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ARTICLE IN PRESS

Public Health (2007) 121, 510–517

www.elsevierhealth.com/journals/pubh

Original Research

A systematic review of controlled trials of


interventions to prevent childhood obesity and
overweight: A realistic synthesis of the evidence
J.B. Connellya,, M.J. Duasob, G Butlerc

a
Institute of Health Sciences, The University of Reading, London Road, Reading RG1 5AG, UK
b
School of Health and Social Care, The University of Reading, Reading, UK
c
School of Psychology, The University of Reading, Reading, UK

Received 16 May 2006; received in revised form 10 October 2006; accepted 15 November 2006
Available online 30 April 2007

KEYWORDS Summary Background: Preventing childhood overweight and obesity has become a
Obesity; major public health issue in developed and developing countries. Systematic reviews
Prevention; of this topic have not provided practice-relevant guidance because of the generally
Child; low quality of research and the heterogeneity of reported effectiveness.
Controlled clinical Aim: To present practice-relevant guidance on interventions to reduce at least one
trials; measure of adiposity in child populations that do or do not contain overweight or
Exercise obese children.
Design: Systematic review of eligible randomized, controlled trials or controlled
trials using a novel approach to synthesizing the trial results through application of
descriptive epidemiological and realistic evaluation concepts. Eligible trials involved
at least 30 participants, lasted at least 12 weeks and involved non-clinical child
populations.
Results: Twenty-eight eligible trials were identified to 30 April 2006. Eleven trials
were effective and 17 were ineffective in reducing adiposity. Blind to outcome, the
main factor distinguishing effective from ineffective trials was the provision of
moderate to vigorous aerobic physical activity in the former on a relatively
‘compulsory’ rather than ‘voluntary’ basis.
Conclusions: By using a novel approach to synthesizing trials, a decisive role for the
‘compulsory’ provision of aerobic physical activity has been demonstrated. Further
research is required to identify how such activity can be sustained and transformed
into a personally chosen behaviour by children and over the life course.
& 2007 The Royal Institute of Public Health. Published by Elsevier Ltd. All rights
reserved.

Corresponding author. Tel.: +44 118 378 5979; fax:+44 118 378 6808.
E-mail address: jbconn7@aol.com (J.B. Connelly).

0033-3506/$ - see front matter & 2007 The Royal Institute of Public Health. Published by Elsevier Ltd. All rights reserved.
doi:10.1016/j.puhe.2006.11.015
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Prevention childhood obesity and overweight 511

Introduction Methods
The prevalence of overweight and obesity in Search strategy
children and adolescents is an increasing
problem in the UK,1 Europe,2 Australia3 and the We used the search strategy and inclusion criteria
USA.4 The World Health Organization, using its described by Summerbell et al.6 applied to the
criterion of a prevalence above 15%, has declared following electronic databases: Medline, Embase,
overweight and obesity in children a global epi- Cinhal, PsycINFO up to 30 April 2006. This identified
demic.5 randomized, controlled trials or controlled trials of
Previous systematic reviews of controlled interventions to prevent overweight or obesity in
trials of interventions to prevent overweight populations that included non-overweight children
and obesity in childhood and adolescents have with or without overweight or obese children. Trials
not supplied practice-relevant guidance. Summer- had to include an outcome that measured an index
bell et al.6 reviewed 22 controlled trials and of adiposity. The ages included were 0–18 years and
concluded that ‘‘the mismatch between the the follow-up was at least 12 weeks. We also
prevalence and significance of the condition searched the reference lists of included trials and
and the knowledge base from which to inform published reviews for potentially relevant studies.
preventions activity continues to be remarkable’’. We noted reasons for excluding papers that had
Reilly and McDowell7 excluded all but three seemed eligible but were found ineligible.
trials on the grounds that the design quality
of the rest was too low for their results to be
Quality appraisal of trials
valid and therefore relevant as guides to practice.
They concluded that ‘‘the evidence base for
Each included paper was read by two researchers
interventions in childhood activity, with the aim
who independently scored them using the quality
of prevention on treatment of obesity, remains
checklist devised by Downs and Black;12 any
limited. Simple, effective and generalizable inter-
disagreements were settled by discussion.
ventions are lacking’’. In contrast, Thomas et al.8
concluded that increasing physical activity rather
than skill development classes should be advo- Intensity score
cated, and that the number of physical activity
classes in which a student could enrol could be Four elements a priori and independent of the
increased. effectiveness of each trial were considered to be
Three reasons justify the current systematic important in providing an estimate of the potential
review and distinguish it from those already efficacy of the intervention used in each trial
published. First, we used both descriptive (Table 1). These elements were specified because
epidemiological and realistic evaluation concepts of indications from published reviews or from a
and procedures to cross-classify and synthesize realist perspective on mechanisms. In particular,
the controlled trials we identified. We believe ‘compulsory’ provision of aerobic physical activity
this approach offers more analytic power in was distinguished from ‘voluntary’ provision.
identifying and explaining heterogeneity of trial
results than a more traditional trial by trial Agreement of ‘compulsory’ judgement
narrative description. Second, most of the existing
reviews, as with more than half of the Cochrane Two researchers (JC, MD) classified the physical
reviews on all topics, fail to draw practice-relevant activity intervention as ‘compulsory’ or ‘voluntary’
conclusions,9 as shown by Summerbell et al6 and (Table 1) blind to outcome. Chance-corrected
Reilly and McDowell.7 Thomas et al.8 are excep- agreement (Kappa statistic)13 was estimated.
tional in putting forward a more positive conclu-
sion, but their advice is not very specific. Finally, Data extraction from the trials
realistic evaluation specifies the particular impor-
tance of thoroughly describing the putative me- A proforma was constructed to allow a systematic
chanisms that are expected to underlie the changes recording of data from each trial. Data items were
brought about by the intervention.10,11 Thus, as follows: reference number; first author; year of
specifying elements that on realistic analysis are publication; country of the trial, design; unit of
expected a priori to cause a change grounds the analysis; age group; ethnicity; numbers in each
reasons for choosing sub-groups to explore before group; description of intervention; results; re-
synthesizing the evidence. searcher’s comments; appraisal comments; quality
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512 J.B. Connelly et al.

Table 1 Elements of an effective intervention: the intensity score.

1. Intervention based on an explicit theory or on pilot studies or formative research Yes ¼ 1


No ¼ 0

2. Intervention implemented by the researchers Yes ¼ 1


No ¼ 0

3. Physical activity judged to be compulsory rather than voluntary: ‘compulsory’ is Yes ¼ 1


defined by more than one of the following: integrated into the curriculum; expectation No ¼ 0
of adherence and attendance; moderate to vigorous aerobic activity, personal goals set
and monitored; course credits given; supervised on level of intensity. ‘Voluntary’ is
defined by more than one of: encouragement to take part; opportunities given to take
part; muscle strengthening or other non-aerobic activity; use of role-modelling; non-
supervised on level of intensity
4. Multi-component intervention Yes ¼ 1
No ¼ 0

score; intensity score; and effectiveness. Consid-


Table 2 Studies included in the systematic review,
erations based upon realism produced four ele- classified by effectiveness on adiposity.
ments that comprised a measure of the ‘intensity’
of the intervention (see above). Effective Ineffective

Simonetti D’Arca et al. Sallis et al. (1993)16


Procedures for synthesizing studies (1986)15
Flores (1995)17a Leupker et al. (1996)19
We used both epidemiological14 and realistic Vandongen et al. Donnelly et al. (1996)20
evaluation10,11 concepts and procedures. Descrip- (1995)18
tive epidemiology clarifies and classifies units of Mo-Suwan et al. Stolley and Fitzgibbon
analysis (here the units are individual studies) by (1998)22a (1997)21
using categories of time, place and person. Robinson (1999)23 Sahota et al. (2001)25
Realistic evaluation examines characteristics be- Gortmaker et al. Epstein et al. (2001)27
(1999)24a
tween studies reporting effective and ineffective
Muller et al. (2001)26 Robinson et al. (2003)28
outcomes. The resulting classifications may show Sallis et al. (2003)29b Caballero et al. (2003)30
patterning, which indicates causal mechanisms and James et al. (2004)37 Newmark-Sztainer et al.
cause-relevant contextual features.10 (2003)31
Kain et al. (2004)39 Harvey-Berino (2003)32
Results Fitzgibbon et al. Warren (2003)33
(2005)40
Baranowski et al.
We identified 28 eligible trials published up to 30
(2003)34
April 2006.15–42 Concerning at least one measure of Beech et al. (2003)35
adiposity, 11 trials reporting a statistically signifi- Pangrazi et al. (2003)36
cant decrease between the intervention compared Dennison et al. (2004)38
with the controlled condition (‘effective’) and 17 Coleman et al. (2005)41
trials that did not show such a difference (‘in- Ramirez-Lopez et al.
effective’) (Table 2). (2005)42
a
Effective in girls only.
Summary and synthesis of the trials b
Effective in boys only.

No apparent association was observed between a


trial’s quality score and its reported effectiveness
regarding a measurement of adiposity. Table 3 children was between 6 and 10 years in 19 trials,
summarizes the 28 trials and may be read for five of these showed an effect on a measure of
summary purposes or for individual trial design adiposity, one trial included boys only and eight
features and results. For example, the mean age of trials included girls only. Of the effective trials,
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Prevention childhood obesity and overweight 513

two15,22 included pre-school children (these trials Realism was used in this systematic review to
both used a school setting and one used a physical ‘open up the black box’ of the intervention(s).
intervention),15 and the other used physical educa- Before classifying studies on effectiveness, we
tion information and compulsory physical activity.22 devised four components that we considered to
Table 4 (online version only) shows the trials in the be relatively independent measures of the ex-
traditional narrative style. pected effectiveness of the intervention, the
Table 3 shows the results of a descriptive intensity score. These components were: (1) the
epidemiological and realist comparison between theoretical basis of the intervention, if any,
‘effective’ and ‘ineffective’ trials. The most strik- including pilot and formative research; (2) whether
ing difference is in the ‘compulsory physical the researchers themselves provided the inter-
activity’ category, which shows that five trials, vention on the assumption that if they did this
which provided relatively compulsory, weekly, would increase conformity of effort and comp-
aerobic, physical activity, were effective and no liance with the protocol; (3) whether the
trial proved ineffective. The probability of such a provision of physical activity was judged as ‘com-
5–0 distribution, on a null hypothesis of equal pulsory’ or ‘voluntary’; here, we believed
chances of (in) effectiveness is about 3%. Given the that ‘compulsory’ provision would increase adher-
a priori importance of ‘compulsory’ aerobic physi- ence and thus contribute to impact; and (4)
cal activity based upon realist considerations, two whether the intervention had more than one
researchers independently classified interventions element (e.g. nutritional education and training
as ‘compulsory’ or ‘voluntary’ aerobic physical in nutritional skills). This meant that all multi-
activity or no physical activity. The agreement element interventions were assured a ‘floor’
level was 26/28 (93%), with a chance-corrected intensity score of at least 1. Constructing a score
Kappa coefficient (95% confidence interval) or 0.81 was achieved by simply adding 1 for presence or 0
(0.36, 1.00), indicating excellent agreement. for absence of the component. Overall (Table 3) no
association was observed between the intensity
score and the intervention’s effectiveness on
adiposity. When individual elements were ex-
Discussion plored, however, ‘compulsory’ provision emerged
as highly associated with effectiveness, and was
By applying a novel approach to synthesizing the found to have an excellent level of non-chance
results of the 28 controlled trials identified for agreement. On the basis of realism, this association
inclusion in this systematic review, one character- is here argued to be causal and rational. Causal
istic identified before synthesis and blind to out- because moderate to vigorous aerobic physical
come of the interventions emerged as being activity is biologically an effective means of body
associated with an effective outcome on one or fat reduction, and rational as the compulsory
more measure of adiposity. This characteristic is nature of this provision is very likely to ensure
the relatively compulsory nature of the provision of adherence.
aerobic physical activity. In the five trials that were Our findings support and explain those of
classified as ‘compulsory aerobic physical activity’, Thomas8 and the differential effectiveness by
five were classified as effective and none ineffec- gender points to the importance of tailoring the
tive concerning a measure of adiposity. Compulsory aerobic physical activity to gender-acceptable
provision in these trials was defined by more than varieties. On inspecting Table 3, the study by
one of the following: physical activity integrated Sallis16 seems to disconfirm the role of relatively
into the weekly curriculum; expected participation compulsory provision of physical activity.
in sessions with or without course credits; expected However, the amount of moderate-to-vigorous
participation in sessions with or without individual activity per week was only 13–16 min greater in
goals regarding measures of aerobic fitness; and the intervention group compared with the control
specification of moderate to vigorous physical group, and the physical activity required included
activity as aerobic activity rather than another muscle and bone strengthening, with aerobic
type (e.g. muscle strengthening). ‘Voluntary’ pro- activity being only one of three activities during
vision was characterized as more than one of the the 30-min session. Consequently, this study did not
following: encouragement to take part in demand a relatively high expenditure of aerobic
physical activity; provision of opportunities for activity.
such activities; possible inclusion of role modelling; Our approach to synthesis reported here is
and a specification of physical activity other than similar to other approaches. In particular,
aerobic. Pawson43 has attempted to apply realist concepts
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514 J.B. Connelly et al.

Table 3 Studies classified by effectiveness on adiposity and by study characteristics.

Characteristic Effective Ineffective

Number of Reference Number Reference number


studies number of studies

Age group (years)a


0–5.9 2 15, 22 2 38, 31
6.0–10.0 5 23, 26, 37, 39, 14 16, 19, 20, 21, 25,
40 27, 28, 30, 33, 34,
35, 36, 41, 42
11.0–13.9 4 17,18, 24, 29 0 –
14.0–17.0 0 – 1 32
Ethnicity
Caucasian 5 15, 18, 23, 26, 3 20, 27, 38
37
Caucasian and black or minority ethnic 3 17, 24, 29 5 16, 19, 25, 32, 34
group
African American 0 – 5 21, 28, 31, 35, 36
Native American 0 – 2 30, 33
Other 3 22, 39, 40 2 41, 42
Gender
Boys and girls 7 15, 18, 23, 26, 12 16, 19, 20, 25, 27,
37, 39, 40 30, 33, 34, 36, 38,
41, 42
Boys only 1 29 0 –
Girls only 3 17, 22, 24 5 21, 28, 31, 32, 35
Setting
Home only 0 – 1 33
Home and School (including pre-school) 3 18, 23, 26 2 30, 31
School only (including pre-school) 8 15, 17, 22, 24, 10 16, 19, 20, 25, 32,
29, 37, 39, 40 34, 36, 38, 41, 42
Clinic 0 – 0 –
Community/other 0 – 4 21, 28, 35, 27
Intervention
Nutrition education only 1 37 1 42
Nutrition education and nutritional skills 0 – 0 –
Physical education information (PE-I) only 1 15 0 –

Physical education information and 0 – 0 –


physical activity (PA-V) (voluntary)

Physical education Information and 1 22 1 16


physical activity (compulsory)
Nutrition education and physical education 5 17, 18, 29, 39, 0 –
Information and physical activity 40
(compulsory)
Nutrition education and nutrition skills and 1 26 12 19, 20, 21, 25, 27,
physical education information and 30, 31, 32, 34, 35,
physical activity (voluntary) 36, 41
Advice and skills for reducing television 2 23, 24 2 28, 38
viewing & PE-I & PA-V
Active parenting 0 – 1 33
Intervention score components
Theory or research based 7 17, 18, 22, 23, 13 16, 19, 20, 21, 23,
24 26, 40 28, 30, 31, 32, 34,
35, 36. 39
Researcher Implemented 4 17, 22, 39, 40 5 21, 31, 32, 34, 35
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Prevention childhood obesity and overweight 515

Table 3 (continued )

Characteristic Effective Ineffective

Number of Reference Number Reference number


studies number of studies

Compulsory physical activity 6 17, 18, 22, 29, 1 16


39, 40
Multi-component intervention 9 17, 18, 23, 24, 13 19, 20, 21, 25, 28,
26 27, 29, 39, 30 31, 32, 34, 35,
40 36, 38, 41
Quality score
0–4 0 – 0 –
5–9 2 15, 26 1 33
10–14 2 17, 29 4 16, 20, 36, 42
15–19 7 18, 22, 23, 24, 9 21, 25, 27, 30,
37 39, 40 31,34 35, 38, 41
20–24 0 – 3 19, 28, 32
25 and above 0 – 0 –
a
Age group contains the mean age of trial participants but age-group range may overlap.

to synthesis by incorporating earlier work on cing television viewing is supported by two


analytic induction within qualitative analysis ap- trials,23,24 and is shown ineffective by two
proaches. Although we are aware of these devel- trials.28,38 Consequently, this approach does not
opments, we have worked with our own warrant full support on current evidence. We
understanding of realism and epidemiology in this recommend that existing policies on physical
review, and have not used these alternative activity in schools be reviewed to emphasize the
approaches. The rigour of this study should be need for a compulsory level of moderate to
judged from the transparency of the methods for vigorous aerobic activity within the curriculum.
synthesis described and from our adherence to Further research should focus on the design and
established and accepted methods for identifying sustainability of compulsory aerobic physical activ-
and quality scoring studies. ity, its internalization as a voluntary behaviour and
We conclude the following: first, nutritional its durability across the life-course.
education, nutritional skills training and physical
education do not distinguish effective from inef-
Acknowledgements
fective interventions regarding reducing childhood
adiposity. However, compulsory rather than volun-
The authors thank Mrs Chris Stannard for preparing
tary aerobic physical activity does distinguish and,
the manuscript. JC was funded by the Berkshire
from a realist approach, may be rationally under-
Public Health Network.
stood as causally related to a decrease in adiposity
in children. Nutritional education and skills training
may reasonably be considered useful in a general
health promotion sense. Moreover, although not a Appendix A. Supplementary Material
necessary and sufficient component, nutritional
education and skills may be hypothesized to be a Supplementary data associated with this article can
necessary basis for compulsory physical activity to be found in the online version at doi:10.1016/
be effective. Here, we use a theory of component j.puhe.2006.11.015.
causation put forward by Kenneth Rothman.13
Against this hypothesis is the disconfirming trial
by Mo-Suwan,22 which showed an effect of compul-
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