSB intake with adverse health outcomes.
Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health (Protocol) 3
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
for which intake is lower than recommended among many popu- balance. Consequently, current dietary guidelines recommend to
lations, including calcium, vitamin D and potassium (AAP 2015; limit intake of 100% fruit juice among children and adolescents to
Johnson 2002). For the purpose of this review, and following the moderate amounts, particularly among those who are overweight
Scientific Report of the 2015 U.S. Dietary Guidelines Advisory and obese, and to replace full-fat milk with low-fat or fat-free
Committee, we consider fortified soy beverages, but not almond milk (USDA 2015a). Moreover, full-fat milk is relatively high in
or other plant-based “milk-type” products as a substitute for milk saturated fat (USDA 2015). By contrast, beverages prepared by
(USDA 2015; USDA 2015a). Furthermore, tea and coffee are rec- adding varying amounts of 100% fruit juice to carbonated or
ommended by the Dietary Guidelines for Americans 2015-2020 uncarbonated water without adding additional caloric sweeteners
as alternatives to SSB for the general public (USDA 2015a), but are generally considered acceptable alternatives to SSB (AAP 2015;
caffeine intake from coffee, tea and other sources should be limited DGE 2015).
to moderate amounts among children, adolescents and women Sugar-sweetend milk constitutes another grey area. While dietary
who are pregnant or considering pregnancy (USDA 2015). guidelines generally recommend to choose unsweetened milk (
Beverages containing non-nutritive sweeteners (NNS) are not gen- USDA 2015a), it remains controversial whether sugar-sweetened
erally recommended by dietary guidelines as preferred alternatives milk should be targeted in public health interventions or not (AAP
to SSB (USDA 2015a; USDA 2015). NNS, also known as low- 2015). It has been argued that limits on the consumption of sugar-
calorie, low-energy or artificial sweeteners, are chemically diverse sweetened milk could decrease overall milk intake, and thus overall
compounds with no or minimal caloric content and a sweet taste dietary quality (AAP 2015; Hanks 2014; Johnson 2002). We will
of varying intensity (Fitch 2012). In cross-sectional and cohort therefore consider interventions targeting sugar-sweetened milk
studies frequent consumption of beverages with NNS was asso- as a separate category. A table with all beverage categories to be
ciated with adverse health outcomes similar to those associated considered in this review, and relevant definitions, is provided in
with SSB, including an increased risk of obesity and type 2 dia- Appendix 3.
betes (Imamura 2015; Fowler 2008). However, most RCTs directly
comparing beverages sweetened exclusively with NNS with SSB
have shown results favouring the former with regard to weight gain Sugar-sweetened beverage consumption patterns
(Bellisle 2015; Miller 2014). Moreover, available prospective stud- SSB consumption varies considerably by geographic location, gen-
ies indicate that after adjustment for possible confounders con- der, age and socio-economic status. Based on a systematic review
sumption of beverages with NNS is associated with a lower risk of and pooled analysis of dietary surveys, global mean adult daily SSB
diabetes than consumption of equal amounts of SSB (Greenwood consumption was estimated at 137 mL (95% CI: 88 mL to 211
2014). Furthermore, safety reviews by regulatory and scientific mL) in 2010 (Singh 2015). Mean daily SSB consumption is higher
bodies have generally found NNS to be safe at the levels consumed in upper-middle income countries (189 mL) and lower-middle
by most populations (Fitch 2012; USDA 2015). income countries (140 mL) than in high-income (121 mL) and
Full-fat milk and 100% fruit juice are both relevant sources of low-income (83 mL) countries, with substantial variation within
essential nutrients and relatively energy-dense. Excessive amounts regions (see Figure 2) (Singh 2015). Consumption is generally
of these beverages can therefore contribute to a positive energy higher in younger age groups, among males, and in the Americas
as compared to other world regions (Singh 2015).
Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health (Protocol) 4
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Figure 2. Estimated SSB consumption by country in 2010 (an 8 oz. serving is equivalent to approximately
237 ml). Reproduced with permission from Singh 2015.
Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health (Protocol) 5
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
view, we will classify interventions as environmental when they municipalities. Alternative terms include jurisdiction-based or
aim to alter the food and beverage environment in a permanent macro-level interventions.
way. Interventions that alter the food and beverage environment • Setting-based interventions, which are adopted and
temporarily with the aim of influencing individual preferences implemented within individual settings, such as schools, work
(e.g. a one-off public media campaign) will be considered as be- sites, local retail, food service or recreational facilities. Synonyms
havioural interventions. are community interventions, or meso-level interventions.
In the present review, behavioural interventions will only be con-
sidered when they are part of larger interventions that also in- Some interventions may be implemented either within individual
clude environmental components, as a separate systematic review settings or on a policy level, or they may even target both levels
specifically on behavioural interventions is ongoing (PROSPERO at the same time. Examples include bans on the sale of SSB at
2014a). In addition, we will exclude taxation, as a systematic re- schools, which may be mandated by a local school director for
view and meta analysis on SSB taxes has been published (Cabrera his or her individual school, or by national legislation as part of
Escobar 2013), and another one is ongoing (Cochrane 2015a). a national school nutrition policy. Similarly, interventions such as
To categorise included studies by intervention area we will use labelling or content disclosure requirements are often first evalu-
the NOURISHING framework, which has been developed by the ated by trials within specific settings, e.g. an individual shop or
World Cancer Research Fund International to classify nutrition restaurant, before they are implemented on a policy level, e.g. as
interventions (WCRFI 2015). It is consistent with the interven- part of national regulation. Such pilot trials can help to identify
tion categories used in the WHO Global Action Plan for the Pre- intervention options worth scaling up, and thus provide valuable
vention and Control of Non-Communicable Diseases 2013-2020 information for policymakers. However, scaling up interventions
(WHO 2013) and the INFORMAS food environment bench- which have proven successful within individual settings to the pol-
marking network (INFORMAS 2015). It distinguishes seven en- icy level poses specific challenges. Evaluations of interventions im-
vironmental and policy intervention areas (including the food sys- plemented within individual settings therefore provide only indi-
tem): rect and limited evidence on whether the intervention will or will
• Labelling and food claim rules. not work on a policy level. In the present review, we will there-
• Interventions changing the availability of different foods fore classify interventions only as policy level when they are im-
and beverages in public institutions and other settings. plemented on the level of a geographically-defined political or ad-
• Pricing interventions (including both fiscal and non-fiscal ministrative unit, and when the original studies reporting on them
interventions altering the absolute and relative prices of SSB or evaluate their effects on the same level (e.g. by analysing the effects
low-calorie alternatives to SSB; in the present review, we will of a national school nutrition policy on the SSB consumption of
exclude fiscal interventions, as they are covered by a separate school children in that country). All other interventions, includ-
review). ing pilot trials and evaluations restricted to individual settings will
• Advertisement regulation. be classified as setting-based interventions, regardless of whether
• Reformulation. the intervention in question is suitable for implementation on a
• Changes to the beverage retail and food service policy level or not.
environment.
• Food system approaches (including health-in-all policies
approaches in sectors such as agriculture and trade).
How the intervention might work
In addition, the NOURISHING framework distinguishes three
All environmental nutrition interventions ultimately aim to
behavioural intervention areas:
change human food and beverage intake by providing conductive
• Information on food and nutrition.
environments at different levels. A theoretical framework com-
• Nutrition counselling in health-care settings.
monly used to conceptualise the effects of such interventions is the
• Nutrition education and skills building.
social-ecological model. It postulates that dietary behaviour is in-
Appendix 4 presents the NOURISHING framework in more de- fluenced by a host of individual and environmental factors, which
tail, as well as relevant examples for interventions targeted at SSB can interact to create complex, multi-layered systems (see Figure
or low-calorie alternatives to SSB identified in a scoping literature 3) (CDC 2015; Moodley 2015; Sacks 2009; Swinburn 1999;
search. Swinburn 2011). Environmental interventions generally target the
Moreover, interventions can be classified by their level of imple- macro- and meso-level, i.e. policies and settings. Behavioural in-
mentation (CDC 2015): terventions generally target the micro-level, i.e. interpersonal fac-
• Policy interventions, which are adopted and implemented tors such as social norms and networks of social support, and in-
on the level of geographically-defined political or administrative trapersonal factors such as personal preferences, attitudes and skills
units, such as supra-national organisations, states, regions or (see Figure 3).
Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health (Protocol) 6
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Figure 3. Socio-ecological model of food and beverage intake. Adapted from CDC 2015.
Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health (Protocol) 7
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Figure 4. Determinants of diet-related health outcomes and related interventions. Adapted from Swinburn
2011.
Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health (Protocol) 8
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Figure 5. System-based logic model for the influence of environmental interventions to reduce SSB intake
on beverage choices and diet-related health and non-health outcomes.
Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health (Protocol) 9
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
2015). Finally, policy interventions in particular can have reper- published or registered yet.
cussions on the society and economy as a whole, including vary- Numerous global, regional and national policy initiatives in
ing effects on employment and resource use in different sectors the field of nutrition and health call for action to reduce in-
(Powell 2014). take of added sugars (European Commission 2007; FAO/WHO
2014; Public Health England 2015; USDA 2015a; WHO 2013;
Why it is important to do this review
WHO-EURO 2014), for which SSB are the most important
Numerous studies have explored the effects of interventions aimed source among many population groups, including the USA gen-
at reducing the consumption of SSB or at increasing the consump- eral population (Drewnowski 2014). Environmental interventions
tion of low-calorie alternatives to SSB. A number of systematic show particular promise to be effective and cost-effective on a pop-
reviews on nutrition interventions in general have been published, ulation level (Gortmaker 2011; Roberto 2015; Swinburn 2011).
some of which include studies on interventions targeting SSB, A systematic synthesis of the available evidence in this field will
among others (Oldroyd 2008; Seymour 2004). Moreover, there help policymakers, regulators, health promotion authorities and
are systematic reviews on interventions altering specific aspects of professionals, and other relevant stakeholders to identify and im-
food and beverage environments, such as labelling (Hersey 2013; plement effective interventions in their own constituencies.
Rayner 2013; Swartz 2011), pricing (Andreyeva 2010; Wall 2006)
and portion sizes (Steenhuis 2009).
A number of non-systematic reviews on interventions to reduce
SSB consumption or to increase consumption of low-calorie al- OBJECTIVES
ternatives to SSB, including drinking water, have been published
(Hsiao 2013; Mello 2008; Moise 2011; Patel 2010; Pomeranz To assess the effects of environmental interventions (excluding tax-
2012; Tipton 2015). One systematic review and meta-analysis ation) targeted at sugar-sweetened beverages or low-calorie alter-
on SSB taxes has been published (Cabrera Escobar 2013), and natives to sugar-sweetened beverages on consumption levels, diet-
a Cochrane review on taxation of SSB for preventing obesity or related anthropometric measures and health outcomes, and on any
other adverse health outcomes is ongoing (Cochrane 2015a). One reported unintended consequences or adverse outcomes.
systematic review on interventions directed at SSB consumption
of youth has been published (Levy 2011), as well as one systematic
review on interventions to reduce SSB intake among children lead- METHODS
ing to changes in body fatness (Avery 2015). One mixed-methods
review on policies to reduce the intake of added sugar has been
published (Public Health England 2015). A Cochrane review pro-
Criteria for considering studies for this review
tocol on drinking extra water or other non-caloric beverages for
Types of studies
promoting weight loss or preventing weight gain has been pub-
lished (Burls 2016). We will consider the following study types, as recommended by
One systematic review on behavioural interventions to reduce SSB the Cochrane Effective Practice and Organization of Care (EPOC)
intake has been registered with the International Prospective Reg- Group (EPOC 2013a), using the definitions proposed by EPOC:
ister of Systematic Reviews (PROSPERO 2014a), as well as one • Randomised controlled trials (RCTs): Experimental studies
systematic review on interventions to reduce SSB intake in chil- in which people are allocated to different interventions using
dren and adults (PROSPERO 2014b). According to the published methods that are random. This includes both individually-
protocol, the latter will include behavioural and environmental randomised controlled trials, in which the randomisation occurs
interventions, considering randomised and non-randomised con- on the level of individuals, and cluster-randomised controlled
trolled trials from a number of academic databases (Vargas-Garcia trials (cluster-RCTs), in which the randomisation occurs on the
2015). In contrast, our review will focus on environmental in- level of clusters of individuals, e.g. study groups or study sites.
terventions only, and consider additional, uncontrolled study de- • Non-randomised controlled trials (NRCTs): Experimental
signs which are commonly used to assess the effects of policy in- studies in which people (individuals or clusters of individuals)
terventions. We will also search additional databases to identify are allocated to different interventions using methods that are
studies in the grey literature and policy documents. In addition, not random.
we will report a different set of outcome measures, including un- • Controlled before-after (CBA) studies: Studies in which
intended consequences, adverse outcomes and measures of cost- observations are made before and after the implementation of an
effectiveness that may be of relevance to policymakers. To the best intervention, both in a group that receives the intervention and
of our knowledge, no comparable systematic review, focusing on in a control group that does not. Unlike in NRCTs, the
environmental interventions (other than taxation) to reduce the allocation to the intervention and control groups is not
consumption of SSB among children, youth and adults has been determined by the investigators, but by nature or by other factors
outside the control of the investigators.
Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health (Protocol) 10
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
• Interrupted-time-series (ITS) study: A study that uses We will consider both ready-to-use SSB and SSB prepared from
observations at multiple time points before and after an syrups, concentrates or powder. We will also include interventions
intervention (the ‘interruption’). The design attempts to detect that use beverages with NNS as a substitute for SSB, or in which
whether the intervention has had an effect greater than any the energy content of SSB is reduced by substituting caloric sweet-
underlying trend over time. eners with NNS through reformulation. Full-fat milk and 100%
• Repeated measures study (RMS): An ITS study where fruit juice are, for the purpose of this review, not considered rec-
measurements are made in the same individuals at each time ommended alternatives to SSB. Interventions targeting these bev-
point. erages will not be included. We will try to present results sepa-
rately and examine and discuss differences in results for interven-
For the exact classification of study designs we will use the algo-
tions targeting SSB, sugar-sweetened milk, beverages with NNS,
rithm provided by EPOC (see Appendix 5).
or unsweetened beverages. Appendix 3 presents a list of all bever-
We will include only study designs that satisfy the following criteria
age categories included in this review and relevant definitions.
specified by EPOC (EPOC 2013a):
We will exclude the following:
• For cluster-RCTs, NRCTs and CBA studies: studies with at
• Studies conducted in laboratory or virtual settings, as the
least two intervention and two control sites.
results may not be generalisable to real-world environments.
• For ITS and RMS: a clearly defined point in time when the
• Studies with a follow-up period of less than three months,
intervention occurred and at least three data points before and
as the effects of environmental interventions may peter out due
three data points after the interventions.
to habituation, which may severely limit their long-term public
Randomised and non-randomised cross-over trials will be included health impact. In this review, we define the follow-up period as
if they satisfy the criteria specified by EPOC for their respective the time span between the start of the intervention and the last
study design. outcome assessment.
The inclusion of evidence from non-randomised controlled and • Very small studies with less than 20 individuals in the
uncontrolled study designs in systematic reviews is controver- intervention or control group, as the results may not be
sial (EPOC 2013a; Reeves 2008). While non-randomised study generalisable.
designs are commonly used for the evaluation of public health • Studies in which participants are administered SSB or
interventions, cluster-randomisation is feasible for most setting- alternatives to SSB as part of clinical trials on the physiological
based interventions which are of relevance to this review. Indeed, effects of SSB consumption, as these studies provide only limited
a number of RCTs of setting-based interventions targeting SSB evidence on the feasibility and effectiveness of public health
or low-calorie alternatives to SSB have been done (Bergen 2006; interventions aimed at reducing SSB intake among free-living
Giles 2012; Sichieri 2009). However, NRCTs and CBA studies are individuals outside controlled research settings. This may
more common (Bleich 2014; Block 2010; Blum 2008; Cradock include studies in which participants consume pre-defined
2011; Muckelbauer 2009; van de Gaar 2014; Visscher 2010). Even amounts of beverages under supervision, or in which bottled
though NRCTs, CBA studies, ITS studies and RMS are generally beverages are delivered for free to the homes of participants with
of higher risk of bias than RCTs, we have decided to include these additional measures taken to ensure and monitor compliance.
non-randomised study designs in order to cover a broader set of • Studies on interventions that combine components to
study populations, interventions types, and intervention contexts. reduce the consumption of SSB with broader components to
improve diet or increase physical activity, as it would be difficult
to attribute effects to the environmental or policy intervention of
Types of participants
interest. During the screening process we will document which
Any participants, including adults, adolescents and children, re- studies we exclude for this reason. We will provide a list of the
gardless of their weight and health status. citations to allow reflection on the quantity of relevant evidence
contained therein and consider to some extent how inclusion of
Types of interventions these studies might have influenced conclusions.
We will consider interventions that are intended to reduce the The comparison will be no intervention, minimal or alternative
consumption of SSB and sugar-sweetened milk, or their adverse interventions, such as behavioural intervention only.
effects on health, or to increase the consumption of low-calo-
rie alternatives to SSB, implemented at an environmental level.
Where these include behavioural (individual-level) components in Types of outcome measures
addition to environmental components, this will be clearly doc- Based on structured feedback from our Review Advisory Group,
umented. Stand-alone behavioural interventions will not be in- we identified a set of outcome measures that reflects short- and
cluded. We will exclude studies on taxation, as a separate Cochrane long-term health and non-health, and intended and unintended
review on taxation to reduce the consumption of SSB is ongoing. outcomes (see table 1). We will use SI units (i.e. the metric system)
Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health (Protocol) 11
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
to report results, except for energy, for which we will report both
joules and calories. Values reported in the primary studies will
be converted where necessary. To meet inclusion criteria, studies
must report at least one primary outcome. For reformulation in-
terventions that report effects on SSB consumption levels, at least
one additional primary outcome is needed to justify inclusion.
Outcomes Examples
Primary outcomes
Direct and indirect measures of SSB intake The amount of SSB consumed or purchased in mL/day/person, en-
ergy intake from SSB and total energy intake in kcal/day/person
Diet-related anthropometric measures Body mass index (BMI), age- and sex-standardised body mass index
(zBMI or BMI z-scores), waist circumference, waist-to-hip ratio, body
weight change, incidence and prevalence of overweight and obesity,
body composition or total body fat
Diet-related health outcomes (other than body weight) Incidence and prevalence of pre-diabetes and diabetes, insulin resis-
tance, blood lipids and blood pressure, incidence of dental caries and
other indicators of oral health
Any reported adverse outcomes or unintended consequences Compensatory behaviour, reduced fluid intake and dehydration, re-
duced intake of essential nutrients, body image changes, unhealthy
dietary practices, unhealthy weight control, perceived reduction of
freedom of choice and other forms of target group and stakeholder
dissatisfaction, negative effects on employment or other adverse eco-
nomic consequences
Secondary outcomes
Measures of financial and economic viability Costs, cost-effectiveness, return on investment, and staff time require-
ments
Diet-related psychosocial variables Perceived dietary self-efficacy, general self-efficacy, health-related and
general quality of life
Target group perceptions of the intervention Satisfaction with the intervention, satisfaction with the way the in-
tervention was implemented, support for the continuation of the in-
tervention
• Health:
Search methods for identification of studies ◦ MEDLINE
We will perform searches in the following databases: ◦ Embase (Excerpta Medica dataBASE)
Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health (Protocol) 12
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
◦ CENTRAL (Cochrane Central Register of Controlled be conducted in English, but we will consider studies published
Trials) in English, French, Spanish, Italian or German for inclusion. For
eligible studies in other languages we will attempt to arrange for
• Multidisciplinary:
translation. No restriction based on the year of publication will be
◦ Scopus
applied. The MEDLINE, Embase and CENTRAL search strate-
◦ Google Scholar
gies are shown in Appendix 6. They will be adapted to the rest of
◦ Social Science Citation Index
the above-mentioned databases.
• Public health, health promotion and occupational health
databases:
• ◦ BiblioMap (EPPI-Centre database of health Data collection and analysis
promotion research)
◦ TRoPHI (EPPI-Centre Trials Register of Promoting
Health Interventions)
Selection of studies
• Nutrition:
◦ eLENA (WHO e-Library of Evidence for Nutrition After removal of duplicate studies, we will perform a multistage
Actions) screening process to select those studies which meet the inclusion
criteria:
• Sources for grey literature: • Two review authors (PvP, JMS, JB, LKB, LMP or SP) will
◦ openGrey (formerly openSIGLE) independently assess all titles and abstracts, removing those
• Unpublished studies: which are not relevant. Disagreement will be resolved by
◦ ClinicalTrials.gov discussion, and where necessary by consulting a third review
◦ ICTRP (International Clinical Trials Registry author.
Platform) • In the second step, two review authors (PvP, JMS, JB, LKB,
• Databases with a regional focus: LMP, or SP) will independently assess all full texts selected in the
◦ LILACS first step. Disagreement will be resolved by discussion, and where
◦ SciELO Citation Index necessary by consulting a third review author.
We will use the Ovid search interface for MEDLINE, Embase and
At stage two of the screening process, we will document the rea-
CENTRAL.
sons for exclusion. EndNote will be used to collect and de-dupli-
In addition, we will search the websites of key organisations in
cate studies. For the screening of titles and abstracts and to doc-
the area of health, health promotion and nutrition, including the
ument inclusion and exclusion decisions, we will consider using
following:
appropriate software, including Abstrackr and Rayyan. Abstrackr
• EU platform for action on diet, physical activity and health
and Rayyan are web-based applications for facilitating citation
• U.S. National Institutes of Health
screening for systematic reviews (AHRQ 2015; Elmagarmid 2014;
• U.S. Centers for Disease Control and Prevention
Rathbone 2015). We will also consider using the web-based soft-
• Rudd Center for Food Policy and Obesity
ware application Covidence for full-text screening, ’Risk of bias’
• Harvard TH Chan School of Public Health Obesity
assessment, data extraction, and exporting of data to ReviewMan-
Prevention Source
ager 5.3. Covidence has been developed to streamline the writ-
• World Obesity
ing of systematic reviews, including Cochrane Reviews (Cochrane
We will handsearch reference lists of included studies and previ- 2015c; Covidence 2015).
ously published reviews, and we will contact the corresponding
author of included studies and previously published reviews as
well as the members of the Review Advisory Group to identify Data extraction and management
additional studies, including unpublished or ongoing studies. In Two review authors (PvP, JMS, JB, LKB, LMP, SP, CH, HH or
addition, we will conduct a citing studies search with Scopus, i.e. ER) will independently extract study characteristics and study data
we will search for studies that have cited included studies and pre- to the data extraction form. Inconsistencies between the two re-
viously published reviews and screen them for inclusion. view authors will be resolved by discussion, and where necessary
Our search strategy is based on three search sets, namely a bev- by consulting a third review author. The final agreed data will be
erage search set (including terms related to SSB and low-calorie entered into Review Manager 5.3 by PvP, and checked by a second
alternatives to SSB as well as to nutritive and non-nutritive sweet- review author (JMS, JB, LKB, LMP, or SP). In case of uncertain-
eners) an intervention search set (including terms on interven- ties, a third review author will be consulted.
tion areas, intervention types and study designs) and an outcome Based on our logic model (see Figure 5, page 9), we will extract
search set (including terms on outcome measures). Searches will and categorise data on the study population, intervention goals,
Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health (Protocol) 13
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
intervention areas, level and setting, comparison, delivery agents, EQUATOR (Enhancing the Quality and Transparency of Health
mode of delivery, and time frame of delivery, as well as on primary Research) network in collaboration with the CONSORT (Con-
and secondary outcomes and on intervention context and imple- solidated Standards of Reporting Trials) steering group to improve
mentation, including equity considerations. reporting of intervention characteristics in primary studies and in
A sufficiently detailed description of intervention characteristics systematic reviews (Hoffmann 2014), and has been recommended
is necessary for a meaningful interpretation of intervention out- to be used in Cochrane reviews (Cochrane 2015b; Köpke 2015).
comes. We will therefore use the TIDieR (Template for Interven- It contains items on 12 key intervention characteristics (see table
tion Description and Replication) framework to extract and report 2).
relevant data. The TIDieR framework has been developed by the
Table 2: The TIDieR framework (Template for Intervention Description and Replication)
Domain Description
WHAT (Procedures) The procedures, activities, and/or processes used in the interven-
tion
WHEN and HOW MUCH The schedule, duration, intensity or dose of the intervention
HOW WELL (planned) Strategies for the assessment and maintenance of intervention ad-
herence or fidelity
Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health (Protocol) 14
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
titioners (Armstrong 2008; Pfadenhauer 2015). We will therefore interests on SSB research (Bes-Rastrollo 2013; Cope 2009;
extract contextual data, using the categories defined by the CICI Massougbodji 2014), we will extract and document detailed infor-
(Context and Implementation of Complex Interventions) frame- mation on potential conflicts of interests and sources of funding
work. The CICI framework aims to capture relevant contextual of included studies.
data on several levels (including setting, community, the national The full data extraction form, including the CICI and the TI-
and international level) within the following eight thematic do- DieR frameworks and details on the included items, as well as a
mains (Pfadenhauer 2016): detailed version of the PROGRESS-Plus framework, are provided
• Locational in Appendix 7. We have piloted this form, using a selection of
• Geographical studies that would clearly be included to ensure that it allows ac-
• Epidemiological curate and reliable extraction of relevant data.
• Socio-economic
• Socio-cultural
• Political Assessment of risk of bias in included studies
• Legal Risk of bias of included studies will be independently assessed by
• Ethical two review authors (PvP, JMS, JB, LKB, LMP, SP, CH, HH or ER)
with the EPOC-adapted Cochrane Collaboration ’Risk of bias’
Large social gradients in SSB consumption and in SSB-related tool (Higgins 2008a, EPOC 2015, EPOC 2013b). Inconsistencies
health outcomes have been observed (Ogden 2011). Moreover, will be resolved by discussion, and where necessary by consulting
there is evidence that the recent decreases in average SSB consump- a third review author.
tion observed in some countries, such as the USA, have mainly The EPOC-adapted Cochrane ’Risk of bias’ tool has been vali-
been driven by decreases in consumption among relatively priv- dated, and is commonly used in Cochrane and non-Cochrane re-
ileged social groups (Bleich 2015). This suggests that recent at- views. For controlled study designs (RCTs, NRCTs, and CBA), the
tempts to curb SSB consumption may have reached disadvan- assessment is based on the following nine criteria (EPOC 2015):
taged groups to a lesser extent, a phenomenon observed with many • Was the allocation sequence adequately generated?
public health and health promotion interventions (Armstrong • Was the allocation adequately concealed?
2008). We will therefore examine whether included studies al- • Were baseline outcome measurements similar?
low conclusions with regard to differential outcomes for groups • Were baseline characteristics similar?
with varying levels and forms of disadvantage, as recommended by • Were incomplete outcome data adequately addressed?
the Cochrane-Campbell Equity Working Group (Tugwell 2010). • Was knowledge of the allocated interventions adequately
We will apply the PROGRESS-Plus framework for this pur- prevented during the study?
pose, which distinguishes nine domains in which social disadvan- • Was the study adequately protected against contamination?
tage may exist (Cochrane Campbell Methods Group 2011; Evans • Was the study free from selective outcome reporting?
2003; O’Neill 2014): • Was the study free from other risks of bias?
• Place of residence
• Race or ethnicity For ITS, the following seven criteria are applied (EPOC 2015):
• Occupation • Was the intervention independent of other changes?
• Gender • Was the shape of the intervention effect pre-specified?
• Religion • Was the intervention unlikely to affect data collection?
• Education • Was knowledge of the allocated interventions adequately
• Socio-economic status prevented during the study?
• Social capita • Were incomplete outcome data adequately addressed?
• Plus any additional dimensions of inequality discussed or • Was the study free from selective outcome reporting?
reported in the included studies • Was the study free from other risks of bias?
For each of these criteria, one of the following assessments is given:
On a global scale, the highest SSB consumption levels have been
• Low risk of bias: plausible bias unlikely to alter the results.
reported for upper- and lower-middle-income countries (Singh
• Unclear risk of bias: plausible bias that raises some doubt
2015). However, we expect that most studies eligible for inclusion
about the results.
will be from high-income countries. We will therefore pay special
• High risk of bias: plausible bias that seriously weakens
attention to issues of transferability and applicability of our con-
confidence in the results.
clusions to low- and middle-income countries, extracting, report-
ing and discussing contextual data concerning this issue, including We will use Review Manager 5.3 to apply the EPOC-adapted
data on resource needs. Cochrane ’Risk of bias’ tool, and to document results with traffic-
Given the controversies around the influence of conflicts of light coded ’Risk of bias’ tables (EPOC 2013b). In applying the
Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health (Protocol) 15
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
tool we will follow the relevant instructions as provided by EPOC tervention or control groups, and include two or more compar-
(EPOC 2015) and the Cochrane Handbook for Systematic Reviews isons, as specified by Cochrane guidelines (Higgins 2008b). In-
of Interventions (Higgins 2008a). dividually-randomised controlled trials and cluster-RCTs will be
For cluster-RCTs, additional potential sources of bias, including combined in the same meta-analyses or harvest plots, but will be
failure to take the correlated nature of within-cluster data into ac- clearly identified (Higgins 2008b).
count in the analysis will be considered within the domain “Was
the study free from other risks of bias?” (Higgins 2008b). For
multi-arm and cross-over trials, potential sources of bias specific Dealing with missing data
to these study designs will be considered as recommended by In case that missing data on study characteristics or outcome mea-
Cochrane guidelines (Higgins 2008b). sures precludes study inclusion or limits the use of a study at fur-
Conflicts of interests by study authors can introduce further ther stages of the review, we will contact the corresponding author.
sources of bias not captured by standardised assessment tools. For Missing data may include standard deviations for continuous out-
studies on SSB, two potential sources of bias relating to conflicts of come measures, sample sizes, standard errors or follow-up times
interest have been discussed: financial or other links to the food and (Higgins 2008b). For registered but unpublished trials, we will
beverage industry (Bes-Rastrollo 2013; Massougbodji 2014), and contact the corresponding investigator to request relevant data. If
“white hat bias” introduced by the zeal to achieve ends perceived studies do not report outcomes based on intention-to-treat analy-
as righteous, as well as by anti-corporate feelings, which might be ses, we will consider this as a source of bias within the domain “Was
present in researchers without industry links (Cope 2009). In the the study free from selective outcome reporting?” of the EPOC-
present review, we will extract and document any conflicts of in- adapted Cochrane ’Risk of bias’ tool. We will examine the effect of
terest reported in primary studies. If relevant conflicts of interest including results from studies without intention-to-treat analysis
are found, we will conduct sensitivity analyses, and discuss impli- by performing a sensitivity analysis for high or unclear risk of bias
cations for the interpretation of results. in the selective outcome reporting domain.
Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health (Protocol) 16
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
have any direct consequences for meta-analysis (see below). We Where meta-analysis is deemed inappropriate due to substantial
will create forest plots and I2 calculations using Review Manager clinical heterogeneity, we will summarise the findings of the in-
5.3. cluded studies narratively. The narrative summary will be under-
taken according to intervention type and comparison; within each
intervention type and comparison, the structure will be informed
Assessment of reporting biases by our logic model reporting on all major components (e.g. pop-
If more than 10 studies within the same intervention category and ulation, outcomes, context, implementation). We will use harvest
assessing comparable outcomes in the same population group are plots for a graphical representation of results. The harvest plot has
included, we will use funnel plots to assess the risk of reporting been developed to convey the findings of sets of studies of complex
bias, and perform statistical tests of asymmetry, including Begg’s interventions in a clear and transparent way, especially when meta-
and Egger’s tests (Sterne 2008). analysis is not appropriate (Crowther 2011; Ogilvie 2008). The
harvest plot is a matrix on which the distribution of evidence is
plotted using bars of different heights and shadings, each of which
Data synthesis stands for an outcome reported by one specific study (see Figure
We will attempt to pool all studies within a given intervention 6). The direction of an effect is indicated by the location of the bars
category (as defined by the NOURISHING framework) assessing on the matrix. Black bars stand for objective outcome measures,
the same outcome (e.g. SSB consumption or BMI change) in the and shaded bars stand for subjective, self-reported or self-assessed
same population group (e.g. individuals below or above 18 years outcome measures. The height of the bar indicates the suitability
of age) by conducting a meta-analysis using Review Manager 5.3. of study design, and the numbers stand for further methodolog-
If so, we will run separate meta-analyses for (i) RCTs, NRCTs and ical criteria (in this case a maximum of six) met by that study
cluster-RCTs, provided these have been adjusted for clustering, (ii) (Crowther 2011; Ogilvie 2008). We will develop one harvest plot
ITS and RMS, and (iii) CBA studies. Due to the expected large for each of the seven pre-specified intervention categories, using
heterogeneity in intervention delivery, setting and study popula- the rows for different outcome categories, as illustrated in Figure
tion we will use the random-effects model. 6.
Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health (Protocol) 17
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
lation to allocation concealment, baseline differences and incom-
Subgroup analysis and investigation of heterogeneity
plete outcome data. We will consider conducting an intra-cluster
We will consider performing separate meta-analyses, or creating correlation value sensitivity analysis for cluster trials.
separate harvest plots, for studies assessing interventions imple-
mented:
• at the policy or at the setting level; Quality of evidence
• with or without behavioural co-interventions; We will use the Grading of Recommendations Assessment, De-
• targeted at SSB, sugar-sweetened milk, beverages with NNS velopment and Evaluation (GRADE) system for grading the body
or at beverages without added sweeteners; of evidence for all critical and important outcomes (as defined
• implemented in high-, middle- or low-income countries; with the help of our Review Advisory Group). In the context of
• targeted at the general population or at disadvantaged GRADE, the quality of a body of evidence is understood as the
populations. extent to which one can be confident that an estimate of an effect
is close to the true effect (Guyatt 2008; Schünemann 2008). The
assessment will be summarised with a ’Summary of findings’ table
Sensitivity analysis created with the GRADEpro software.
We will examine how the time frame of the outcome measure- Within the GRADE approach, the quality of a body of evidence
ment, the unit of analysis, the risk of bias and the existence of is assessed based on the design of the underlying studies (where
relevant conflicts of interest affect results by conducting separate RCTs start off as high quality and all other study designs start off
meta-analyses or by creating separate harvest plots. This will in- as low quality), and on a number of factors which can decrease or
clude three separate meta-analyses or harvests plots that in turn increase the quality of evidence irrespective of study design. The
omit data from studies with a high or unclear risk of bias in re- four possible quality ratings are shown in table 3.
High quality Further research is very unlikely to change the confidence in the
estimate of effect
Low quality Further research is very likely to have an important impact on the
confidence in the estimate of effect and is likely to change the
estimate
There are five factors that can lead to a downgrading of the level
of evidence. If one of these factors is found to exist, it is classified • Indirectness of evidence (indirect population, intervention,
either as serious (downgrading by one level) or as very serious control, outcomes)
(downgrading by two levels): • Unexplained heterogeneity or inconsistency of results
• Risk of bias of individual studies (limitations in the design (including problems with subgroup analyses)
and implementation of available studies suggesting high • Imprecision of results (wide confidence intervals)
likelihood of bias) • High probability of publication bias
Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health (Protocol) 18
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
There are three factors increasing the quality of evidence, each of Hofman (University of Witwatersrand, South Africa), Artur Fur-
which can lead to an upgrading of the level of quality by one level: tado (European Commission), Mark Lawrence (Deakin Univer-
• Large magnitude of effect sity, Australia), Cintia Lombardi (Pan American Health Organiza-
• All plausible confounding would reduce a demonstrated tion), Rebecca Muckelbauer (Charité Universitätsmedizin Berlin,
effect or suggest a spurious effect when results show no effect. Germany), Modi Mwatsama (UK Health Forum, United King-
• Dose-response gradient dom), Sohyun Park (U.S. Centers for Disease Control and Preven-
tion, United States), Ludovic Reveiz (Pan American Health Or-
ganization), and Marc Suhrcke (University of York, United King-
dom).
ACKNOWLEDGEMENTS
We would like to acknowledge the substantial and generous con- Moreover, we would like to acknowledge the helpful contributions
tributions made by the members of our Review Advisory Group, by Lorainne Tudor Car (methodologist), Reza Yousefi Nooraie
who have helped to inform the background section and the param- (statistics advisor) and Patrick Condron (search specialist) as well
eters of the planned review. The members of the Review Advisory as the support provided by the Cochrane Public Health editorial
Group were María Eugenia Bonilla-Chacín (World Bank), Karen team.
REFERENCES
Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health (Protocol) 27
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
tea, and sugar-sweetened soft drink intake: pooled analysis
of prospective cohort studies. Journal of the National Cancer
Institute 2010;102(11):771–83.
Zheng 2015
Zheng M, Allman-Farinelli M, Heitmann BL, Rangan
A. Substitution of sugar-sweetened beverages with other
beverage alternatives: a review of long-term health
outcomes. Journal of the Academy of Nutrition and Dietetics
2015;115(5):767–79.
∗
Indicates the major publication for the study
APPENDICES
Dr. María Eugenia Bonilla-Chacín World Bank, Health, Nutrition and Population Global Practice
Mr. Artur Furtado European Commission, Directorate General for Health and Food Safety, Di-
rectorate for Public Health, Health Determinants Unit
Dr. Cintia Lombardi Pan American Health Organization/World Health Organization Regional Of-
fice for the Americas, Department of Noncommunicable Diseases and Mental
Health
Dr. Sohyun Park US Centers for Disease Control and Prevention, Division of Nutrition, Phys-
ical Activity, and Obesity
Dr. Ludovic Reveiz Pan American Health Organization/World Health Organization Regional Of-
fice for the Americas, Department of Knowledge Translation and Evidence
Knowledge Management, Bioethics and Research Office
Academia
Prof. Karen Hofman South Africa Medical Research Council Wits/Agincourt unit, PRICELESS SA,
University of Witwatersrand School of Public Health, Johannesburg, South
Africa
Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health (Protocol) 28
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)
Prof. Mark Lawrence Deakin University, School of Exercise and Nutrition Sciences, Burwood, Aus-
tralia
Dr. Rebecca Muckelbauer Charité - Universitätsmedizin Berlin, Institute for Public Health, Berlin, Ger-
many
Prof. Marc Suhrcke University of York, Centre for Health Economics, United Kingdom
Civil society
CI Certainty interval
GI Glycaemic index
GL Glycaemic load
Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health (Protocol) 29
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)
RR Risk ratio
Term Definition
Sugar-sweetened beverages (SSB) For the purpose of this review, SSB are defined as non-alcoholic,
non-dairy beverages with added caloric sweeteners. This defini-
tion includes, but is not limited to, carbonated and/or caffeinated
soft drinks (sodas), fruit juices with less than 100% fruit con-
tent and added sugar, sugar-sweetened energy and sports drinks,
sugar-sweetened vitamin waters and flavoured waters, and sugar-
sweetened coffee and tea. This includes both ready-to-use SSB
and SSB prepared from syrups, concentrates or powder. SSB may
contain non-nutritive sweeteners (NNS) in addition to caloric
sweeteners. Beverages containing coffee and added sugars that are
primarily milk-based, such as latte macchiato or cappuccino, are
not included in this definition, but will be considered within the
category of sugar-sweetened milk
Sugar-sweetened milk Milk and milk-based beverages with added caloric sweeteners.
NNS may or may not be present in addition to caloric sweeteners.
For the purpose of this review, and following the Scientific Report
of the 2015 U.S. Dietary Guidelines Advisory Committee as well
as the Dietary Guidelines for Americans 2015-2020, we consider
fortified soy beverages, but not almond or other plant-based “milk-
type” products as substitute for milk. This definition includes
Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health (Protocol) 30
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)
Low-calorie alternatives to SSB Non-alcoholic beverages without added caloric sweeteners. These
may be beverages without any added sweeteners, or beverages
sweetened exclusively with NNS (see below)
Beverages without added sweeteners Any non-alcoholic beverage without any added sweeteners. This
includes drinking water, unsweetened tea and coffee, and low-fat
or fat-free unsweetened milk (including fortified soy beverages)
, among others. For the purpose of this review, full-fat milk and
100% fruit juice are not included, while beverages prepared by
adding 100% fruit juice to carbonated or uncarbonated water
without adding additional caloric sweeteners are included
Beverages sweetened exclusively with non-nutritive sweeteners Any non-alcoholic beverage exclusively sweetened with NNS.
This may include low-fat or fat-free milk sweetened exclusively
with NNS. Beverages containing both caloric sweeteners and NNS
will be considered as reformulated SSB
Non-nutritive sweeteners (NNS) NNS, also referred to as low-calorie, low-energy or artificial sweet-
eners, are chemically diverse compounds with no or minimal
caloric content and a sweet taste of varying intensity
Appendix 4. The NOURISHING framework used for the classification of intervention areas
Adapted and reprinted with permission from the World Cancer Research Fund International (WCRFI 2015). In our scoping literature
search we searched for intervention studies reporting intervention effects on SSB consumption levels, excluding studies on taxation
and behavioural interventions without environmental components.
FOOD ENVIRONMENT
Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health (Protocol) 31
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)
Nutrition label standards and regula- e.g. Nutrient lists on food packages; clearly Energy-content labels at SSB vending ma-
tions on the use of claims and implied visible ‘interpretive’ and calorie labels; chines (Bergen 2006) and in neighbour-
claims on foods menu, shelf labels; rules on nutrient and hood stores (Bleich 2014).
health claims
Offer healthy foods and set standards in e.g. Fruit and vegetable programmes; stan- Interventions to improve the availability
public institutions and other specific set- dards in education, work, health facilities; and convenience of drinking water and
tings award schemes; choice architecture other low-calorie beverages in schools (
Giles 2012, Muckelbauer 2009, van de
Gaar 2014, Visscher 2010, Laurence 2007)
.
Interventions limiting access to SSB in in-
dividual schools (Blum 2008, Cullen 2006)
and at workplaces (Eneli 2014), includ-
ing restrictions to sugar-sweetened milk
(Hanks 2014, Quann 2013).
National and sub-national school nutrition
policies limiting access to SSB, and im-
proving access to low-calorie alternatives to
SSB (Woodward-Lopez 2010, Fung 2013,
Cullen 2008, Cradock 2011, Bae 2012).
Industry self-regulation limiting sales of
SSB at schools (American Beverage
Association 2010).
Use economic tools e.g. Targeted subsidies; price promotions Price changes to SSB and alternatives to
to address food affordability and pur- at point of sale; unit pricing; health-related SSB in work site cafeterias (Block 2010).
chase incentives food taxes Taxation of SSB (not covered by this re-
view, for an existing systematic review see
Cabrera Escobar 2013).
Restrict food advertising and other e.g. Restrict advertising to children that No intervention studies reporting effects
forms of commercial promotion promotes unhealthy diets in all forms of on SSB consumption identified in our
media; sales promotions; packaging; spon- scoping literature search. For a review of in-
sorship tervention effects on advertisement expo-
sure see (Galbraith-Emami 2013).
Improve the nutritional quality of the e.g. Reformulation to reduce salt and fats; Unit size changes to SSB and low-calorie
whole food supply elimination of transfats; reduce energy den- alternatives to SSB implemented at school
sity of processed foods; portion size limits cafeterias (Hartstein 2008).
Interventions altering the caffeine content
of SSB (Keast 2015).
Set incentives and rules to create a e.g. Incentives for shops to locate in under- Urban planning policies limiting new fast
healthy retail and food service environ- served areas; planning restrictions on food food restaurants serving SSB (Sturm 2015)
ment outlets; in-store promotions .
FOOD SYSTEM
Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health (Protocol) 32
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)
Harness the food supply chain and ac- e.g. Supply-chain incentives for produc- No intervention studies identified in our
tions across sectors to ensure coherence tion; public procurement through ‘short’ scoping literature search
with health chains; health-in-all policies; governance
structures for multi-sectoral engagement
Inform people about food and nutrition e.g. Education about food-based dietary Education and awareness-raising on the
through public awareness guidelines, mass media, social marketing; health effects of different beverage choices
community and public information cam- delivered at schools (Muckelbauer 2009,
paigns van de Gaar 2014, Fung 2013, Laurence
2007) and work sites (Block 2010).
Motivational posters at beverage vending
machines (Bergen 2006).
Nutrition advice and counselling in e.g. Nutrition advice for at-risk individu- No intervention studies identified in our
health care settings als; telephone advice and support; clinical scoping literature search
guidelines for health professionals on effec-
tive interventions for nutrition
Give nutrition education and skills e.g. Nutrition, cooking/food production Skills development activities at schools (
skills on education curricula; workplace Laurence 2007).
health schemes; health literacy programmes
Appendix 5. The EPOC algorithm used for the classification of study designs
Figure 7
Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health (Protocol) 33
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Figure 7. Algorithm for the classification of study designs. Reproduced with permission from EPOC 2013a.
Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health (Protocol) 34
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Appendix 6. Search strategy for MEDLINE, Embase and CENTRAL
Search Strategy for MEDLINE, Embase and CENTRAL
MEDLINE Search Strategy
The search syntax has been developed for use with the Ovid search interface. The numbers of results provided below are from a test
run conducted on March 13, 2016 in the database Ovid MEDLINE(R) 1946 to March Week 1 2016.
Beverage search set (containing terms related to SSB and low-calorie alternatives to SSB, as well as to nutritive and non-
nutritive sweeteners)
3 Carbonated Water/ 32
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(Continued)
13 or/1-12 58862
Intervention search set (containing terms related to intervention types, intervention areas and study designs)
22 Serving Size/ 14
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Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)
30 or/14-29 2634083
32 Drinking/ 12885
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(Continued)
40 or/31-39 1818089
45 or/42-45 6319854
47 46 not 45 4244
Beverage search set (containing terms related to SSB and low-calorie alternatives to SSB, as well as to nutritive and non-
nutritive sweeteners)
2 carbonated water/ 52
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(Continued)
13 or/1-12 86540
Intervention search set (containing terms related to intervention types, intervention areas and study designs)
Environmental interventions to reduce the consumption of sugar-sweetened beverages and their effects on health (Protocol) 39
Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)
24 or/14-23 3140331
26 drinking/ 18428
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(Continued)
37 or/25-36 2675008
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Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Beverage search set (containing terms related to SSB and low-calorie alternatives to SSB, as well as to nutritive and non-
nutritive sweeteners)
2 Drinking Water/ 44
3 Carbonated Water/ 3
4 Energy Drinks/ 37
13 or/1-12 2743
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Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Intervention search set (containing terms related to intervention types, intervention areas and study designs)
17 Food Labeling/ 63
18 Product labelling/ 38
21 Portion Size/ 24
22 Serving Size/ 4
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(Continued)
30 or/14-29 660229
32 Drinking/ 463
41 or/31-40 136188
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Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Joint search sets
Study eligibility:
• Intervention:
◦ Are any of the intervention’s main components intended to, or potentially suitable to limit the health effects of SSB
consumption, or to increase the consumption of low-calorie alternatives to SSB? (Yes or No)
◦ Definition of SSB used in the study / type of SSB targeted by the intervention
◦ Definition of alternatives to SSB used in the study / type of alternative beverage targeted by the intervention:
◦ Is the intervention an environmental intervention, i.e. is it trying to permanently alter the environment in which
individuals make beverage choices? (Yes or No)
◦ Any further relevant comments regarding the eligibility of the intervention
◦ Does the intervention satisfy the inclusion criteria? (Yes or No)
• Level of implementation:
◦ What was the level of implementation of the intervention? (Policy or Setting-based intervention)
• Study design:
◦ What is the design of the study? (RCT, NRCT, CBA, ITS, UBA, or Other; if other, please specify)
◦ In case the study design is a NRCT, CBA or ITS, does it fulfil the EPOC criteria? (Yes, No, or Not applicable)
◦ Comment on adherence to EPOC criteria
◦ Does the study design satisfy the inclusion criteria? (Yes or No)
◦ Any further relevant comments regarding the eligibility of the study design
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• Outcomes:
◦ Does the study assess any of the primary outcomes?
◦ Do the outcomes reported satisfy the inclusion criteria? (Yes or No)
◦ Any further relevant comments regarding the eligibility of the outcome measures
• Further exclusion criteria:
◦ Is any of the following exclusion criteria fulfilled?
⋄ The intervention is implemented in a laboratory
⋄ The intervention is implemented in a virtual setting
⋄ The follow-up period is less than three months (In this review, the follow-up period is defined as the time span
between the start of the intervention and the last outcome assessment)
⋄ There are less than 20 individuals in the intervention or control group
⋄ The study is a clinical trial on the physiological effects of SSB
◦ Is one or more of the above exclusion criteria fulfilled? (Yes or No)
◦ Any further relevant comments regarding the above mentioned exclusion criteria
• Summary of study eligibility:
◦ Regarding the study design, intervention, outcomes and further exclusion criteria, does the study meet all inclusion criteria?
(Yes or No)
◦ Any further relevant comments regarding the study eligibility, including uncertainties or concerns
Timing:
• Start of the study (i.e. the date of the baseline assessment)
• End of the study (i.e. the date of the last outcome assessment)
• Start of the intervention (i.e. the start date of the implementation of the first intervention component)
• End of the intervention(i.e. the date when the last intervention component was discontinued; in case the intervention was not
discontinued within the study period, enter the last reported date instead)
• Duration of the intervention (i.e. the time span from the start of the intervention to the end of the intervention)
• Total duration of the follow-up (i.e. the time span from the start of the intervention to the date of the last outcome assessment)
• Was there an additional follow-up period after the end of the intervention? (I.e., was the total follow-up period longer than the
duration of the intervention?) (Yes or No)
• If yes, duration of the additional follow-up after the end of the intervention
• Any other relevant information regarding intervention timing?
Study design:
• Unit of randomisation or control (allocation by individuals or clusters/groups)
• Unit of analysis
• Is the unit of randomisation or control the same as the unit of analysis? (Yes, No, or Unclear)
• If yes, was this taken into account in the analysis? (Yes, No, or Unclear)
• Details on unit of randomisation, control and analysis issues, and on the way how these were taken into account in the analysis
• Total number of persons in all intervention and control groups at baseline (or total number randomised for RCTs)
• Number of individuals in each intervention and control group (for cluster trials, include the number of individuals and the
number of clusters)
• Mode of analysis (Intention-to-treat, Per protocol, or Unclear =
• Please provide details on the mode of analysis(e.g. on attempts to impute missing data)
• Was a subgroup analysis done? (Yes or No; if yes, please provide details)
• Is any information on moderators or mediators of effectiveness discussed in the study? (Yes or No; if yes, please provide details)
• Was a power calculation done? (Yes or No; if yes, please provide details)
Participants:
• General Characteristics:
◦ General description of the participants(e.g. school children aged 7-12 in four schools in Chicago)
◦ Was the intervention targeted at specific age categories? (No, Children, Teenagers, Adults, or Other)
◦ Details on the age of the participants
◦ List of all inclusion and exclusion criteria for study participation (in case of cluster-randomised studies include details both
for clusters and for individuals within clusters)
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• Recruitment:
◦ How were potential participants approached and invited to participate?
◦ Where were participants recruited from?
• Baseline assessment:
◦ How were baseline differences between study groups assessed?
◦ List any baseline differences found
◦ Was baseline body weight of participants higher than the average of their population? (Yes or No)
◦ Details on the baseline weight status of the participants
◦ Did participants have at baseline any existing medical conditions or physiological risk factors other than overweight or
obesity? (Yes or No)
◦ Details on the baseline health status of the participants (Yes or No)
◦ Was the baseline SSB consumption of participants higher than the average of their population?
◦ Details on the baseline SSB consumption of the participants
◦ Representativeness of the sample
• Equity considerations (PROGRESS-Plus framework):
◦ Place of residence
◦ Race or ethnicity
◦ Occupation
◦ Gender
◦ Religion
◦ Education
◦ Socio-economic status
◦ Social capital
◦ Any other information of potential relevance to equity considerations (e.g. disability)
• Any other relevant data regarding participant characteristics
Intervention and Comparison:
• How many groups were assessed in total?
• What was the comparison? (No intervention, Behavioural intervention only, Minimal intervention, or Other)
• Further comments on the comparison
In case there are several intervention groups, or if the comparison was a minimal, behavioural or alternative intervention, the following section
should be copy-pasted and used for each intervention or active control group.
Intervention:
• Description of the intervention (TIDieR framework):
◦ BRIEF NAME: The name or phrase that describes the intervention
◦ WHY: The rationale, theory, or goal of the elements essential to the intervention
◦ WHAT (Materials): The physical or informational materials used in the intervention
◦ WHAT (Procedures): The procedures, activities, and/or processes used in the intervention
◦ WHO PROVIDED: The expertise, background and training of intervention providers
◦ HOW: The modes of delivery of the intervention (e.g. face-to-face, or by internet or telephone)
◦ WHERE: The type(s) of location(s) where the intervention occurred
◦ WHEN and HOW MUCH: The schedule, duration, intensity or dose of the intervention
◦ TAILORING: Any personalisation, titration or adaption of the intervention to individual participants
◦ MODIFICATIONS: Modification of the intervention during the study
◦ HOW WELL (planned): Strategies for the assessment and maintenance of intervention adherence or fidelity
◦ HOW WELL (actual): Extent of the intervention adherence or fidelity
• Categorisation of the intervention:
◦ What type of intervention was performed? (not applicable for the intervention groups):
⋄ Labelling
⋄ Limits to the availability of SSB
⋄ Improved access to low-calorie alternatives to SSB
⋄ Pricing
⋄ Advertisement / marketing
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⋄ Nutritional content / reformulation
⋄ Food system intervention
⋄ Other
⋄ If other, please specify
◦ What type of behavioural co-intervention (or control intervention) performed?
⋄ None
⋄ Behavioural co-intervention (information / awareness-raising)
⋄ Behavioural co-intervention (nutrition advice and counselling for at-risk individuals)
⋄ Behavioural co-intervention (skills-building)
⋄ Other
⋄ If other, please specify
In the following section, information on all primary and secondary outcomes will be extracted. It will be copy-pasted in case more than one
outcome is reported.
Outcomes:
• Select the outcome that was assessed:
◦ Primary outcomes:
⋄ Direct and indirect measures of SSB intake (e.g. the amount of SSB consumed or purchased in ml/day/person, energy
intake from SSB and total energy intake in kcal/day/person)
⋄ Diet-related anthropometric measures (e.g. BMI, waist circumference, waist-to-hip ratio, body weight change,
incidence and prevalence of overweight and obesity, body composition or total body fat)
⋄ Diet-related health outcomes other than body weight (e.g. incidence and prevalence of pre-diabetes and diabetes,
insulin resistance, blood lipids and blood pressure, incidence of dental caries and other indicators of oral health)
⋄ Any reported adverse outcomes or unintended consequence (e.g. compensatory behaviour, reduced fluid intake and
dehydration, reduced intake of essential nutrients, body image changes, unhealthy dietary practices, unhealthy weight control,
perceived reduction of freedom of choice and other forms of target group and stakeholder dissatisfaction, negative effects on
employment or other adverse economic consequences).
◦ Secondary outcomes:
⋄ Measure of financial and economic viability and sustainability (e.g. costs, cost-effectiveness, return on investment, and
staff time requirements)
⋄ Diet- and nutrition-related psychosocial variable (e.g. perceived dietary self-efficacy, general self-efficacy, health-related
and general and quality of life)
⋄ Measure for target group and stakeholder perceptions of the intervention (e.g. satisfaction with the intervention,
satisfaction with the way the intervention was implemented, support for the continuation of the intervention)
• Exact description of the outcome
• How the outcome was assessed
• By whom the outcome was assessed
• Has the assessment tool or measurement method been validated? (Yes, No, or Unclear)
• Details on the validation of the assessment tool or measurement method
• Has the assessment tool or measurement method been used as validated? (Yes, No, or Unclear)
• Details on whether the validation of the assessment tool or measurement method has been used as validates
• Is the assessment or measurement repeated on the same individuals or redrawn from the population for each time point? (Yes,
No, or Unclear)
• Description of the time points at which the outcome was measured
• Description of the time points at which the outcome was analysed
• Description of the statistical method applied
• Description of any methods used for adjustment
• Number of participants in group and attrition rate
• Reasons for attrition, if provided
• Baseline, Follow-up and Post-intervention means of the intervention group and the control or comparison (Including variance
measure and indication of whether measures are adjusted or not, and indication of significant differences were shown)
• Effect estimate, if given (e.g. odds ratio, risk ratio, regression coefficients)
• Narrative summary of results for this outcome
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Adverse outcomes or unintended consequences:
• Does the study mention whether adverse outcomes or unintended consequences occurred? (This includes adverse or unintended
consequences on the broader context, such as employment effects)
◦ Yes (study states explicitly that there were no adverse outcomes)
◦ Yes (study states explicitly that there were adverse outcomes)
◦ No (study does not mention whether adverse outcomes were observed or not)
• Details on the statement of adverse outcomes or unintended consequences
• Does the study provide any information on how information on possible adverse outcomes was collected? (e.g. through a critical
incident reporting system, anonymous feedback options, explicit screening for adverse outcomes in the process evaluation, etc) (Yes, No, or
Unclear)
• Were any precautions made to avoid adverse outcomes or unintended consequences? (Yes, No, or Unclear)
• Any information on adverse outcomes or unintended consequences not captured above
Attribution of outcomes:
• Does the study provide information on the possibility of attributing specific outcomes to specific intervention components? (e.g.
whether some intervention components were more effective than others)
◦ Yes (Attribution is possible)
◦ Yes (Attribution is not possible)
◦ No (No information provided)
• Details on attribution of outcomes
(Note: Setting aspects, which are also part of the CICI framework, are already captured by the TIDeR framework, and are therefore not
duplicated here.)
• Implementation:
◦ Which funding measures and mechanisms are applied and how do these mechanisms and processes enable or limit
implementation?
◦ In which policy field was the intervention implemented? (Education, Health care, Consumer protection, Food safety,
Media and marketing regulation, or Other)
◦ In which sector was the intervention implemented? (Public sector, Private not-for-profit, Private for profit, or Other)
◦ What was the mode of implementation? (Pilot trial by researchers, Voluntary action by private actors other than industry
(e.g. non-governmental organizations, philanthropy), Mandatory government regulation, Industry self-regulation, Public-private
partnership, or Other)
◦ Was resource-intensity or cost-effectiveness of the intervention discussed by the authors? Were resource-intensity and cost-
effectiveness considerations in the study development?
◦ Was sustainability discussed by the authors? (i.e. whether the intervention is likely to persist after the end of the study
period) Was sustainability a consideration in the study development?
◦ Was political viability and sustainability discussed by the authors? (i.e. the ease of political implementation, and the
likelihood that the intervention is reversed after the end of the study due to political reasons) Was political viability and sustainability
a consideration in the study development?
◦ Were barriers to implementation before and during the intervention discussed by the authors? Were barriers to
implementation a consideration in the study development?
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◦ Was scalability discussed by the authors? (i.e. whether the intervention is suitable to be implemented on a larger scale) Was
scalability a consideration in the study development?
◦ Was generalisability discussed by the authors? (i.e. whether the intervention is suitable to be implemented in other contexts
with similar results) Was generalisability a consideration in the study development?
CONTRIBUTIONS OF AUTHORS
PvP drafted the protocol with support from JMS, JB, LKB, LMP, SP, CH, HH and ER. The search strategy was developed by PvP,
and the data extraction form by PvP and JB. JB, LKB, LMP, SP and ER provided methodological support at all stages of protocol
development.
DECLARATIONS OF INTEREST
CH is a member of the scientific advisory board of 4sigma, a consultancy working primarily for health insurance companies. She has
been involved in the preparation of a systematic review on Associations between single nucleotide polymorphisms and macronutrient
intake (PROSPERO: CRD42015025738), partly funded by an institutional grant from the consumer products company Amway
GmbH. CH is fully involved in all steps of this systematic review.
HH has received honoraria for membership on scientific advisory boards of Weight Watchers, NovoNordisk and Boehringer Ingelheim.
His institution has received grants from Riemser Pharma, Amway GmbH and Certmedica, a producer of slimming products. HH has
received honoraria for membership on scientific advisory boards of Nestle and Danone, providing advice on recommendations regarding
the nutritional content of breakfast meals and dairy products. Nestle and Danone produce, among others, both sugar-sweetened foods
and beverages and alternatives to sugar-sweetened foods and beverages.
All other authors have no conflicts of interest to declare.
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