European Journal of Cardiovascular Nursing (2022) 21, 26–35 ORIGINAL ARTICLE

doi:10.1093/eurjcn/zvab042

Nurse co-ordinated health and lifestyle

modification for reducing multiple cardio-
metabolic risk factors in regional adults:
outcomes from the MODERN randomized

Downloaded from https://academic.oup.com/eurjcn/article/21/1/26/6252466 by guest on 21 April 2024

controlled trial
Melinda J. Carrington1* and Paul Z. Zimmet2
1
Pre-Clinical Disease and Prevention Unit, Baker Heart and Diabetes Institute, 75 Commercial Road, Melbourne VIC 3004, Australia; and 2Department of Diabetes, Faculty of
Medicine, Nursing and Health Sciences, Monash University, 99 Commercial Road, Melbourne VIC 3004, Australia

Received 20 December 2020; accepted 16 March 2021; online publish-ahead-of-print 26 April 2021

Background Nurse-led health and lifestyle modification programmes can prevent cardio-metabolic diseases and be advantageous
where health disparities exist.
...................................................................................................................................................................................................
Aims To assess the effectiveness of a nurse-driven health and lifestyle modification programme in improving cardio-meta-
bolic risk parameters for higher-risk regional residing adults.
...................................................................................................................................................................................................
Methods We conducted an open, parallel-group randomized controlled trial in two sites. Participants were aged 40–70 years
with no prior cardiovascular disease who had any three or more of; central obesity, elevated triglycerides, reduced
high-density lipoprotein cholesterol, elevated blood pressure (BP) and dysglycaemia. Intervention participants
received individual face-to-face and telephone coaching for improving cardio-metabolic risk. Control group partici-
pants received standard care and general information about risk factor management. The primary endpoint was the
percentage of participants who achieved the target risk factor thresholds or clinically significant minimum changes
for any three or more cardio-metabolic risk factors during 24 months of follow-up.
...................................................................................................................................................................................................
Results Participant average age was 57.6 (SD 7.6) years, 61% were female and 71% were employed. The primary endpoint
was achieved by 76% intervention (97 of 127) and 71% usual care (92 of 129) participants [adjusted risk ratio (RR):
1.08; 95% CI 0.94, 1.24; P = 0.298]. Improved BP in the intervention group was more likely than in the control
group (84% vs. 65%) (adj. RR: 1.28; 95% CI 1.11, 1.48; P = 0.001) but no other cardio-metabolic component.
...................................................................................................................................................................................................
Conclusion Nurse intervention to modify cardio-metabolic risk parameters had no enhanced effectiveness compared with usual
care. However, participation was associated with improvements in cardio-metabolic abnormalities, with particular
emphasis on BP.
...................................................................................................................................................................................................
Trial Registered with the Australian New Zealand Clinical Trial Registry (ACTRN12616000229471).
Registration
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Keywords Nurse intervention • Randomized controlled trial • Primary prevention • Risk factors • Cardio-metabolic
disease • Cardiovascular disease

* Corresponding author. Tel: þ61 3 8532 1638, Fax: þ61 3 8532 1100; Email: melinda.carrington@baker.edu.au
C The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.
Published on behalf of the European Society of Cardiology. All rights reserved. V
Outcomes from the MODERN randomized controlled trial
Implications for practice
• A more intense nurse-led, healthy lifestyle modification intervention is not essential to reduce cardio-metabolic risk compared with
enhanced usual care.
• There remains a key role for nurses to facilitate cardio-metabolic risk factor management in higher-risk communities.
• Targeting adults with elevated levels of multiple risk factors is necessary for preventing the onset of cardio-metabolic disease.
• Risk factor assessment and routine follow-up that can be completed by nurses can assist individuals to achieve ideal target levels and revert
cardio-metabolic risk.
..
Introduction
More people die from cardiovascular disease (CVD), predomin-
antly ischaemic heart disease, than any other cause in Australia in
2018.1 Mortality from CVD has been significantly reduced since
the late 1960s peak and this has been replicated globally owing to
the success of a number of factors including; better detection,
prevention (e.g. decline in smoking rates), treatment following the
advancement of new therapeutics (e.g. stents to treat myocardial
infarction) and medications to manage risk factors (e.g. statins),
and public health campaigns.2 It follows that CVD is the most ex-
pensive disease group to treat and remains to be a significant bur-
den of disease. Therefore, efforts to combat CVD are ongoing
and required.Improving major risk factors for the development of
CVD, including its key predecessor, type 2 diabetes (T2D), is one
opportunity to reduce the burden from CVD. Prevalence statis-
tics of cardiovascular risk factors are high and expose an enduring
health problem. In the latest 2011–12 Australian Health Survey,
two-thirds of people aged 18 or above had three or more
co-existing risk factors for chronic disease.3 Subgroups of the
population living in regional and remote areas and from lower
socioeconomic groups were more likely to have multiple risk fac-
tors, impacting on higher CVD and diabetes risk, hospitalization
rates, deaths, and burden caused by CVD. In Europe, similar
observations have been reported4,5 and in the latest
EUROASPIRE V survey, large proportions of the population
without a history of CVD but initiated on preventative pharma-
cological treatment had inadequate risk factor control and un-
healthy lifestyles.6 Identifying individuals with clusters of risk
factors denoted by the metabolic syndrome (MetS)7 and provid-
ing appropriate risk factor management is important to prevent
CVD8 and T2D9 onset. Metabolic syndrome is represented by
any three or more of obesity, hypertension, dyslipidaemia [ele-
vated triglycerides or reduced high-density lipoprotein choles-
terol (HDL-C)], or dysglycaemia.
Healthy lifestyle interventions have enhanced effectiveness for
reversing MetS10 with some evidence of reducing the onset of
T2D in the short term11 and added benefit of being delivered by
nurses.12,13 Therefore, our aim was to assess the effectiveness of a
nurse-driven health and lifestyle modification programme in
improving cardio-metabolic risk parameters for higher-risk re-
gional residing adults with MetS but without CVD. It was hypothe-
sized that there would be more adults in the intervention group
compared with standard care who achieve the primary endpoint
of meeting target risk factor thresholds or clinically significant
27
.. minimum changes for at least three risk factors of the MetS over
.. 24 months of follow-up.
..
..
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..
.. Methods
..
..
... Study design
.. MODERN was an open, parallel-group randomized controlled trial
.. (RCT) comparing a nurse-led health and lifestyle modification pro-
.. gramme (intervention group) with standard care (control group) in re-
..
.. gional adults aged 40–70 years who had MetS. Consistent with the
.. MODERN study protocol,14 non-invasive clinical examinations and con-
..
.. sultations were held in two nurse operated clinics that were established
.. in regional Victoria, Australia. Both clinics were involved with each arm of
.. the study and four nurses (two per clinic) shared participants from both
..
.. groups. A cluster randomized trial was not preferred since there were
.. not a sufficient number of clusters and to avoid confounding in sociode-
..
.. mographic factors across treatment groups. Recruitment began on 26
.. September 2014 and was completed on 1 April 2016 across the two
.. clinics. The last participant was randomized on 30 March 2016 and final
..
.. follow-up was completed on 20 February 2018. The study was
.. approved by the Australian Catholic University Human Research
..
.. Ethics Committee (Project No: 2014 244 V) and conforms with the
.. principles outlined in the Declaration of Helsinki. All participants pro-
.. vided written informed consent to be involved; the consent process
..
.. was undertaken by the study nurse upon enrolment in the clinic at the
.. screening assessment visit.
..
..
.. Study population
..
.. All study participants had MetS, as determined by clinical assessment, and
.. were recruited by screening self-selected individuals who volunteered to
.. participate in response to advertising and community and workplace pro-
..
.. motion of the study. Screening for study eligibility was according to the
.. following inclusion criteria: (i) aged between 40 and 70 years; (ii) any
..
.. three or more risk factors for MetS7 comprising central obesity (men
.. >94 cm; women >80 cm), elevated triglycerides (>_1.7 mmol/L),
.. reduced HDL-C (men <1.03 mmol/L; women <1.29 mmol/L), elevated
..
.. blood pressure (BP, >_130/85 mmHg), and dysglycaemia (glycated
.. haemoglobin, HbA1C >_5.7%); (iii) no self-reported previously diag-
..
.. nosed CVD or other chronic disease; and (iv) residing in Colac or
.. Shepparton in the state of Victoria, Australia. Criteria for exclusion
.. were younger than 40 years or older than 70 years of age, two or
..
.. fewer risk factors that characterize the MetS, a pre-existing diagnosis
.. of CVD, chronic kidney disease or other chronic disease that would af-
..
.. fect participation, neurological/cognitive impairment, or were not local
.. residents to the communities.
..
..
.. Randomization
.. For each nurse clinic, a computer generated (using IBMV SPSS Statistics
R
..
. v19), sequentially numbered randomization list was developed in advance
28 M.J. Carrington and P.Z. Zimmet

by the Chief Investigator (M.J.C.). Block randomization (block size 20)

.. Via wearable monitors
..
with stratification for established T2D was applied at a 1:1 ratio to allo- ..
cate participants to either nurse intervention or standard care.15 Blinding
.. (4) Physical activity and sedentary behaviour—with 7-day continuous actig-
.. raphy monitoring using GTX3 accelerometers (ActiGraph, FL,
study group allocation to either the participants or nurses was not pos- ..
sible due to the study design. .. USA).
... Via a screening assessment
..
Study endpoints ..
The primary endpoint was the percentage of participants who achieved
.. (5) Physical measurements of biomedical risk factors including—body
.. weight, sitting BP after 5 min rest using an automated BP monitor
the target risk factor thresholds or clinically significant minimum changes ..
for any three or more components of the MetS, according to Table 1,
.. (Omron HEM-907, Omron Healthcare Co. Ltd, Kyoto, Japan), and
.. fasting (minimum 8 h) blood lipids and blood glucose using a point
during 24 months of follow-up. .. of care analyser (AfinionTM AS100, Alere, MA, USA). Two BP read-
Each MetS parameter of the primary endpoint was also assessed separ- ..
.. ings were taken separated by a 1 min break and the average was
ately in secondary outcome analyses. Other secondary endpoints .. analysed; however, if the difference between BP readings was >_10/
included biomedical risk factors contributing to cardio-metabolic disease, ..
.. >_5 mmHg, a 3rd measurement was taken and the closest two were

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health and lifestyle behaviours, and subjective health. We further exam- .. analysed. The applicable health determinants were used to calcu-
ined resolution of MetS status, incidence of T2D and CVD, and pharma- ..
.. late CVD risk using the Framingham risk prediction model17 and
cological therapy measured at baseline and 24 months. .. T2D risk using the Australian risk assessment (AUSDRISK)18 5-
..
.. year tools according to national guidelines.
Study procedures and data ..
As specified in the MODERN study protocol,14 at baseline and at each .. To standardize the intervention and ensure treatment fidelity across
.. conditions, the study (i) was conducted in accordance with a written proto-
annual visit (12 and 24 months), all study participants completed a self- ..
report questionnaire and underwent a physical examination. Registered .. col; (ii) nurses were trained by the lead Investigator (Carrington) with over
.. 10 years of experience in cardio-metabolic risk assessment and by an
nurses applied standardized procedures based on expert guidelines for all ..
clinical assessments. Data acquisition processes and type of information .. accredited external provider in motivational interviewing; (iii) a standard set
.. of educational resources was used; (iv) clinic visit interactions (two per
collected included: .. study arm for each nurse at baseline and 12 months of follow-up) were vid-
Via questionnaire ..
.. eotaped, reviewed by an independent assessor, and structured feedback
(1) Sociodemographic information—age, sex, ethnicity, relationship status,
.. was provided; and (v) participant attendance at clinic visits were collected.
..
employment, and education level. ..
(2) Health and lifestyle behaviours—smoking; diet and alcohol via the .. Study intervention
..
Dietary Questionnaire for Epidemiological Studies (DQES v2), with .. Based on the screening assessments, participants in the intervention
calculation of a diet quality score via the Australian Recommended .. group were given individual face-to-face and telephone coaching by the
..
Food Score (higher scores, from a maximum of 74, denote higher .. same nurse to achieve the goals of the health and lifestyle intervention.
diet quality).16 .. Registered nurses were experienced in community health or were cre-
(3) General health—medications; medical history; family history of
.. dentialed Diabetes Educators. These participants received the results
..
CVD; and diabetes. . of their screening assessment and MetS status followed by: (i) cardio-

Table 1 Criteria for target risk factor thresholds and minimum change in components of metabolic syndrome to
assess the primary endpoint

MetS parameters Sex Target Clinically significant minimum

changea
....................................................................................................................................................................................................................
Elevated WC Men <94 cm Reduce by >_5 cm
Women <80 cm Reduce by >_6 cm
Elevated triglycerides Men <1.7 mmol/L Reduce by >_0.6 mmol/L
Women Reduce by >_0.5 mmol/L
Reduced HDL-C Men >_1.03 mmol/L Increase by >_0.15 mmol/L
Women >_1.29 mmol/L Increase by >_0.18 mmol/L
Elevated BP Men <130/85 mmHg Reduce by >_7/3 mmHg
Women Reduce by >_8/4 mmHg
Elevated HbA1C Men <5.7% (39 mmol/L) Reduce by >_0.4%
Women Reduce by >_0.5%

BP, blood pressure; HbA1C, glycated haemoglobin; HDL-C, high-density lipoprotein cholesterol; MetS, metabolic syndrome; WC, waist circumference.
a
Represents >0.5 standard deviation change from baseline using pilot data in adults with MetS20.
Outcomes from the MODERN randomized controlled trial
..
metabolic risk factor management, (ii) health education and advice, (iii)
care planning, and (iv) scheduled follow-up. In addition to 12 and
24 months of follow-up visits, each participant in the intervention group
had a number of required visits depending on their risk level, as denoted
by the GARDIAN traffic-light management system.19 If, at any study visit a
nurse discovered a clinical problem that required attention, the partici-
pant was advised to contact their general practitioner (GP) for review. A
detailed description of the intervention is in the published protocol.14
Control group
Participants in the control group were given a written summary of their
screening assessment results and MetS status and received general risk
factor information by the same nurse at baseline and subsequent annual
(12 and 24 months) visits. Individualized health education and advice, care
planning, and scheduled follow-up according to GARDIAN status were
not followed to guide management. These participants could contact
their GP or seek any other relevant concomitant care for treatment and
follow-up.
Statistical analysis
Using findings from a similar trial11 and our pilot intervention study,20 we
predicted a 15% absolute difference (20% intervention, 5% control) in
the percentage of participants who achieved the target risk factor thresh-
olds or clinically significant minimum changes for at least three compo-
nents of the MetS during 24 months of follow-up. We estimated that 125
participants per study arm (enrolling 150 participants per group account-
ing for 15% attrition) at a two-sided a = 0.05 would provide 95% power
to detect a 0.15 difference in the primary endpoint after 24 months of
follow-up.
Intention to treat statistical analyses were completed by an independ-
ent bio-statistician according to a prospectively developed statistical ana-
lysis plan and using the Stata statistical software v15 (StataCorp, College
Station, TX, USA). Tests were two-sided at the nominal level a = 0.05.
Continuous variables were expressed as mean ± standard deviations or
medians with interquartile ranges. Differences between baseline and
post-test in the variable values were compared within each group using
paired t-test and between-group differences of the change in variable val-
ues were compared using Student’s t-tests or Mann–Whitney U tests for
variables with skewed distributions. Discrete variables were assessed by
frequencies and percentages and group differences tested using v2 tests
with calculation of relative risk and 95% CI. The primary endpoint meas-
ured at 24 months was treated as a binary variable and analyses were
based on the treatment group to which the participant was randomized.
Between-group comparisons of the primary and secondary endpoints
was performed using a log binomial generalized linear model, accounting
for stratification factors (clinic location and established T2D) at random-
ization and change in medication (BP lowering, lipid lowering, or glucose
lowering) from baseline to 24 months of follow-up. Predictors of (pri-
mary and secondary) endpoint achievement were evaluated with boot-
strapped aggregation of stepwise logistic regression to get an initial set
of potential predictor variables, followed by backwards elimination
robust Poisson regression (note: these analyses were judged to be
non-informative).
Results
Figure 1 shows the study CONSORT flow chart. Of 853 individuals
assessed for study eligibility, the majority (n = 567) were excluded for
not demonstrating features of the MetS and 276 (32%) who fulfilled
the criteria for MetS and who consented to participate were
29
.. randomized. There were 17 individuals (intervention group, n = 6;
.. usual care group, n = 11) who were not exposed to any allocated
..
.. intervention and were subsequently excluded from future analyses.
.. Following randomization and after intervention exposure, three indi-
..
.. viduals in the intervention group either had no data (n = 2) or incom-
.. plete data (n = 1) available and were excluded from endpoint
..
.. analyses. The full analysis set included 256 participants; 127 nurse-led
..
.. intervention and 129 usual care.
..
..
.. Baseline risk profiles
.. Table 2 shows the baseline sociodemographic, clinical characteristics,
..
.. health behaviours, and prescribed medicines for early intervention of
.. cardio-metabolic health of the two study groups. Participants were
..
.. well matched between groups. Individuals were predominantly of
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.. European origin (97%) with an average age of 57.6 (SD 7.6) years.
..
.. Just over half (61%) were female and more than two-thirds (71%)
.. remained employed (63% full-time or part-time employment).
..
.. Individuals in the usual care group had more obesity, reflected by
..
.. higher BMI scores (32.5 kg/m2 vs. 30.9 kg/m2, P = 0.020) and increased
.. waist circumference (106 cm vs. 102 cm, P = 0.017), otherwise no sig-
..
.. nificant differences were evident at baseline between groups for any
.. variable.
..
..
.. Change in risk factors
..
.. Apart from physical activity and sedentary behaviour, there were
.. improvements in all risk factors for participants in both the interven-
..
.. tion and usual care groups during study follow-up (Table 3). Within-
.. group (paired) differences in BP, body weight, lipids, HbA , CVD
.. 1C
.. risk, and energy from consuming food were significantly reduced in
..
.. both groups from baseline to 24 months (all P < 0.05). In each group,
.. HDL-C, and total diet (ARFS) scores significantly increased (P < 0.05)
..
.. reflecting improved risk factor control. To the contrary, steps per
.. day significantly decreased in the intervention (P < 0.001) and usual
..
.. care groups (P = 0.007) alongside increased sitting time and reduced
.. moderate-to-vigorous physical activity, which were not statistically
..
.. significant in both groups. As indicated in Table 3, the between-group
.. changes at 24 months were significant for BP, which was reduced by
..
.. an average difference of 7 (95% CI 10 to 3)/3 (95% CI 5 to
..
.. 1) mmHg and CVD risk by a median of differences of 1 (95% CI
.. 2 to 0) in the intervention group when compared with the usual
..
.. care group. There were no other group differences at study end for
.. any variable.
..
.. Smoking prevalence decreased in both groups at 24 months from
.. 12 to 8 smokers in the intervention group (5 quit smoking, 1 started
..
.. smoking, and 7 remained current smokers) and from 14 to 12 smok-
.. ers in the usual care group (2 quit smoking) with no evidence of a dif-
..
.. ference in rates of smoking between groups at 24 months [risk ratio
.. (RR): 0.68; 95% CI 0.29, 1.61]. Rates of high-risk alcohol consumption
..
.. >2 drinks on any day remained similar within and between groups
..
.. after 24 months of follow-up (25% intervention vs. 26% usual care,
.. RR 0.96; 95% CI 0.63, 1.47)—data not shown.
..
.. For participants in the nurse intervention group, 20 (16%) were
.. designated as amber (intermediate) risk at baseline and 35 (28%) at
..
.. 24 months while there were 107 (84%) red (high) risk coded individ-
.. uals at baseline and 92 (72%) at 24 months. The proportion of
..
. GARDIAN directed clinic visits, which were attended as per protocol
30 M.J. Carrington and P.Z. Zimmet

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Figure 1 MODERN study CONSORT flow chart.

up to 24 months of follow-up was 93% for amber designated partici-

.. of meeting the endpoint for all other MetS components was compar-
..
pants (maximum of 4 visits over 24 months) and 89% for red desig- .. able between the intervention and usual care groups, respectively,
..
nated individuals (maximum of 6 visits over 24 months). .. for waist circumference (35% vs. 26%, adj. RR 1.30; 95% CI 0.90, 1.90;
.. P = 0.165), triglyceride (60% vs. 66%, adj. RR 0.90; 95% CI 0.75, 1.09;
..
Primary endpoint .. P = 0.287), HDL-C (87% vs. 88%, adj. RR 0.99; 95% CI 0.91, 1.09;
During 24 months of follow-up, the percentage of participants who .. P = 0.889), and HbA1C (61% vs. 67%, adj. RR 0.91; 95% CI 0.76, 1.09;
..
achieved the target risk factor thresholds or clinically significant min- .. P = 0.910). It follows that the likelihood of maintaining MetS status at
imum changes for any three or more components of the MetS was
.. 24 months for participants in the intervention group was reduced
..
76% (97 of 127) in the intervention group compared with 71% (92 of .. compared with the usual care group (44% vs. 51%) but this difference
..
129) in the usual care group (adjusted RR: 1.08; 95% CI 0.94, 1.24; .. was not significant (adj. RR 0.87; 95% CI 0.61, 1.25; P = 0.475).
P = 0.298). .. There were three participants in the intervention group and two
..
.. participants in the usual care group who were initiated on glucose-
Secondary endpoints .. lowering medication during 24 months of follow-up. Another five
..
Achievement of the target threshold or clinically significant minimum .. individuals in the usual care group and none in the intervention group
change for BP in the intervention group (106 of 127; 84%) was more .. had an HbA1C level >_6.5% indicative of diabetes21 but without evi-
..
likely compared with the usual care group (84 of 129; 65%) (adj. RR: .. dence of pharmacological therapy or any prior history of
1.28; 95% CI 1.11, 1.48; P = 0.001). The difference in the probability
.. T2D. Overall, there was a reduced but non-significant risk of incident
Outcomes from the MODERN randomized controlled trial 31

Table 2 Baseline demographic and clinical characteristics for each study group

Intervention group (N 5 127) Control group (N 5 129)

....................................................................................................................................................................................................................
Age [years; mean (SD)] 57.9 (8.0) 57.2 (7.1)
Sex [female; n (%)] 83 (65) 73 (57)
Sociodemographic profile
Marital status [married/de facto; n (%)] 92 (72) 93 (72)
Ethnicity [European origin; n (%)] 120 (95) 127 (98)
Employment [employed; n (%)] 88 (69) 93 (72)
Education [higher education; n (%)] 53 (42) 56 (43)
Clinical characteristics
Blood pressure
Systolic [mmHg; mean (SD)] 137 (17) 135 (13)

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Diastolic [mmHg; mean (SD)] 81 (10) 82 (9)
Body weight
BMI [kg/m2; mean (SD)] 30.9 (5.4) 32.5 (5.5)*
Waist circumference [cm; mean (SD)] 102.2 (12.9) 106.0 (12.4)*
Lipid profile
Total cholesterol [mmol/L; mean (SD)] 5.84 (1.26) 5.67 (1.19)
LDL-C [mmol/L; mean (SD)]a 3.36 (1.09) 3.25 (1.01)
HDL-C [mmol/L; mean (SD)] 1.48 (0.41) 1.47 (0.42)
Triglyceride [mmol/L; mean (SD)] 2.33 (1.22) 2.29 (1.21)
HbA1C [%; mean (SD)] 5.79 (0.60) 5.89 (0.79)
Cardiovascular risk score
Low [n (%)] 96 (76) 101 (78)
Moderate [n (%)] 24 (19) 21 (16)
High [n (%)] 7 (5) 7 (5)
Diabetes (type 1 or type 2) 9 (7) 10 (8)
Family history
Cardiovascular disease [n (%)] 35 (28) 40 (31)
Diabetes [n (%)] 26 (21) 23 (18)
Health behaviours
Smoking [current; n (%)] 12 (9) 14 (11)
Alcohol [>2 std drinks on any day; n (%)] 38 (30) 34 (26)
Dietb
Energy [kJ/day; mean (SD)] 7679 (3763) 8188 (3467)
Australian Recommended Food Score [mean (SD)] 29.3 (9.5) 30.8 (8.9)
Physical activity/sedentary behaviourc
Steps count [mean (SD)] 13 588 (4642) 13 355 (4932)
Sedentary time [min/day; mean (SD)] 571 (91) 582 (95)
Moderate-to-vigorous intensity [min/day; median (IQR)] 23 (11–44) 26 (14–39)
Pharmacotherapy
Anti-hypertensive [n (%)] 49 (39) 41 (32)
Lipid lowering [n (%)] 27 (21) 22 (17)
Hypoglycaemic [n (%)] 5 (4) 8 (6)

*P < 0.05.
HbA1C, glycated haemoglobin; HDL-C, high-density lipoprotein cholesterol; IQR, interquartile range; LDL-C, low-density lipoprotein cholesterol.
a
Nurse Intervention group (n = 124); Usual Care group (N = 127).
b
Nurse Intervention group (n = 126).
c
Nurse Intervention group (n = 98); Usual Care group (N = 97).

T2D in the intervention group (2.4%) relative to usual care (5.4%)

.. for two participants in the nurse intervention and two people in
..
(adj. RR 0.44; 95% CI 0.12, 1.65; P = 0.223). Incident CVD, evidenced .. the usual care group (one case of each procedure in both groups,
by stenting or coronary artery bypass grafting procedures occurred
.. all male).
..
.
 32

Table 3 Comparison of changes in health behaviours and clinical characteristics within each study group and between groups at 24 months

Intervention group (N 5 127) Control group (N 5 129)

............................................................................................ ..................................................................................................
a
N Before After Difference P N Before After Difference P P
................................................................................................................................................................................................................................................................................................
Clinical characteristics
Blood pressure
Systolic (mmHg) 127 137 (17) 127 (12) 10 (13, 8) <0.001 129 135 (13) 132 (15) 4 (6, 1) 0.003 <0.001
Diastolic (mmHg) 127 81 (10) 77 (9) 4 (6, 3) <0.001 129 82 (9) 80 (11) 2 (3, 0.2) 0.030 0.010
Body weight
BMI (kg/m2) 127 30.9 (5.4) 30.5 (5.5) 0.4 (0.7, 0.1) 0.024 129 32.5 (5.5) 32.0 (5.5) 0.4 (0.9, 0.02) 0.041 0.860
Waist circumference (cm) 127 102.2 (12.9) 98.6 (13.4) 3.6 (4.7, 2.5) <0.001 129 106.0 (12.4) 103.3 (11.9) 2.7 (3.9, 1.5) <0.001 0.289
Lipid profile
Total cholesterol (mmol/L) 126 5.83 (1.26) 5.28 (1.07) 0.56 (0.77, 0.34) <0.001 129 5.67 (1.19) 5.29 (1.08) 0.38 (0.56, 0.21) <0.001 0.222
LDL-C (mmol/L) 124 3.36 (1.09) 2.90 (0.90) 0.45 (0.63, 0.26) <0.001 127 3.25 (1.01) 2.97 (0.96) 0.28 (0.44, 0.13) <0.001 0.177
HDL-C (mmol/L) 127 1.48 (0.41) 1.53 (0.39) 0.05 (0.004,0.10) 0.033 129 1.47 (0.42) 1.54 (0.39) 0.07 (0.03,0.11) 0.002 0.563
Triglyceride (mmol/L) 127 2.33 (1.22) 1.96 (1.09) 0.37 (0.59, 0.16) 0.001 129 2.29 (1.21) 1.93 (1.21) 0.36 (0.60, 0.11) 0.004 0.930
HbA1C (%) 127 5.79 (0.60) 5.67 (0.47) 0.12 (0.18, 0.07) <0.001 129 5.89 (0.79) 5.74 (0.74) 0.16 (0.21, 0.10) <0.001 0.410
Cardiovascular risk score [%; median (IQR)] 126 5 (3–9) 4 (3–6) 1 (2, 0) <0.001 129 5 (3–9) 5 (3–8) 0 (2, 1) 0.011 0.007
Health behaviours
Diet
Energy (kJ/day) 123 7645 (3786) 6762 (3310) 883 (1349, 418) <0.001 122 8242 (3529) 7358 (3063) 884 (1438, 330) 0.002 0.999
Australian Recommended Food Score 123 29.4 (9.5) 31.8 (9.9) 2.4 (1.1,3.7) <0.001 122 30.5 (8.7) 31.9 (9.4) 1.3 (0.1,2.5) 0.030 0.238
Physical activity/sedentary behaviour
Steps count 78 13 855 (4646) 12241 (4234) 1614 (2363, 865) <0.001 70 12 987 (4654) 11937 (4478) 1050 (1806, 295) 0.007 0.294
Sedentary time (min/day) 78 572 (88) 589 (90) 17 (1, 34) 0.069 70 596 (90) 597 (93) 1 (16, 18) 0.903 0.211
Moderate-to-vigorous intensity [min/day; median (IQR)] 78 23 (15–39) 26 (11–37) 2 (12, 8) 0.247 70 26 (12–38) 17 (8–38) 2 (13, 5) 0.063 0.529

All data are mean (SD) unless indicated.

HbA1C, glycated haemoglobin; HDL-C, high-density lipoprotein cholesterol; IQR, interquartile range; LDL-C, low-density lipoprotein cholesterol.
a
P-values of absolute difference (end of trial minus baseline) in variable values between the intervention and control group.
M.J. Carrington and P.Z. Zimmet

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Outcomes from the MODERN randomized controlled trial 33

..
Change in medical care .. However, usual care could have been enhanced by nurses who might
.. also have acted as instigators of change. On the contrary, our findings
Pharmacological treatment for BP lowering was modified for 12 ..
(10%) participants in the nurse intervention group (9 who were initi- .. may indicate that the multi-factorial intervention strategy that was
.. not designed to focus on one risk behaviour, was too weak and wide-
ated on treatment and 3 who had a class added) and for 12 (9%) par- ..
ticipants in the usual care group (11 initiated on treatment and 1 had .. ranging. Distinct interventional aspects, such as supervised exercise,
.. prescriptive diet plans or personalized treatment targets for individu-
a class addition). Therapy was started for lipid lowering in 12 (10%) ..
and 6 (5%) individuals in the intervention and usual care groups, re- .. als (e.g. percentage reduction of weight loss) may have been more ef-
..
spectively (RR 2.05; 95% CI 0.79, 5.29). Overall, there was no differ- .. fective, as evidenced by the results of major clinical trials on the
ence in the modification of pharmacological therapy between groups .. reduced incidence of diabetes in association with changes in life-
..
for either BP-, lipid-, or glucose-lowering treatments at 24 months .. style.25,26 Our intervention was led by researcher nurses using motiv-
(18% vs. 15%, RR 1.24; 95% CI 0.71, 2.16).
.. ational interviewing and behavioural counselling to help stimulate
..
.. behaviour change14; this may be better achieved by other health pro-
.. fessionals who are more specially trained (e.g. psychologists) and may
..
Discussion ..

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induce greater improvements. Caution needs to be exercised when
.. comparing evidence of benefit though due to complications caused
In this pragmatic RCT to modify cardio-metabolic risk parameters, ..
.. by significant heterogeneity in study designs. This is amid an extreme-
we observed improvements across multiple risk factors for CVD and .. ly broad array of modalities of health and lifestyle modification pro-
T2D in a regional population over 24 months of follow-up, which
..
.. grammes in terms of follow-up duration, delivery (e.g. nurses, health
were applicable to individuals from both groups. Hence, contrary to ..
our hypothesis, our findings demonstrated no enhanced effectiveness
.. professionals), content (e.g. diet, physical activity), format (e.g. group
.. or individual), mode (e.g. telephone, face-to-face), frequency/intensity
of a nurse-facilitated health and lifestyle modification programme ..
over usual care in achieving the primary endpoint. An exception was
.. (weekly, monthly), and others.
.. Our findings, albeit relatively small in magnitude, provided evi-
BP, which showed that participants who received nurse intervention ..
.. dence that leadership by nurses for multiple risk factor management
had 1.28 times the risk of a clinically significant improvement com- ..
.. had some positive effect. There was greater success in efforts to fa-
pared with people who received standard care. This result empha-
.. vourably alter diet quality, but more limited success in changing life-
sizes the importance of effective management of elevated BP and is .. style behaviours towards greater physical activity and less sedentary
consistent with findings facilitated by nurses in other settings.22 ..
.. time. Enhancement or maintenance of physical activity may have
Other studies in primary prevention of cardio-metabolic disease .. been more difficult to uphold across years of follow-up and more ef-
using lifestyle interventions have shown significant group differences. ..
.. fort or readiness for change may have been placed on other behav-
In one RCT in rural Australia, improvements in cardio-metabolic risk ..
parameters were demonstrated as a result of a home-based dietary .. iours relative to physical activity. Despite not reaching statistical
.. significance between groups for any variable other than BP (average
and physical activity programme over 6 months using print materials ..
and an online programme with routine telephone follow-up.23 In two .. decrease of 10/4 mmHg), our nurse intervention induced modest
.. reductions in body weight (decrease of 0.4 kg/m2 in BMI and 3.6 cm in
studies in primary healthcare, a more intensive lifestyle intervention ..
entailing individualized diet and physical activity recommendations .. waist circumference), lipids (decrease of 0.56 mmol/L in total choles-
.. terol; 0.45 mmol/L in low-density lipoprotein cholesterol (LDL-C);
led by trained professionals showed improvements after 1 year of ..
follow-up.11 Group sessions conducted by nurses based on diet and
.. and 0.37 mmol/L in triglyceride; increase of 0.05 mmol/L in HDL-C),
.. and HbA1C levels (0.12% decrease). This enabled more people to
physical activity as part of the Greater Green Triangle Diabetes ..
Prevention Program also revealed reductions in risk factors in rural
.. achieve risk factor targets, recover from MetS status, and contribute
..
adults in a pre-test and 1 year post-test intervention study.24 These .. to greater reductions in overall CVD risk scores (1% decrease).
studies attest to the effectiveness of nurse-led lifestyle interventions
.. These results were sustained for at least 24 months and at minimum,
..
and are further supported by meta-analyses that report an overall .. were analogous to those reported in other RCTs that examined risk
.. management via nurse intervention in CVD patients.27,28 Compared
pattern of positive effects of nurse intervention compared with usual ..
care of varying magnitudes for most, but not all risk factors.12,13 .. with the renowned COACH programme over 6 months, our results
.. in the intervention group were better for BP (no change in
Our inability to show any group differences was more likely caused ..
by the trial been underpowered because of the response in the usual .. COACH), total cholesterol (0.54 mmol/L reduction), and triglyceride
.. levels (0.17 mmol/L reduction) but not as favourable for BMI
care group being unexpectedly favourable. Notably, frequencies of ..
the endpoints were equally high in both study groups. This may sug- .. (0.5 kg/m2 decrease), LDL-C (0.55 mmol/L decrease), and HDL-C
..
gest that participants in the usual care arm were motivated to modify .. (0.08 mmol/L increase).27 Our results in the intervention group were
their behaviour (the well-known Hawthorne effect) and GPs may .. also more effective compared with two meta-analyses of nurse-led
..
have been more reactive. Whether this response was causal of par- .. studies in adults with diabetes and chronic disease.12,13
ticipation in the trial or occurred naturally as a result of standard care .. The impact of achievable improvements in reducing cardio-meta-
..
is not known. Nurse involvement in both groups occurred with the .. bolic risk has clinical implications. Our strategy showed that reducing
intention that participants allocated to the usual care group still .. BP largely influenced reversion of MetS status in participants assigned
..
received a more basic screening assessment and results only, without .. to the intervention. Whilst ‘MetS’ may be perceived to be an old fash-
any supplementary intensification of management by nurses, which
.. ioned term, the clustering of component risk factors predispose the
..
was preserved for participants assigned to the intervention group. . development of CVD and T2D.8,9 A recent nation-wide cohort study
34 M.J. Carrington and P.Z. Zimmet

..
of approximately 10 million people showed that recovery from MetS ..
significantly decreased risk for major adverse cardiovascular events.29 ..
..
In this study, among all MetS components, a decrease in BP was ac- ..
countable for the risk reduction. This highlights the importance of ..
..
reducing elevated BP and corresponds with clinical trial findings of ..
the effectiveness of BP lowering at higher BP levels and for higher-
..
..
risk individuals with a history of CVD.30 Yet small population-wide
decreases of 1 or 2 mmHg in systolic BP (SBP) and diastolic BP (DBP)
were predicted to substantially reduce CVD incidence from the
Framingham Heart Study31 and Atherosclerosis Risk in Communities
Study.32 Mapping our reduction in SBP of 10 mmHg and DBP of
4 mmHg seen in the intervention group contrasts with an estimated
number of avoidable events of 10 (in participants with lower risk)
claims information about accessing medical services and prescription
medicines. As previously mentioned, the individual randomization de-
sign was a limitation such that nurses were not blinded to study group
allocation and their engagement with participants in both groups may
have compromised the risk of intervention contamination. Providing
a summary of results to participants in the usual care group was not
.. common practice and may have had an enhancing influence.
..
.. In conclusion, we have shown in this pragmatic RCT to modify car-
.. dio-metabolic risk parameters that the nurse-facilitated health and
..
.. lifestyle modification programme being tested had no effect in com-
.. parison to usual care. The MODERN programme overall allowed
..
.. nearly two-thirds of all participants to make clinically significant
.. improvements in several metabolic abnormalities, with particular
..
..

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and 37 (in higher-risk individuals) for SBP, and 11 and 41, respectively, emphasis on BP, highlighting the value of targeting adults who may re-
for DBP.33 Similarly, the 5-year benefits of lowering LDL-C by
..
.. ceive benefit from management of elevated risk factors for cardio-
1.0 mmol/L is associated with 6–61 avoidable events, in lower- and .. metabolic disease. Further research to explore different approaches
higher-risk groups, respectively.34 If these estimates are reliable, they
..
.. for attempting to modify behaviour with greater influence on diet
affirm that even slight changes that we observed in risk factor levels .. and lifestyle modification are needed to counteract the cascade of ad-
..
have prognostic significance. .. verse impacts caused by excess cardio-metabolic disease risk that
It is unknown as yet whether the benefits of risk factor reductions .. continue to plague our healthcare system today.
..
that we found would be maintained long term to prevent or delay ..
the development of CVD and T2D. In one study of patients attending ..
..
primary care, the benefit of lifestyle modification achieved remission .. Acknowledgements
of T2D after 12 months35 and in the Diabetes Prevention Program .. We gratefully acknowledge the nurses for carrying out the interven-
..
Outcomes Study, regression to normal glucose regulation, even if .. tion and the research administrative team for providing study sup-
transient, significantly reduced risk of future T2D over a median 5.7
.. port. Appreciation to Dr Andre Rodrigues for actively facilitating
..
years.36 On the contrary, a Cochrane review to assess multiple risk .. participant recruitment and Prof. Adrian Esterman for undertaking
factor interventions using counselling or educational approaches for
..
.. statistical analyses. The authors thank Prof. Graham Giles of the
primary prevention of CVD reported only small effects that had lim- .. Cancer Epidemiology Centre of The Cancer Council Victoria, for
..
ited long-term impact on CVD mortality and morbidity.37 On this .. permission to use the Dietary Questionnaire for Epidemiological
basis, it was recommended that more minimalistic interventions that .. Studies (Version 2), Melbourne: The Cancer Council Victoria, 1996.
..
entail health professional advice alone be reserved for higher-risk ..
patients with existing CVD and elevated levels of risk factors who .. Funding
.. M.J.C. is supported by a Future Leader Fellowship (Award Reference
stand more to gain from behaviour change and longer-term risk ..
reduction.37
.. 100802) from the National Heart Foundation of Australia. The
.. MODERN trial was funded by a Project Grant (ID No. APP1069043)
Participation in the MODERN trial among adults without any prior ..
clinical evidence of cardio-metabolic disease identified four people
.. from the National Health and Medical Research Council of Australia.
.. Both authors are the recipients of project research funding. M.J.C.
with CVD who underwent medical treatment and five people who ..
.. undertook analyses, data interpretation and wrote the manuscript. P.Z.Z.
were newly diagnosed with T2D and started glucose-lowering medi- .. provided critical revision of the manuscript. Both authors read and gave
cations. Pharmacologic medications were either started or adjusted .. final approval of the submitted manuscript.
..
for 24 people for BP management and 18 people for lipid manage- ..
ment. These rescue plans might not have otherwise occurred or may .. Conflict of interest: none declared.
..
have been delayed if it were not for the increased likelihood of detec- ..
tion and referral by nurses. ..
.. Data availability
Other key strengths of our study were that it was a rigorously .. The datasets generated and analysed during the current study are
designed, pragmatic trial in a real-world community setting, with a
..
.. available from the corresponding author on reasonable request.
minimal drop-out rate of around 6% that was accounted for by inten- ..
tion to treat. Self-selection to participate influences the generalizabil-
..
.. References
ity of our results and we may have introduced bias towards those .. 1. Australian Bureau of Statistics. Causes of Death, Australia 2018. Canberra, ACT:
..
with relatively moderate levels of risk, albeit the daily step count we .. Australia. https://www.abs.gov.au/AUSSTATS/abs@.nsf/Lookup/3303.0Mainþ
found was high and may be representative of a more labour intensive .. Features12018?OpenDocument (10 July 2020).
.. 2. Australian Bureau of Statistics. Changing patterns of mortality in Australia, 1698-
regional workforce whereby agriculture and manufacturing are the .. 2017. Canberra, ACT: Australia. https://www.abs.gov.au/ausstats/abs@.nsf/
main employment industries. We used objective measures for assess- .. Lookup/by%20Subject/3303.0.55.0031968-2017Main%
..
ing cardio-metabolic health, excepting self-reported health status and .. 20FeaturesChanging%20Patterns%20of%20Mortality%20in%20Australia%20%

medications, which were verified by additional information collected .. 20%201 (10 July 2020).
.. 3. Australian Institute of Health and Welfare. Cardiovascular disease, diabetes and
including electrocardiography, symptom assessment, and Medicare . chronic kidney disease-Australian facts: Risk factors. Cardiovascular disease,
Outcomes from the MODERN randomized controlled trial 35

diabetes and chronic kidney disease series no. 4. Cat. no. CDK 4. Canberra,
..
ACT: Australia.
..
..
4. Movsisyan NK, Vinciguerra M, Medina-Inojosa JR, Lopez-Jimenez F. ..
Cardiovascular diseases in central and eastern Europe: a call for more surveil- ..
lance and evidence-based health promotion. Ann Glob Health 2020;86:21. ..
5. Timmis A, Townsend N, Gale CP, Torbica A, Lettino M, Petersen SE, Mossialos ..
EA, Maggioni AP, Kazakiewicz D, May HT, De Smedt D, Flather M, Zuhlke L, ..
Beltrame JF, Huculeci R, Tavazzi L, Hindricks G, Bax J, Casadei B, Achenbach S, ..
Wright L, Vardas P; European Society of Cardiology. European Society of
..
..
Cardiology: cardiovascular disease statistics 2019. Eur Heart J 2020;41:12–85.
6. Kotseva K, De Backer G, De Bacquer D, Ryden L, Hoes A, Grobbee D, Maggioni
A, Marques-Vidal P, Jennings C, Abreu A, Aguiar C, Badariene J, Bruthans J,
Cifkova R, Davletov K, Dilic M, Dolzhenko M, Gaita D, Gotcheva N, Hasan-Ali
H, Jankowski P, Lionis C, Mancas S, Milicic D, Mirrakhimov E, Oganov R,
Pogosova N, Reiner Z, Vulic D, Wood D. Primary prevention efforts are poorly
developed in people at high cardiovascular risk: a report from the European
Society of Cardiology EURObservational Research Programme EUROASPIRE V
survey in 16 European countries. Eur J Prev Cardiol 2020;2047487320908698.
21. American Diabetes Association. Standards of medical care in diabetes-2013.
Diabetes Care 2013;36 Suppl 1:S11–S66.
22. Carrington MJ, Jennings GL, Harris M, Nelson M, Schlaich M, Stocks NP, Burrell
LM, Amerena J, de Looze FJ, Swemmer CH, Kurstjens NP, Stewart S; on behalf
of the VIPER-BP Study investigators. Impact of nurse-mediated management on
achieving blood pressure goal levels in primary care: Insights from the Valsartan
Intensified Primary carE Reduction of Blood Pressure Study. Eur J Cardiovasc Nurs
2016;15:409–416.
23. Blackford K, Jancey J, Lee AH, James AP, Waddell T, Howat P. Home-based life-
.. style intervention for rural adults improves metabolic syndrome parameters and
.. cardiovascular risk factors: a randomised controlled trial. Prev Med 2016;89:
.. 15–22.
.. 24. Laatikainen T, Dunbar JA, Chapman A, Kilkkinen A, Vartiainen E, Heistaro S,
.. Philpot B, Absetz P, Bunker S, O’Neil A, Reddy P, Best JD, Janus ED. Prevention
.. of type 2 diabetes by lifestyle intervention in an Australian primary health care
.. setting: Greater Green Triangle (GGT) Diabetes Prevention Project. BMC Public
..
.. Health 2007;7:249.
.. 25. Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA,

Downloaded from https://academic.oup.com/eurjcn/article/21/1/26/6252466 by guest on 21 April 2024

7. Alberti KGMM, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, .. Nathan DM; Diabetes Prevention Program Research Group. Reduction in the in-
Fruchart J-C, James WPT, Loria CM, Smith SC; International Association for the .. cidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med
Study of Obesity. Harmonizing the metabolic syndrome: a joint interim state- .. 2002;346:393–403.
ment of the International Diabetes Federation Task Force on Epidemiology and .. 26. Tuomilehto J, Lindström J, Eriksson JG, Valle TT, Hämäläinen H, Ilanne-Parikka P,
Prevention; National Heart, Lung, and Blood Institute; American Heart
.. Keinänen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V,
..
Association; World Heart Federation; International Atherosclerosis Society; and .. Aunola S, Cepaitis Z, Moltchanov V, Hakumäki M, Mannelin M, Martikkala V,
International Association for the Study of Obesity. Circulation 2009;120: .. Sundvall J, Uusitupa M. Prevention of type 2 diabetes mellitus by changes in life-
1640–1645. .. style among subjects with impaired glucose tolerance. N Engl J Med 2001;344:
8. Mottillo S, Filion KB, Genest J, Joseph L, Pilote L, Poirier P, Rinfret S, Schiffrin EL, .. 1343–1350.
Eisenberg MJ. The metabolic syndrome and cardiovascular risk a systematic re- .. 27. Vale MJ, Jelinek MV, Best JD, Dart AM, Grigg LE, Hare DL, Ho BP, Newman RW,
view and meta-analysis. J Am Coll Cardiol 2010;56:1113–1132. .. McNeil JJ. Coaching patients On Achieving Cardiovascular Health (COACH): a
9. Ford ES, Li C, Sattar N. Metabolic syndrome and incident diabetes: current state
.. multicenter randomized trial in patients with coronary heart disease. Arch Intern
of the evidence. Diabetes Care 2008;31:1898–1904.
.. Med 2003;163:2775–2783.
..
10. Dunkley AJ, Charles K, Gray LJ, Camosso-Stefinovic J, Davies MJ, Khunti K. .. 28. Wang Q, Chair SY, Wong EM. The effects of a lifestyle intervention program on
Effectiveness of interventions for reducing diabetes and cardiovascular disease .. physical outcomes, depression, and quality of life in adults with metabolic syn-
risk in people with metabolic syndrome: systematic review and mixed treatment .. drome: a randomized clinical trial. Int J Cardiol 2017;230:461–467.
comparison meta-analysis. Diabetes Obes Metab 2012;14:616–625. .. 29. Park S, Lee S, Kim Y, Lee Y, Kang MW, Han K, Han SS, Lee H, Lee JP, Joo KW,
11. Bo S, Ciccone G, Baldi C, Benini L, Dusio F, Forastiere G, Lucia C, Nuti C, .. Lim CS, Kim YS, Kim DK. Altered risk for cardiovascular events with changes in
Durazzo M, Cassader M, Gentile L, Pagano G. Effectiveness of a lifestyle inter- .. the metabolic syndrome status: a nationwide population-based study of approxi-
vention on metabolic syndrome. A randomized controlled trial. J Gen Intern Med
.. mately 10 million persons. Ann Intern Med 2019;171:875–884.
..
2007;22:1695–1703. .. 30. Brunstrom M, Carlberg B. Association of blood pressure lowering with mortality
12. Daly B, Tian CJL, Scragg RKR. Effect of nurse-led randomised control trials on .. and cardiovascular disease across blood pressure levels: a systematic review and
cardiovascular risk factors and HbA1c in diabetes patients: a meta-analysis. .. meta-analysis. JAMA Intern Med 2018;178:28–36.
Diabetes Res Clin Pract 2017;131:187–199. .. 31. Cook NR, Cohen J, Hebert PR, Taylor JO, Hennekens CH. Implications of small
13. Shaw RJ, McDuffie JR, Hendrix CC, Edie A, Lindsey-Davis L, Nagi A, Kosinski AS, .. reductions in diastolic blood pressure for primary prevention. Arch Intern Med
Williams JW. Effects of nurse-managed protocols in the outpatient management .. 1995;155:701–709.
of adults with chronic conditions: a systematic review and meta-analysis. Ann
.. 32. Hardy ST, Loehr LR, Butler KR, Chakladar S, Chang PP, Folsom AR, Heiss G,
..
Intern Med 2014;161:113–121. .. MacLehose RF, Matsushita K, Avery CL. Reducing the blood pressure-related
14. Carrington MJ, Zimmet P. Nurse health and lifestyle modification versus standard .. burden of cardiovascular disease: impact of achievable improvements in blood
care in 40 to 70 year old regional adults: study protocol of the Management to .. pressure prevention and control. J Am Heart Assoc 2015;4:e002276.
Optimise Diabetes and mEtabolic syndrome Risk reduction via Nurse-led inter- .. 33. Blood Pressure Lowering Treatment Trialists Collaboration. Blood pressure-
vention (MODERN) randomized controlled trial. BMC Health Serv Res 2017;17: .. lowering treatment based on cardiovascular risk: a meta-analysis of individual
813. .. patient data. Lancet 2014;384:591–598.
15. Roberts C, Torgerson D. Randomisation methods in controlled trials. BMJ 1998;
.. 34. Cholesterol Treatment Trialists’ (CTT) Collaborators, Mihaylova B, Emberson J,
..
317:1301–1310. .. Blackwell L, Keech A, Simes J, Barnes EH, Voysey M, Gray A, Collins R, Baigent
16. Collins CE, Young AF, Hodge A. Diet quality is associated with higher nutrient .. C. The effects of lowering LDL cholesterol with statin therapy in people at low
intake and self-rated health in mid-aged women. J Am Coll Nutr 2008;27:146–157. .. risk of vascular disease: meta-analysis of individual data from 27 randomised tri-
17. National Vasuclar Disease Prevention Alliance. Guidelines for the Assessment of .. als. Lancet 2012;380:581–590.
Absolute Cardiovascular Disease Risk: National Heart Foundation of Australia; .. 35. Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C,
2009. .. Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L,
18. Chen L, Magliano DJ, Balkau B, Colagiuri S, Zimmet PZ, Tonkin AM, Mitchell P,
.. Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R,
..
Phillips PJ, Shaw JE. AUSDRISK: an Australian Type 2 Diabetes Risk Assessment .. Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary
Tool based on demographic, lifestyle and simple anthropometric measures. Med .. care-led weight management for remission of type 2 diabetes (DiRECT): an
J Aust 2010;192:197–202. .. open-label, cluster-randomised trial. Lancet 2018;391:541–551.
19. Carrington MJ, Kok S, Jansen K, Stewart S. The Green, Amber, Red Delineation .. 36. Perreault L, Pan Q, Mather KJ, Watson KE, Hamman RF, Kahn SE. Effect of re-
of Risk and Need (GARDIAN) management system: a pragmatic approach to .. gression from prediabetes to normal glucose regulation on long-term reduction
optimizing heart health from primary prevention to chronic disease management. .. in diabetes risk: results from the Diabetes Prevention Program Outcomes Study.
Eur J Cardiovasc Nurs 2013;12:337–345. .. Lancet 2012;379:2243–2251.
20. Carrington MJ, Stewart S. Cardiovascular disease prevention via a nurse-
.. 37. Ebrahim S, Taylor F, Ward K, Beswick A, Burke M, Davey Smith G. Multiple risk
..
...
facilitated intervention clinic in a regional setting: the Protecting Healthy factor interventions for primary prevention of coronary heart disease. Cochrane
Hearts Program. Eur J Cardiovasc Nurs 2015;14:352–361. Database Syst Rev 2011;CD001561.