Study	Country	Setting/context	Participant characteristics	Groups	Outcomes measured	Description of main results
Ahn and Kim,48 2020	South Korea	Elderly Health Promotion Center	Elderly women (>65 years) who were members of the Elderly Health Promotion Center in South Korea. The participants did not have any comorbid chronic conditions except hypertension	Normal blood pressure group (120–129/80–84) included n=18 participants High-normal blood pressure group (130–139/85–89) included 12 participants. The groups’ categories were based on the European Guidelines for the Management of Arterial Hypertension. Both groups used an exercise program that was made up of combined workouts of elastic band resistance exercise and aerobics with dance music, 3 times/week for 6 months	Framingham coronary heart disease risk score	In the normal blood pressure group, the Framingham risk score reduced from 7.98 at baseline to 7.47 post-intervention. In the high-normal blood pressure group, the Framingham risk score reduced from 17.63 at baseline to 16.17 post-intervention.
Al Mheid et al.,39 2016	United States	University	University employees for at least 2 years and covered by university-sponsored health insurance plans Participants were recruited through human resources department 711 participants were enrolled in the study, but 14% were lost to follow-up. Mean age 48.5 (11.1) years	Intervention: Counseling provided by a trained health partner focusing on promoting clinical self-knowledge and adoption of a healthier lifestyle Sampling frame: 10,000 university employees who had worked for ≥2 years and were covered by the university-sponsored health insurance plans Sampling method: Random (every 10th employee was sent an invitation to participate) Baseline characteristics: Median age 48.5 (11.1) Sex: 35% male Race: 72% White; 23% Black; 6% other Education: 82% college degree Smokers: 5% Weight: 64% overweight or obese History of high blood pressure: 34% History of diabetes: 11% Median total CVD risk score: 5.5% No control group was included	The American Heart Association “Life’s Simple 7” ideal cardiovascular health score was used to assess total cardiovascular health; Framingham risk score (FRS CHD) was used to estimate 10-year risks for coronary death or nonfatal myocardial infarction	The ideal cardiovascular health score increased by 0.28, 0.40, and 0.33 at 6-months, 1 year, and 2 years, respectively, compared with baseline visit (mean LS7 score 7.93) There was a significant mean reduction in total CVD risk score from baseline to 24 months: −12% (<0.05)
Anand et al.,53 2016	Canada	Community: Health messages sent via email Single-blind randomized clinical trial	Single-blind randomized clinical trial intervention Intervention: n=169 (n=169 -> n=164; 3% attrition) Age: 50.6 ±12.0 Sex: 79 (46.7%) M Current or former smoker: 14 (8.3%) BMI (mean, SD): men 26.8 (3.2); women 26.7 (3.9) Baseline MI risk score: 13.3 (6.3); 152 of the 169 participants randomized to the intervention were included in the primary analysis. The median number of motivational messages sent to the DHI group was 26 (interquartile range, 24–28) and the median number of health tips was 54 (interquartile range, 53–60) compared with 0 sent to the control group during 12 months. Control: n=174 (n=174 -> n=173; 0.6% attrition) Age: 50.6 ±10.9 Sex: male 99 (56.9%) Current or former smoker: 20 (11.5%) Vegetarian: 67 (38.5%) BMI (mean, SD): men 27.3 (3.6); women 26.7 (4.3) Baseline MI risk score (mean, SD): 13.3 (6.9); 159 of the 174 participants randomized to the control were included the primary analysis	DHI: Dietary intake and physical activity were targeted each for 6 months. Participants randomized to a DHI received the following types of messages: i) stages of change: oriented motivational messages, which supported confidence in behavior change, sent by email every 2 weeks; and ii) health tips focused on diet and physical activity sent by email or text messages (participant’s choice) every week. Participants were also encouraged to access the SAHARA website for South Asian–specific prevention advice Control participants randomized to the control condition were encouraged to access the SAHARA website	Clinical assessments at 6 months and 1 year after randomization MI risk score: age, sex, brief dietary and physical activity questions, tobacco exposure, psychosocial stress, blood pressure, waist and hip circumference, and levels of apolipoprotein A and B and hemoglobin A1C Ratio of ApoB: ApoA1 A1C level Self-reported type 2 diabetes mellitus Self-reported hypertension BP Waist-to-hip ratio Current or former smoker; exposure to second-hand smoke Stress during past year Depression ≥2 wk in past year No. of servings per day of fruits and vegetables, deep-fried foods, salty snacks, meat, or poultry Moderate or very active in leisure time	The MI risk score decreased from 13.3 to 12.3 in the intervention group and from 13.3 to 12.6 in the control group. The relative change between intervention participants and controls was not significant (−0.27; 95% CI, −1.12 to 0.58; p=0.53) and remained nonsignificant in the adjusted model (−0.39; 95% CI, −1.24 to 0.45; p=0.36). No difference between the intervention and control participants was observed in the sensitivity analysis among participants with high adherence (−0.02; 95% CI, −1.05 to 1.01; p=0.97). Furthermore, no changes in the measured components of the risk score occurred between baseline and the end of the study.
Balducci et al.,61 2012	Italy	Hospital/clinic	Recruitment/sampling: Sedentary patients with type 2 diabetes Randomization: stratified by center and, within each center, by age (<60 vs. >=60 years) and type of diabetes treatment (diet with or without oral agents vs. insulin) using permuted-block randomization software.	RCT with 2 study groups: intervention and standard care Group 1 (intervention, n=303 baseline; n= 288 12 months): Structured, individualized counseling aimed at achieving the currently recommended amount of PA by encouraging any type of PA. Age (mean, SD): 58.8 (8.5) Gender: 58% M, 42% F History of hypertension: 67.4% History of diabetes: 6.6% Total CVD risk score (UKPDS) at baseline (mean, SD): 19.5% (13.3) Protocol adherence: mean attendance 80.3%; attrition rates 5.0%. Group 2 (standard care, n= 303 baseline; n= 275 12 months) Standard care consisted of a treatment regimen aimed at achieving optimal glycemic, lipid, BP, and body weight targets, as established by current guidelines. Age (mean, SD): 58.8 (8.5) Gender: 58% M, 42% F History of hypertension: 60.7% History of diabetes: 8.0% Total CVD risk score (UKPDS) at baseline (mean, SD): 18.5 (12.2) Attrition rate: 9.25%	Global CHD 10-year risk (UKPDS) A1C Blood glucose BMI BP Triglyceride Total cholesterol HDL	PA/exercise-induced improvements in in UKPDS (−0.152, p=0.027). Control group 10-year CHD UKPDS risk score baseline to 12 months: 18.5 (12.2) vs 17.8 (12.0); p=0.08 Exercise group 10-year CHD UKPDS risk score baseline to 12 months: 19.5 (13.3) vs. 15.8 (10.4); p <0.001 Exercise vs. control p value <0.001. There was also improvement in physical fitness: higher VO2 max associated with decrease in A1C from baseline to end of study (−0.023, p=0.03); decrease in waist circumference (−0.206, p<0.0001); increase in HDL (0.206, p=0.038)
Baldwin,52 2015	USA	Community	n=38 Age (mean, SD): 58 years (32) 45% were widowed, divorced, or single; 20% were uninsured	The pilot study used a non-randomized, pretest–post-test, 1-group design without comparators. The program was adapted from several programs with established efficacy that used the Small Steps, Big Rewards Program (National Diabetes Education Program, 2010). The program encompassed multilevel interventions, such as a combination of PA classes and walking, assignments, wellness education classes, cooking, motivational interviewing groups, and health coaching. Individual health coaching and motivational interviewing group sessions helped participants to select and attain goals and plans of action. Lifestyle modification, education classes, and individualized health coaching were scripted and delivered by students. Program adherence was defined as completion of the orientation session, at least 11 of the 14 active-phase classes, and post-program measurements.	Total risk score: American Heart Association guidelines (2012) and 4 clinical outcomes (A1C, BMI, waist-to-hip ratio, and BP) Systolic BP Diastolic BP BMI A1C Questionnaires assessed: Health behavior total (unclear how it was determined) Physical activity (unclear how it was determined) Nutritional behavior (unclear how it was determined)	Baseline vs. 12-week, paired t-test, significance Total risk score: 30.1 (4.5) vs. 26.8 (3.2), 3.14, p ≤ 0.05 Systolic BP: 146.8 (11.2) vs. 135.7 (8.3), 2.57, not significant Diastolic BP: 84.6 (6.2) vs. 83.9 (5.1), 1.44, not significant BMI: 38.7 (3.0) vs. 35.48 (2.0), 3.44, p ≤ 0.05 A1C: 6.8 (3.0) vs. 6.0 (1.5), 3.04, p ≤ 0.05 Health behavior total: 66.3 (8.1) vs. 69.7 (5.0), −2.02, p ≤ 0.05 Physical activity: 1.88 (0.2) vs. 2.58 (0.3), −6.75, p ≤ 0.05 Nutritional behavior: 3.41 (0.3) vs. 3.47 (0.2), −0.93; not significant
Bebenek et al.,57 2010	Germany	University	Recruitment/sampling: 128 women Women 48 to 55 years old, 1 to 3 years after menopuase Simple random sampling: mailings Computer-generated block randomization stratified for menopause age	RCT including 3 study groups: exercise program, exercise plus CR program, wellness control. Group 1 (exercise program, n=43 baseline; n= 36 12-month) Age (mean, SD): 52.3 (2.3) Gender: 100% F Smokers, current: 11.6% Weight (mean, SD): 69.5 (9.6) kg History of diabetes: 0% Total CVD risk score at baseline (mean, SD): 6% (2.5) Protocol adherence: attendance rate 76.3% group session; 42.2% home training Attrition rates: 16.3%. Group 2 (exercise + CR, n= 43 baseline; n= 37 12-month) Exercise program in addition to 40mg/day Cimicifuga racemosa (CR) Age (mean, SD): 51.8 (2.7) Gender: 100% F Smokers: 9.3% current Weight (mean, SD): 72.0 (16.8) kg History of diabetes: 0% Total CVD risk score at baseline (mean, SD): 6.2% (2.5) Attrition rate: 14%. Group 3 (Wellness Program, n= 42 baseline; n= 30 12-month) Mean (SD): 52.4 (2.7) Gender: 100% F Smokers: 14.3% current Weight (mean, SD): 70.9 (16.8) kg History of diabetes: 2.4% Total CVD risk score at baseline (mean, SD): 6.7% (3.5) Attrition rates: 28.6%.	10-year CHD risk (FRS CHD) Not considered primary or secondary endpoint, but used to calculate FRS: fasting glucose total cholesterol HDL triglyceride blood pressure	Control group CHD risk score baseline, 12 month, Diff (95% CI): 6.7 (3.5); 7.8 (3.8); 1.10 (2.09) p=0.007 Exercise group CHD risk score baseline, 12 month, Diff (95% CI): 6.0 (2.5); 6.1 (2.1); 0.16 (1.89) p=0.603 Exercise + CR group CHD risk score baseline, 12 month, Diff (95%CI): 6.2 (2.5); 7.0 (3.1); 0.78 (1.98) p=0.018 No significant changes were observed among the groups.
Bernocchi et al.,49 2011	Italy	Hospital/clinical	Recruitment/Sampling: 27 men and women age <75 years with 3+ risk factors (smoking, HTN, DM, obesity, hyperchol) Sampling not mentioned	Quasi-experimental pre- and post-test with Group 1 (n= 27 baseline; n= 27 6-month): At least 3 sessions a week of bicycle exercise training or fast walking for at least 30 minutes. Age (mean, SD): 54.9 (9.0) Gender: 37% F Smokers: 14.8% Weight (mean, SD): 92 (18) kg Waist circumference (SD): 110 (4) cm History of hypertension: 100% History of diabetes: 30% Total CVD risk score at baseline (mean, SD): FRS 10 (6) Total CVD risk score at baseline (mean, SD): Progetto 10 (8) Protocol adherence: attendance rate 64 sessions (3.7%), 19% with 3+ sessions per week Attrition rates: 0%	10-year CVD risk (FRS CHD) 10-year Progetto CUORE, BMI, weight, blood glucose, total cholesterol, HDL, Triglyceride, BP, activity Level	Baseline vs. 6-month, 10-year CVD risk (FRS CHD): 10 (6) vs 8 (6) p=0.05 10-year BMI: 2 (6) vs 31 (5) p=0.01 Total cholesterol: 230 (43) vs 222 (46) NS HDL: 50 (9.6) vs 47 (8.3) NS Triglyceride: 193 (17) vs 151 (76) NS BP: 132 (12)/78 (7) vs 130 (11)/77 (6) NS Sedentary (%): 76.2 (8.7) vs 71.5 (9.3) p=0.01
Brotons et al.,67 2021	Spain	Primary health care centers in urban and semi-urban areas	464 subjects were randomly assigned to intervention or control groups Gender: 59.3% M Age (mean, SD): 61.0 (8.0) years	Intervention group (n=228) provided tailored education about the meaning of absolute CVD risk, relative risk, and vascular age. The control group (n= 236) were visited at the beginning of the study and 1 year after the baseline visit. There were no significant differences between the 2 groups at baseline.	Primary outcome was total CVD risk, estimated using the REGICOR score, which was modified from Framingham-Wilson score for the Girona region in Spain. Framingham-Wilson risk score estimates 10-year risk of coronary morbidity and mortality	The REGICOR score reduced from 7.65% to 7.02% (p = 0.005) in the intervention group. The control group did not have any significant reduction in total CVD risk score (7.70% to 7.25%, p=0.059). There were no statistically significant differences between intervention and control groups.
Chan et al.,47 2012	Hong Kong	Local community and a rehabilitation hospital in Hong Kong	Cantonese-speaking Chinese adults aged ≥18 years old with no history of CVD were enrolled in a single group pre- and post-intervention study 215 participants were recruited from the community on the voluntary basis Age (mean, SD): 51.1 (9.5) years Attrition rate: 30%	Sampling frame: 250 community-dwelling individuals were invited to participate in the study. To be eligible, the participants had to be free of CVD, uncontrolled CVD risk factors, and cognitive impairment 35 of those invited were ineligible, and 215 were enrolled in the study Sampling strategy: convenient sample of those who met eligibility criteria The intervention included 14 sessions of empowerment workshops on cardiovascular health, diet, and community exercise classes. During the empowerment sessions, a physiotherapist and a nurse facilitated subjects to adopt healthy behaviors and lifestyle through active and mutual participation, goals setting, action planning, self-reflection, and peer-support. Assessment of different health domains, self-efficacy, and risks were also conducted. Baseline characteristics: Age (mean, SD): 51.1 (9.5) years Gender: 59% F SmokersL 7% Weight: 40% obese Race: 100% Chinese History of diabetes: 5.6% History of HTN: 33%. The baseline total CVD risk score was 8.73% (8.29)	Total CVD risk estimated using FRS to estimate 10-year risk of general CVD (CHD, stroke, PVD, CHF, cardiac death) Lab-based measures, including fasting blood glucose, total cholesterol, HDL cholesterol, and triglycerides were assessed after overnight fast (method not discussed). LDL cholesterol formula not specified. BP measurements taken according to the recommendation of the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC7). The protocols for anthropometric measurements are not described.	Baseline to post-intervention (14 sessions) changes (mean unless otherwise noted) Significant changes were reported for: total CVD risk (FRS) −3.4% (15.3 vs 11.93, p<0.001) for men; 0.6% (6.18 vs 5.56, p=0.01) for women. The overall change in total CVD risk score was −1.4% (8.66 vs 7.29, p<0.001); SBP: 1% (127.80 vs 126.53, p>0.05); DBP: 2.1% (76.25 vs 74.63, p=0.01); total cholesterol −0.7% (5.30 mmol/L (204.95mg/dL) vs 5.26 mmol/L (203.4mg/dL), p>0.05); HDL 3.9% (1.36 mmol/L [52.59 mg/dL] vs 1.42 mmol/L [54.91 mg/dL], p<0.001); LDL −1% (3.34 mmol/L [129.16mg/dL] vs 3.31 mmol/L [128mg/dL], p>0.05); and fasting blood glucose −0.3 (5.18 mmol/L [93.33 mg/dL] vs 5.16 mmol/L [92.97 mg/dL] p>0.05). No other outcomes of interest are reported.
Curtis et al.,59 2012	UK	Hospital/clinic	Recruitment/sampling: 118 postmenopausal women aged 51–74, with T2DM Simple random sampling: general practitioners, specialists, advertisements Randomization: simple randomization balanced by age, BMI, years since menopause, and insulin use	RCT with 2 study groups Group 1 (Flavonoid-enriched, n=59 baseline; n= 47 12-month) Daily intake of 27g flavonoid-enriched chocolate/1 year, 90mg epicatechin, 100mg isoflavones Age (mean, SD): 62.1 (0.73) years Gender: 100% F Smokers: 30% past Weight (mean, SD): BMI 32.69 (1.09) History of HTN: 60% (medicated for HTN) History of diabetes: 19% (medicated with insulin) Total CVD risk score at baseline (mean, SD): 9.35% (0.56) UKPDS CHD RISK Total CVD risk score at baseline (mean, SD): 6.14% (0.49) Attrition rates: 20.3% Group 2 (Placebo, n= 59 baseline; n= 46 12-month) Placebo chocolate twice a day for a year Age (mean, SD): 62.98 (0.8) years Gender: 100% F Race/ethnicity: not provided Smokers: 41% BMI (mean, SD): 31.85 (0.87) History of HTN: 54% History of diabetes: 20% (medicated with insulin) Total CVD risk score at baseline (mean, SD): 10.21% (0.65) UKPDS CHD RISK Total CVD risk score at baseline (mean, SD): 6.79% (0.56) Attrition rates: 22%	10-year UKPDS CHD RISK; 10-year UKPDS FATAL CHD RISK; 10-year UKPDS STROKE RISK HOMA-IR; glucose; insulin; triglycerides; LDL; total cholesterol; HDL; SBP A1C	Flavonoid-enriched group vs placebo group at 12 months: 10-year UKPDS CHD RISK 9.44 (0.57) vs 11.33 (0.73) (p<0.05).
Elramli,55 2017	United Kingdom	Hospitals (ie, rheumatology outpatient clinics at Gartnavel General Hospital, Glasgow Royal Infirmary Hospital and Stobhill Hospital in Glasgow, UK)	Patients ≥18 years old with rheumatoid arthritis who were within 5 years of diagnosis and free from severe HTN, joint replacement in the previous 6 months, unstable cardiac conditions or other serious pathology affecting their ability to take part in physical activity 76 participants were recruited Mean age: 56 years Attrition rate: intervention group 4.1%; control group 40.6%	Sampling frame: 320 patients with rheumatoid arthritis were invited to participate in the study; 244 (76%) did not meet the eligibility criteria 76 participants were enrolled in the study, which lasted for 6 months There were no significant difference in baseline characteristics for the intervention and control groups in regards to: mean age 58.2 vs 54.5 years; 74.4 vs 91,1% female, 25.6 vs 24.3% smokers, 28.1 vs 26.7 mean BMI, 25.6 vs 24.3% tobacco use; 124 vs 125 mean BP. No data on race or diabetes are provided. Mean total CVD risk score at baseline: intervention group 19.4% (16.3); control group 19.6% (15.0). Intervention: 6 interactive weekly sessions lasting about 1 hour. In addition, a physiotherapist contacted the participants at the end of weeks 7, 9, and 11 to discuss their step counts for the past month, their step goals for the following month, any barriers to PA they faced, and how they planned to overcome them. Participants also received 2 booster sessions: 3 and 6 months after starting the program. The control group received 1 education session regarding the importance of exercise and healthy diet, were given written education material and encouraged to read it.	The outcomes included total CVD risk, estimated using ASSIGN score that estimates 10-year risks of CVD Lab-based measures, including blood glucose levels, total cholesterol, and HDL cholesterol, were evaluated following the standard operating procedures. Blood glucose was measured immediately using YSI 2300 STAT plus Glucose and Lactate Analyzer. BP was measured with the participants in a sitting position from the right arm and a mean of the 3 readings recorded. Height was measured to the nearest 0.5cm via stadiometer. PA was assessed using step count via activPALTM.	There were significant differences in total CVD risk score, systolic blood pressure, and step count between the intervention vs control groups at 6 months. Difference in total CVD risk was −7.8 mmHg (16.1 vs 24, p<0.001) Difference in systolic BP was −13.9 mmHg (116.9 vs 130.7, p<0.001) Difference in step count was 3599 (9820 vs 6221, p<0.001) No significant between group differences were evident in glucose, weight, BMI, total cholesterol, HDL and LDL
Fontana et al.,60 2007	US	Community	48 men and women, age 50–60 years with BMI in the 23.5–29.9 range, who were weight stable for >3 months, non-smokers. If female, post-menopausal were recruited to participate.	Exercise group: the intervention was a 12-month exercise program with a goal of inducing an energy deficit comparable to the diet intervention through exercise and no change in caloric intake. The exercise group prescription started with an approximately 16% increase in energy expenditure over baseline expenditure for 3 months, followed by a 20% increase for the final 9 months. Exercise trainers worked with participants individually to establish and monitor their exercise routines, provide advice and encouragement, and update exercise prescriptions weekly. The method used to recruit participants was not reported. 379 volunteers were assessed for eligibility with 321 excluded and 63 declining to participate. Of the 58 who were eligible and willing to participate, 10 withdrew before the baseline assessment, leaving a final sample of 48. Participants were randomized 2:2:1 to the diet caloric restriction (CR), exercise (EX), or healthy lifestyle (HL) groups. There were 18 participants randomized to the exercise group. Age (mean, SD): 58.9 (2.70) years Gender: 67% (n=12) F; 33% (n=6) M Race/ethnicity: 89% White, 6% Black, 6% other Smokers: none (smokers were excluded) Weight (mean, SD): BMI not reported separately for each group History of hypertension: not reported Total CVD risk score at baseline (mean, SD): Framingham 10-year CHD risk score M=7.6 (2.7) Attrition rates: 2 participants (11.1%). Group 2 was the diet intervention group. The goal of this intervention was to decrease energy intake without changing energy expenditure. The diet intervention prescription started with a 16% decrease below the participants’ baseline energy intake for 3 months and then increased to 20% for the remaining 9 months. For 5 days during the first month participants received all meals from the research study. They attended weekly group meetings with a dietician and a behavioral psychologist and were encouraged to record their food and beverage consumption daily. Number of participants included in the group: 18 Age (mean, SD): 55.2 (3.4) years (significantly younger than the exercise group, which was controlled for during analysis) Gender: 61% (n=11) F; 39% (n=7) M Race/ethnicity: 94% White, 6% other Smokers: none (smokers were excluded) Weight (mean, SD): BMI not reported separately by group History of hypertension: not reported Total CVD risk score at baseline (mean, SD): Framingham 10-year CHD risk score M=6.8 (4.6) Protocol adherence: Based on 7-day food diaries, energy expenditure decreased ~ 300 kcal/day; energy expenditure did not change. Attrition rates (%): none The control group received general information about a healthy diet and were offered free yoga classes. Number of participants included in the group: 10 Age (mean, SD): 56.0 (2.7) years, significantly younger than the exercise group Gender: 60% (n=6) F; 40% (n=4) M Race/ethnicity: 70% White, 20% Black, 10% other Smokers: none (smokers were excluded) Weight (mean, SD): weight and BMI were not reported separately by group History of hypertension: not reported Total CVD risk score at baseline (mean, SD): Framingham 10-year CHD risk score M=7.7 (5.7) Attrition rates: 10% (n=1) Protocol adherence: neither energy intake nor expenditure changed significantly in the control group.	Outcomes assessed: Framingham 10yr CHD risk score, SBP, SBP, BMI, weight, % body fat, total cholesterol, HDL, LDL, total cholesterol/HDL ratio, triglycerides	Total CVD risk score With group: there as a significant decrease in the CR (from M=1.45 (0.73) at baseline to 1.10 (0.61) at 12 months, p=0.0007) and HL groups (from 1.82 (0.93) at baseline to 1.51 (0.77) at 12 months, p=0.008); no significant change (p=0.62) in the exercise group. There was a significant difference in the changes across the 3 groups (p=0.01), with the change in the dietary intervention group (−0.34 [0.34], p<0.001) significantly greater than the exercise group (+0.04 [0.33], p<0.05). Blood pressure: no significant within or between group differences in SBP or DBP. BMI: BMI decreased significantly in both the exercise group (M=27.1 [1.9] to 24.8 [2.6]) and the dietary intervention group (M=27.1 [2.5] to 24.2 [2.8]); p-value not reported. Weight: Weight loss averaged 6.6 (5.5) kg in the exercise group, 8.2 (4.8) kg in the dietary intevention group and 1.2 (2.1) kg in the control group; p value not reported. Total body fat also decreased significantly: 5.6 (4.9) kg in the exercise group, and 6.3 (3.8) kg in the dietary intervention group; p-value not reported. Total cholesterol: there was a significant decrease from 5.48 (0.77) to 4.91 (0.88) mmol/l in the dietary intervention group, p<0.0001; there were no significant within-group changes in the exercise or control groups. Across the groups, the differences in change scores were significant, with the change in the dietary intervention group (M=−0.57 [0.46] mmol/l) significantly different than the control group (M=−0.06 [0.52] mmol/l). HDL: No significant within- or between-group differences. LDL: significant within-group differences in the exercise (from M=2.15 [0.82] to 2.71 [0.77] mmol/l, p=0.01) and the dietary intervention (from 3.39 [0.62] to 2.87 [0.64], p<0.0001) groups. No significant change in the control group. Across groups, there were significant (p=0.004) differences in the change in LDL with reductions in both the exercise (M= −0.43 [0.59], p<0.05) and dietary intervention (M= −0.49 [0.64], p<0.05) groups significantly greater than in the control group (M=+0.18 [0.49]). Total cholesterol/HDL ratio: there were significant within-group differences in the exercise (from M=3.7 [0.70] to 3.2 [0.70], p=0.004) and dietary intervention (from M=3.9 [1.0] to 3.3 [0.80], p<0.0001) groups, but no significant change within the control group. There were significant differences across the 3 groups in the change in the total cholesterol/HDL ratio (p=0.002), with significantly larger changes in the exercise (M= −0.5 [0.6], p<0.05) and dietary intervention groups (M= −0.6 [0.5], p<0.05) compared to the control group (M=+0.1 [0.03]).
Hanlon et al.,54 1995	United Kingdom	Participants were recruited from 2 work sites in Glasgow. The intervention site was a large engineering factory with over 2600 employees, while the control group site was an engineering and repair facility with 290 employees.	Blue collar workers who were not on permanent night shifts were recruited in a randomized clinical trial. Recruited participants were not participating in other cardiovascular studies and were not taking lipid-lowering agents. The age range was 20 to 65 years. The attrition rate data is not provided.	Intervention site sampling frame: 1600 subjects who were not on permanent night shifts and not taking lipid-lowering agents were randomly selected and invited to participate in the study. A total of 1381 subjects accepted the invitation and 1371 were enrolled in the study (10 were ineligible); 261 employees in the control group site were enrolled in the study. The intervention entailed a health education package that included an interview backed up by written information. Eligible participants at the intervention site were randomized to 5 groups. Participants recruited at the control site are considered group 6 of the study. There were no significant differences between study groups in key baseline measurements. The only baseline characteristics provided for the entire study included age range (20–65 years) and gender (11% female). The study lasted for 12 months. Group 1 received health education without feedback on cholesterol concentration or risk score. Group 2 received health education with feedback on cholesterol concentration but without feedback on risk score. Group 3 received health education with feedback on risk score but not on cholesterol cconcentration. Group 4 received a full health check: health education with feedback on cholesterol concentration and on risk score. Group 5 acted as an internal control group, their intervention being delayed, but was administered after 5 months instead of the end of the study to promote participation. Group 6 subjects from the control site were recruited as the external control group for the study. Their intervention was delayed but was administered after 5 months instead of the end of the study to promote participation.	The outcomes included total CVD risk, estimated using Dundee risk score that estimates 5-year risks of coronary heart disease. Non-fasting plasma cholesterol measures were taken. No data is provided on assays used or LDL computation. Blood pressure was assessed using a random zero sphygmomanometer, measured twice after resting for 5 minutes). No data on anthropometric assessments (height, body mass, waist).	Internal control vs full intervention: There were no significant differences between the full health check intervention (group 4) and the internal control (group 5) in Dundee risk score. The between group difference in mean Dundee risk score at the end of the 5th month of the intervention was 0.19 (95% CI: −0.11 to 0.50, p=0.21). Between group 4 and 5, small but significant changes were reported in mean cholesterol concentration (0.16 vs 0.03 mmol/l) with a difference in change of 0.13 mmol/ (95% CI for difference in change 0.02 to 0.22), p=0.02). External control vs full intervention: There was a modest difference between the full health check intervention (group 4) and the external control (group 6) in Dundee risk score at the end of the intervention. The between group difference in mean Dundee risk score at the end of the 5th month of the intervention was 0.28 (95% CI: −0.01 to 0.58, p=0.05). Other comparisons of interest were not significant.
Kemmler et al.,56 2010	Germany	Hospital/clinic (identified via health insurance)	Recruitment/sampling: 246 F, all members of Siemens Health Age: >65 years Computer-generated block randomization stratified for age Randomization: stratified randomization (by age)	This was an RCT including 2 study groups: exercise program and wellness program Group 1 (exercise program, n= 123 baseline; n= 115 18-month): The weekly exercise program consisted of 2 60-minute supervised group classes and 2 20-minute home training sessions. Group classes were structured into 4 sequences. Age (mean, SD): 68.9 (3.9) years Gender: 100% F Smokers: 3.3% Weight (mean, SD): 68.1 (10.9) kg History of hypertension: 41.5% History of diabetes: 8.1% Total CVD risk score at baseline (mean, SD): 10.5 (4.2) Protocol adherence: attendance rate 76.3% group session, 42.2% home training Attrition rates: 6.5% Group 2 (wellness program, n= 123 baseline; n= 112 18-month): Program focused on well-being and was designed not to cause physical adaptations. These participants executed a low intensity, low frequency protocol for 60 minutes once a week for 10 weeks followed by 10 weeks of rest. The main topic changed from week to week. Within each of the 4 10-week blocks, the following activities were relaxation, games/interaction, general coordination, endurance, balance, dance, body sensitivity, muscle strength, breathing, and flexibility. Age (mean, SD): 69.2 (4.1) years Gender: 100% F Smokers: 3.3% Weight (mean, SD): 69.5 (12) kg History of hypertension: 48.8% History of diabetes: 8.9% Total CVD risk score at baseline (mean, SD): 11.2 (5) Protocol adherence: attendance rate 72.0% group session Attrition rates: 8%	10-year CHD risk (Framingham risk score) Blood pressure HDL LDL DM Smoking	Exercise vs control group CHD Risk Score Baseline: 10.5 (4.2) vs 11.2 (5.0) 18 month: 8.5 (3.4) vs 10.1 (4.7) CHD risk score: Absolute difference between groups: 0.8 (−0.08, 1.7); p 0.22 Control group CHD risk score: Difference between baseline and 18-month risk score: −1.96% (3.8) HDL: Difference between baseline and 18-month risk score: 1.8% (CI 3.1, 6.0) LDL: Difference between baseline and 18-month risk score: 3.1% (CI −0.1, 6.3) SBP: Difference between baseline and 18-month risk score: −4.8% (CI −7.1, −2.5) DBP: Difference between baseline and 18-month risk score: −7.6% (CI −9.9, −5.3) Exercise group CHD risk score: Difference between baseline and 18-month risk score: −1.15% (2.8) HDL: Difference between baseline and 18-month risk score: 6.5% (CI 4.3, 8.7) LDL: Difference between baseline and 18-month risk score: −1.9% (CI −4.5, 0.7) SBP: Difference between baseline and 18-month risk score: −3.5% (CI −5.8, −1.3) DBP: Difference between baseline and 18-month risk score: −8.7% (CI −10.9, −6.6)
Kemmler et al.,44 2016	Germany	Community settings: females living in the area of in Erlangen-Nuremberg, Germany	Nonrandomized, semi-blinded (outcome assessors) exercise trial with parallel group design. Two group classes of 60 to 65 minutes and 2 home exercise training sessions of 20 to 25 minutes for 49 to 50 weeks a year Participants could join their preferred study group.	Initial group (n=86); completers (n=59); 31.5% attrition Age: 55±3.3; 55.3±3.4 years BMI: 25.2±3.2; 25.7±3.4 kg/m2 Total body fat %: 36.0±5.0; 35.6±4 Physical activity: 4.1±1.3; 4.3±1.2; assessed by self-rated physical activity score (1 [very low] to 7 [very high]) Exercise volume, min/wk: 82±75; 85±79 Weekly attendance: supervised sessions stable (1.5–1.6 sessions/wk), whereas home training frequency decreased linearly from year 2 (0.96) to year 16 (0.61 sessions/wk).	BMI waist circumference 10-year risk index of myocardial infarction or coronary death (Framingham) Total CVD risk Blood pressure Total cholesterol HDL LDL triglycerides Fasting blood sugar Diet (5-day protocol where food weighed precisely and documented using protocols provided)	Only 10-year CVD risk reported: Exercise baseline vs. 16-y follow-up: 1.57±0.91 vs. 6.50±3.17; difference = 4.92±2.94; p <0.0001 Control baseline vs. 16-y follow-up: 1.36±0.80 vs. 8.06±4.36; difference = 6.69±3.98; p <.0001 Absolute difference (control–exercise): 1.77, p = 0.024; effect size = 0.51
Khanji et al.,66 2019	United Kingdom	A single-center, 2-arm randomized controlled trial with 1:1 allocation to e-coaching and standard of care (SOC) versus SOC alone. Participants with a 10-year QRISK2 CVD risk of ≥10% were enrolled.	Potential participants were identified from primary care database searches, were aged between 40 and 74 years, and had a 10-year CVD risk score of at least 10% based on the UK validated QRISK2 score.	Intervention group (n=205, age 65.1 [6.3] years, 62% female, 88.8% White) The intervention included electronic coaching, using personalized web-based lifestyle and risk factor counseling on top of SOC. The SOC group (n=197, age 65.9 [4.8] years, 64% female, 87.3% White) SOC of care, which entailed personalized, face-to-face counseling on cardiovascular risk factors during the baseline visit. There were no significant differences between the 2 groups at baseline.	The 10-year Framingham CVD risk score at 6 months.	Baseline to post-intervention (6 months) changes: Significant within-group changes in total CVD risk were reported for the treatment (−1.23) and control (−1.37) group. There were no between group differences in the Framingham risk scores.
Kim et al.,42 2011	South Korea	Hospital/clinic	Recruitment/sampling: 54 adults with Type 2 DM and metabolic syndrome (analysis included 43 participants who completed the study) Convenience sampling	Pre-test and post-test, quasi-experimental design with 2 study groups: intervention and control. Group 1 (intervention, n= 27 baseline; n= 21 16-week): Individual 60 to 90-minute initial counselling session and 30 to 40-minute follow-up every 2 months. 150 minutes of moderate exercise (3–5 days per week) Age (mean, SD): 56.6 (11.8) years Gender: 47.6% F Weight (mean, SD): 71.4 (14.2) kg BMI: 26.53 (3.49) History of diabetes: 100% Total CVD risk score at baseline (mean, SD): 11.93% (6.39) Attrition rates: 22.2% Group 2 (Control, n= 27 baseline; n= 22 16-week): Booklet and basic education on diabetes as part of routine care Age (mean, SD): 54.7 (9.2) years Weight (mean, SD): 73.8 (16.9) kg BMI: 31.85 (0.87) History of diabetes: 100% Total CVD risk score at baseline (mean, SD): 14.67% (8.16) Attrition rates: 18.5%	10-year UKPDS CHD Waist circumference SBP DBP	Between group differences 10-year UKPDS risk score −4.79% F=3.226 (p=0.080) Waist circumfrence −2.55 cm, F=0.587 (p=0.448) SBP −2.93mmHg F=1.008 (p=0.321) DBP −5.35 mmHg F=2.586 (p=0.116)
Lakerveld et al.,64 2013	Netherlands	Hospital/ cinic (diabetes research center)	Recruitment/sampling: Men and women aged 30–50 years, no diabetes Simple random sampling: mailings Randomization: computer-generated simple randomization, family members randomized to same group	RCT with 2 study groups: intervention and control Group 1 (intervention, n= 314 baseline; n= 249 12-month): Lifestyle intervention provided by practice nurses, 6 face-to-face 30-minute counseling sessions followed by 3 monthly tele sessions. Age (mean, SD): 43.6 (5.1) years Gender: 56.7% F Smokers: 23.9% Weight (mean, SD): 90.2 (15.5) kg Total CVD risk score (ARIC) at baseline (mean, SD): 19.0% (7.8) Total CVD risk score (SCORE) at baseline (MEAN, SD): 4.0% (3.0) Protocol adherence: Median of 2 face-to-face and 2.3 telephone calls. Attrition: 20.7% Group 2 (control, n= 308 baseline; n= 253 6-month): Brochures containing health guidelines regarding physical activity and a healthy diet. Age (mean, SD): 43.4 (5.5) years Gender: 60.1% F Smokers: 17.6% Weight (mean, SD): 90.7 (15.4) kg Total CVD risk score (ARIC) at baseline (mean, SD): 18.8% (8.5) Total CVD risk score (SCORE) at baseline (mean, SD): 3.8% (2.9) Attrition rates: 17.9%	10-year ARIC CHD risk score 10-year fatal CVD risk (SCORE) BP Weight Physical activity (light; moderate; vigorous; meeting recommendations) Dietary behavior (fruit; vegetables) Smoking Total cholesterol HDL Diabetes BP meds	Control group: ARIC: baseline 18.8%; 6 months 18.0%; 12 months 17.8%. SCORE: baseline 3.8%; 6 months 3.7%; 12 months 3.7 (4.6) Intervention group: ARIC: baseline 19.0%; 6 months 18.8%, 12 months 18.5% SCORE: baseline 4.0%; 6 months 4.0%; 12 months 4.0% No significant difference between groups at 6 or 12 months
Lazarevic et al.,43 2008	Serbia	Community	30 sedentary obese men with T2DM	Single group pre-post design, although the authors aim was to also determine if the effects of the intervention differed by SCORE risk. The intervention was a supervised 6-month aerobic exercise program consisting of 3–5 sessions of moderate aerobic exercise weekly, with an average duration of 45–60 minutes and a workout intensity corresponding to 50–75% of maximal heart rate. Study sample: obese men with T2DM were recruited from participating outpatient clinics. Age (mean, SD): 52.3 (7.4) years Gender: 100% M Race: not reported Smokers: not reported Weight (mean, SD): not reported; mean BMI 32.41 (2.44) History of HTN: not reported Total CVD risk score at baseline (SD) measured by SCORE risk median: 4% (range 1.00–17.00) Protocol adherence: not reported. Attrition rates: not reported.	Outcomes assessed: SCORE, SBP, DBP, BMI, total cholesterol, HDL, LDL, A1C, waist circumference, physical activity index. There was no dietary measures (or intervention as described).	Total CVD risk score: There was a significant decrease in SCORE risk from median=4% at baseline to median=3% (range 1–10%) at both 3 and 6 months (p<0.001 from baseline to 3 months and 3 to 6 months). Blood pressure: There was a significant reduction in SBP from m=139.93 (11.19) mm Hg at baseline to 128.13 (10.59) at 3 months and 122.66 (9.29) at 6 months (p<0.001 for both time points relative to baseline and at 3 months compared with 6 months).
Lukaczer et al.,58 2006	USA	Research center	12-week randomized, controlled trial This 12-week trial compared the effects of a dietary program combining a low glycemic index diet with a functional food delivering 30 g of soy protein and 4 g of phytosterols per day (LGID) with a standard dietary program (American Heart Association Step 1 diet; AHAD) in postmenopausal women. A community sample of menopausal women between 40 and 65 years with a blood LDL level of 3.36 to 5.17 mmol/L (130 to 200 mg/dL) and a BMI of 27 to 39 kg/m2 were recruited through newspaper, email, and radio advertisements. Randomization was also performed at visit 1 by using a standard randomization chart (Excel) Baseline characteristics: LGID (n = 30) AHAD (n = 29) Age: 55.6 ± 5.5; 54.8 ± 5.9 years Weight: 84.4 ± 2.7; 88.0 ± 2.3 kg BMI: 32.5 ± 0.6; 32.4 ± 0.7 kg/m2 Blood pressure (mm Hg) Systolic: 126 ± 1.6; 127 ± 1.8 Diastolic: 84 ± 0.8; 83 ± 0.9 LDL (mmol/L): 4.24 ± 0.13; 4.27 ± 0.10 Attrition: LGID group 27 -> 30 completed (90%) and 22/30 compliant (73%) AHAD group 26 - > 29 completed (89.7) and 20/29 compliant (69%) Compliance based on 3-day diet diary and labs at 2, 4, 8, and 12 weeks	AHAD: low-fat, high-carbohydrate diets, specifically the AHA Step 1 diet (AHAD); n = 29 Low glycemic index diet with 30 g of soy protein and 4 g of phytosterols per day (LGID); n = 30	FRS Body weight Cholesterol Total LDL HDL TG Blood pressure	The FRS for coronary heart disease was determined for subjects in each group. Subjects in both groups had similar scores at initiation of the trial (LGID: median 10.0, 95% CI 8.8 to 11.2; AHAD: median 10.0, 95% CI 8.6 to 11.5). After the intervention, however, subjects on the LGID program showed a much lower risk (median 6.0, 95% CI 4.4 to 7.6) compared with the AHAD group (median 9.0, 95% CI 7.9 to 10.1). LGID baseline vs. 12-wk; AHAD baseline vs. 12-week; p-value (repeated measures analysis of variance on log-transformed data) Body weight (kg): 84.5 ± 2.2 vs. 77.7 ± 2.0; 89.4 ± 2.5 vs. 86.0 ± 2.4; 0.0031 Total cholesterol (mmol/L): 7.10 ± 0.27 vs. 5.98 ± 0.18; 6.63 ± 0.25 vs. 6.56 ± 0.27; 0.0036 LDL (mmol/L): 4.79 ± 0.20 vs. 4.08 ± 0.14; 4.43 ± 0.20 vs. 4.58 ± 0.23; 0.0041 HDL (mmol/L): 1.25 ± 0.03 vs. 1.32 ± 0.04; 1.22 ± 0.07 vs. 1.23 ± 1.18; not significant TG (mmol/L): 2.39 ± 0.32 vs. 1.32 ± 0.13; 2.34 ± 0.41 vs. 1.79 ± 0.21; 0.006 Systolic BP: 130 ± 1.8 vs.124 ± 2.8; 128 ± 2.7 vs. 125 ± 2.1; not significant Diastolic BP: 84 ± 1.0 vs. 77 ± 1.5; 83 ± 1.5 vs. 78 ± 1.5; not significant
Márquez-Celedonio et al.,65 2009	Mexico	Community	92 prehypertensive adults (SBP 12–139 mmHg and DBP 80–89 mmHg) aged 30–55 years who agreed to make lifestyle changes. Had to attend at least 3 exercise sessions to be included.	Intervention (eg, home-based exercise program, DASH diet weight loss program): 6-month lifestyle modification program including a low-sodium, DASH diet with energy content determined using the Harris-Benedict formula. Also 3–5 sessions of aerobic exercise complemented by group sport sessions (45 minutes per session). Smokers: 6 educational classes. Participants were randomly assigned to groups, n=38 completed. Age (mean, SD) =3.97 (7.65) years Smokers: 7.8% Weight (mean, SD) BMI: 30.9 (4.9) History of HTN: by definition (eligibility criteria), all had pre-HTN Mean SBP: 133.03 (4.36); mean DBP: 87.58 (2.84) Total CVD risk score at baseline (mean, SD): FRS 5 (−10–12) (median and range) RCE (risk of CV event within 10 years): mean 5.29 (3.88) Lifestyle score (measured by the FANTASTIC questionnaire): median=62.5 (range=43–83) Protocol adherence: not reported; participant had to attend at least 3 sessions to be included. Attrition rate: not reported Control (guidelines outlining exercises they should undertake, plus dietetic recommendations. The authors reported that 43 completed the study; the number randomized to the 2 groups was not reported) Age (mean, SD): 42.56 (7.98) years Gender: not reported Race/ethnicity: not reported Smokers: n=4 (9.3%) Weight (mean, SD): BMI mean: 31.42 (5.69) History of HTN: by definition (eligibility criteria), all had pre-HTN Mean SBP=132.72 (4.18), mean DBP= 85.6 (4.05) Total CVD risk score at baseline (mean, SD): FRS 4 (−10 – 11; median and range) RCE (mean, SD): 5.79 (5.72) Attrition rate: not reported	Outcomes assessed: Total CVD score at 3 and 6 months: FRS, RCE, SBP, DBP, BMI, Total cholesterol, HDL, FBS, waist circumference, lifestyle score (FANTASTIC questionnaire) Physical and aerobic capacity was measured by the Cooper test and by determining VO2max.	Total CVD risk score: FRS: significant decrease in the Rx group (from median of 5 at baseline to 3.5 at 3 and 6 months, p<0.001) and no significant change in the control group (median of 4 at each time point, p=0.869) RCE within 10 years mean scores decreased significantly in the Rx group (from M=5.29 [3.88] at baseline to M=4.45 [3.26] at 3 months and M=4.24 [2.86] at 6 months, p<0.001) compared with no significant change in control group (mean = 5.79 [5.72] at baseline, 5.77 [4.93] at 3 months an 5.93 [5] at 6 months, p=0.962). Significantly more participants in the treatment group (63.16%) experienced a reduction in CV risk compared to 25.58% of control group participants: RR=0.3 (95% CI 0.11–0.83), p<0.05), Blood pressure: significant reduction in SBP (from mean of 133.03 [4.36] at baseline to 124.68 [9.71] at 3 months and 119 [7.97] at 6 months, p=0.01) in the intervention group; no significant change in the control group (baseline: mean=132.72 (4.18), 3 months: mean=132 (7.72), 6 months: 129.53 (9.81), p=0.126).
Price et al.,40 2000	United Kingdom	Participants were recruited from an inner-city general practice, but the intervention occurred in community settings	Patients from an inner-city general practice with at least 1 coronary risk factor and baseline cholesterol above 5.2 mmol/l (201.1 mg/dL) were recruited in a 1-group, pre-test post-test study. Participants had not received dietary advice before and were free of coronary disease and conditions or drugs likely to affect their lipid profile. Age range: 20 to 75 years Attrition rate: 6%	Sampling frame: 210 patients at an inner-city general practice with 1 or more CVD risk factors were screened; 59 (28%) did not meet the eligibility criteria (total cholesterol was <5.2 mmol/l or 201.1 mg/dL). 143 participants were enrolled in the study. The intervention entailed 1-to-1 session with a nurse, who suggested changes to their existing diet with the aim of reducing the fat content by substituting saturated fats with polyunsaturated fats. A supplementary and commonly used diet sheet, devised by the Family Heart Association, was also provided. The study lasted for 2 years. Baseline characteristics: Median age 51 and 49 years for women and men, respectively (data not provided for the entire sample) Gender: 42% F Smokers: 16.7% F and 27.2% M (data not provided for the entire sample) HTN: 40% (BP>160/90) Mean BMI, race, diabetes: not reported Median total CVD risk score at baseline: 7.7% (IQR 14.9%).	The outcomes included total CVD risk, estimated using FRS. Lab-based measures, including total cholesterol, and HDL cholesterol were assessed after 12 hours fast, and were measured from serum samples at the Department of Biochemistry, North Staffordshire Hospital. No data on LDL computation is provided. No data on anthropometric assessments (height, body mass, waist) or physiologic measures (BP) are provided.	There were no significant differences between the baseline and post intervention measures of total CVD risk, and total cholesterol to HDL ratio. However, there was a non-significant increase in median total CVD risk score from 7.7% (IQR 14.9%) to 8.5% (IQR 3.76%); p>0.05.
Richardson et al.,50 2008	UK	Community	Men and women between 45 and 65 years of age from 3 GP practices who responded to a self-screening survey without a prior history of CV disease but with risk factors.	Intervention: Assessment clinic with advice on relevant risk factors identified and, if relevant, referral to individual’s GP, a dietician, exercise program, and/or smoking cessation program. Sample: men and women from 3 GP practices were identified and invited to self-screen for eligibility to attend a more in-depth assessment of their risk for heart disease. Single group design: Age (mean, SD): not reported Of the total 290 participants, 93 (32%) were between 60 and 64; 84 (29%) between 55 and 59; 70 (24%) between 50 and 54; and 43 (15%) between 45 and 49 years of age Gender: 49% (n=142) M; 51% (n=148) F Race: all Caucasian Smokers: not reported Weight (mean, SD): 78.95 (16.74) kg BMI (mean, SD): 28.13 (4.84) History of HTN: not reported Mean 10-yr risk of CHD (%): 13.14 (9.18%) Protocol adherence (eg, mean sessions attended by participants): not reported for the intervention sessions Attrition rates: not reported	Outcomes assessed: % reduction in FRS (primary outcome), SBP, DBP, weight, BMI, waist circumference, total cholesterol, HDL, and glucose. No measure of physical activity or diet.	Total CVD risk score: The FRS was slightly lower at 1-year follow-up (M=0.876%, 95% CI 0.21–1.54%) The mean 10-year risk of CHD decreased from 13.14% (9.18) at baseline to 34% (8.71) at 1-year follow-up, a mean reduction of 6.7%. BP: Significant reduction in SBP at 12 months (M=138.65 [17.01]) compared with baseline (M=141.54 [18.68] mmHg), p<0.001 BMI: mean increased from M=28.13 (28.13) at baseline to 28.38 (4.72) Total cholesterol decreased from M=5.11 (1.04) to 5.35 (0.99) mmol/l, p=0.002 HDL increased from M=1.28 (0.38) to 1.38 (0.41) mmol/l, p<0.001
Riddell et al.,63 2016	Australia	Community	Cluster randomized controlled trial Intervention (n=120) Age: 61.3 ± 9.3 years Sex: 60 M (50.0%) Ethnicity: Caucasian 92 (83.6%); South East Asian 9 (8.2%); Indian sub-continent 7 (6.4%); Other 2 (1.8%) Smokers: 12 (10.9%) current; 43 (39.1%) previous; 55 (50.0%) never At baseline, the mean UKPDS risk score was 11.5 % (SD 7.5 %) for M and 4.2 % (SD 2.8 %) for F Participants lost to follow-up from baseline to 12 months: n=22 Control (n=120) Age: 60.5 ± 8.7 years Sex: 62 (51.7%) M Ethnicity: Caucasian 98 (87.5%); South East Asian 6 (5.4%); Indian sub-continent 4 (3.6%); other 4 (3.6%) Smokers: 6 (5.5%) current; 42 (38.5%) previous; 61 (56%) never Participants lost to follow-up from baseline to 12 months: n=11 Baseline UKPDS risk score was higher in the intervention arm	Peer support intervention: monthly community-based group meetings over 12 months led by trained peer supporters with active encouragement to use primary health care and other community resources and supports related to diabetes. Usual care was the comparison.	Weight; BMI; waist circumference; BP; total cholesterol; HDL; LDL; total cholesterol to HDL ratio; LDL to HSL ratio; triglycerides; A1C	Mean change between groups’ p-values: UKPDS risk scores reduced similarly in both groups over 12 months. The difference between arms was zero (95 % CI −0.011, 0.011, p=1.00) BMI: 31.9 ± 6.8 (17.6 – 54.1) vs. 31.9 ± 6.7 (21.1 – 49.7), −0.11 (−0.46, 0.24) 31.7 ± 5.9 (18.9 – 54.9) vs. 31.5 ± 6.2 (19.7–54.0), −0.10 (−0.38, 0.17) 1.0 SBP (mmHg) 137.4 ± 16.8 (95–192.7) vs. 128.1 ± 17.1 (96–189), −9.1 (−12.8, −5.4) 134.9 ± 15.5 (95–170) vs. 130.9 ± 16.3 (98–196.7), −5.1 (−9.1, −1.0)
Ródenas et al.,45 2005	Spain	Convent	Postmenopausal nuns from an enclosed convent were enrolled in a 1 group pre-and post-intervention study. Age (mean, SD): 63 (11) years 14 participants were enrolled in the study No attrition data is provided, although it appears that all those enrolled completed the study	Intervention: 28-day program where the culinary oil used for years in the convent (a blend of sunflower and olive oils) were substituted for extra virgin olive oil. Sampling frame: Nuns who were post-menopausal and shared a similar lifestyle and dietary habits. Sampling method: Not explicit but appears to be convenient. Baseline characteristics: Age (mean, SD): 63 (11) years Gender: 100% F BMI (mean, SD): 23.2 (3.4) History of diabetes: not reported Total CHD risk score (mean, SD): 3.64% (3.05) Smokers, race, level of education, history of HTN: not reported	Primary outcome was total CVD risk, estimated using FRS that estimates 10-year risk of coronary heart disease in accordance with ATP III guidelines. Lab-based measures including total cholesterol, HDL, and LDL cholesterol were assessed after overnight fast using standard enzymatic methods	Baseline to post-intervention (28 days) changes (mean unless otherwise noted): No significant changes were reported for total CVD risk (FRS) −0.14 (3.64 vs 3.50, p>0.05) and HDL −4.6% (72.7 vs 68.3, p>0.05) Significant changes were reported for: total cholesterol −7.33% (247.87 vs 229.7, p<0.05); and LDL −10.39% (146.15 vs 131.48, p<0.05) No other outcomes of interest are reported.
Sartorio et al.,46 2001	Italy	Hospital setting	Patients admitted between April 1999 and September 1999 to the 3rd Division of Metabolic Diseases of the Italian Institute for Auxology, Piancavallo, Italy, with a diagnosis of obesity were enrolled in a 1 group pre- and post-intervention test study. Age range (years): 19–81 (no mean or median age provided) No attrition data is provided, although it appears that all those enrolled completed the study	The intervention consisted of a 3-week integrated energy-restricted diet (1200 ± 1800 kcal/day), moderate aerobic exercise (5 days per week training), psychological counseling (2 or 3 sessions per week), and daily educational lectures. Sampling frame: All patients admitted between April 1999 and September 1999 to the 3rd Division of Metabolic Diseases with a diagnosis of obesity. Sampling method: Not explicit but appears to be convenient (all eligible participants were asked to participate) Baseline characteristics: Mean age, smokers, race, level of education: not provided Gender: 84% F BMI (mean, SD): 42.1 (6.1) History of HTN: 15% (defined as taking BP-lowering meds) History of diabetes: 8.6% (defined as taking diabetes meds) Mean total CHD risk score: 7.8%	Primary outcome was total CVD risk, estimated using FRS. Lab-based measures, including fasting blood glucose, total cholesterol, and HDL cholesterol, were assessed after overnight fast, using enzymatic-colorimetric methods (Hitachi Instrument, Japan). Two blood pressures were assessed after the participants had been sitting at least 5 minutes, and the mean value was used for analyses.	Baseline to post-intervention (3-weeks) changes (mean unless otherwise noted): Significant changes were reported for: Total CVD risk (FRS):1.6% (7.8 vs 6.2) SBP: 16.4 (136.8 vs 120.4, p<0.05) DBP: 7.7 (84.2 vs 76.5, p<0.05) BMI −1.7 (42.1 vs 40.4, p<0.05) Total cholesterol −38.9 (216.1 vs 177.2, p<0.05) HDL −7.4 (45.6 vs 38.3, p<0.05) Fasting blood glucose −15.2(101.9 vs 87.4 p<0.05) No other outcomes of interest are reported.
Siren et al.,51 2016	Finland	Hospital/local health care centre	Observational study Gender: 100% M Smokers: 55.3% Weight (mean, SD): BMI 29.5 (5.3) BP: 139.4 (16.7)/91.7 (11.1) Age, race/ethnicity, history of HTN: not provided Total CVD risk score at baseline: Modified North Karelia: 6.1 (1.6); SCORE low risk: 4.9 (2.1) Participation in 5-year follow-up rate: 159/389	Group 1 (n = 55, 34.6%) had visited no health care providers for CVD risk monitoring between baseline and follow-up. Group 2 (n = 59, 37.1%) had made visits to their primary health care centers. Group 3 (n = 45, 28.3%) had visited their occupational health care centers.	Total CVD risk score: Modified North Karelia and SCORE	The CVD risk score decreased the most in Group 2 (1.3% [95% CI: −1.6, −0.6]) compared to Group 3 (−0.6 [95% CI −1.3, 0.3]) and Group 1 (−0.1 [95% CI −0.5, 0.4]).
Tuthill et al.,62 2007	Ireland	Community setting. Patients receiving care in outpatient clinics in 2 Dublin hospitals were eligible if their BMI was >30 and their weight was stable. The method of recruitment was not described.	68 participants were recruited. Median age: 59 years 85.3% (n=58) were taking antihypertensives, 60.3% (n=41) were taking statins, and 91.2% (n=62) were taking aspirin. Baseline exercise habits ranged from none (n=29) to daily gym attendance (n=1). Characteristics were only reported for the total group. Subjects were randomized to the intervention or control group (method not reported).	Intervention group: The number of participants randomized to this group was not reported but based on the results, there were 28 subjects at the 6-month data collection point. The intervention group attended monthly evening group sessions where they received dietary advice from a dietician and exercise advise from a physiotherapist. They were given Polar Heart Rate monitors to record heart rate during exercise and an individualized exercise prescription. No data on their baseline characteristics or the adherence in attending sessions. There was a control group but there was no information about it. The number of subjects randomized to the control group was not reported but based on the results, only 28 completed the 6-month exercise period. There was no information of the characteristics of this group.	Cardiovascular risk scores using the United Kingdom Prospective Diabetes Study (UKPDS) risk engine. They only reported within-group changes from baseline to 6 months; there were no between group comparisons. Secondary outcomes reported: increase in exercise (did not report how this was measured), relationship between weight loss and exercise and SF-36 scores, and relationships between waist circumference reductions and UKPDS scores.	UKPDS Scores: Active group - CHD score changed from 18.1 (10.1) at baseline to 14.6 (7.8) at 6 months, p<0.01 Fatal CHD score changed from 11.8 (8.6) to 9.2 (6.6), p<0.01 Stroke score changed from 7.3 (6.3) to 6.6 (5.2), p<0.0.5 Fatal Stroke scores changed from 1.3 (1.5) to 1.0 (1.0), not significant. In the control group none of the baseline to 6-month scores were statistically significant: CHD-15.6 (11.2) to 16.1 (12.3), Fatal CHD from 10.2 (9.5) to 10.4 (9.5), Stroke from 6.4 (5.1) to 6.6 (5.4), and Fatal Stroke from 1.0 (1.0) to 1.1 (1.2).
Widmer et al.,41 2014	USA	Work health program; cohort study	Cohort study Online CareHere Connect Personal Health Assistant (PHA) designed and produced by Healarium, Inc (Dallas, TX). The PHA is an integrated and personalized interface that tracks, logs, educates, and forms actionable tasks for the user seeking to improve their current state of health in online and smartphone-based platforms. Reminders to complete tasks may be received via email or SMS text messaging. Participants were eligible for enrolment into the work health program and cohort if they met at least 1 of the 5 inclusion criteria: BMI (kg/m2) > 30; blood pressure (mm Hg) > 140/90; cholesterol level (mg/dL) > 220; blood glucose level (mg/dL) > 100; tobacco use	Single group demographics for the participants who were included and completed the PHA (n=508; 836 assigned to PHA and 508 completed program -> 60.8%) Age: 46.5 ± 11.1; M 126 (25%); F 382 (75%) years White: 389 (77%) Smokers: 3 (0.01%) Treated for HTN: 135 (27%) Treated for diabetes: 25 (5%) Treated for hyperlipidaemia: 39 (8%) Participants logged in on average 1.37 ±1.00 times per week.	Baseline and 90-day assessments Total cholesterol LDL cholesterol HDL cholesterol Triglycerides Glucose Systolic blood pressure Weight BMI FRS were only able to be calculated on 152 of the 508 patients	There was a 10% reduction in FRS 10-year risk percentage (2.9% ± 0.3% to 2.5% ± 0.3%, p =0.003) after 90 days using the online PHA. Baseline vs. 90-day, and the resultant changes absolute values of CVD risk factors: Total cholesterol, mg/dL (n = 157): 191.9 ± 38.8 vs. 188.1 ± 37.7; −13.1 ± 28.7; p<0.0001 LDL cholesterol, mg/dL (n = 156): 120.1 ± 37.8 vs. 111.3 ± 31.9; −8.8 ± 12.2; p < 0.0001 HDL cholesterol, mg/dL (n = 160): 47.8 ± 12.2 vs. 48.4 ± 13.1; 0.52 ± 6.6; I = 0.15 Systolic blood pressure, mm Hg (n = 462): 121.1 ± 11.1 vs. 119.4 ± 12.5; −1.8 ± 13.1; p < 0.004 BMI, kg/m2 (n = 429): 34.1 ± 6.5 vs. 33.5 ± 6.5; −0.54 ± 3.5; p < 0.001.

A1C, Glycated hemoglobin A1C; AHAD, American Heart Association Diet; ARIC, Atherosclerosis Risk In Communities; ATP III, Adult Treatment Panel III; BMI, body mass index; BP, blood pressure; CHD, coronary heart disease; CHF, cogestive heart failure; CR, Cimicifuga racemosa; CV, cardiovascular; CVD, cardiovascular disease; DASH, Dietary Approach to Stop Hypertension; DBP, diastolic blood pressure; DHI, digital health intervention; DM, diabetes mellitus; FBS, Fasting Blood Sugar; FRS, Framingham risk score; GP, general practitioner; HDL, high-density lipoprotein; HTN, hypertension; IQR, interquartile ratio; ITT, intention to treat; LDL, low-density lipoprotein; LGID, low glycemic index diet; MI, myocardial infarction; PA, physical activity; PVD, peripheral vascular disease; RCE, risk of cardiovascular event; RCT, randomized controlled trial; REGICOR, Registre Gironí del Cor (Girona Heart Registry); Rx, Treatment; SBP, systolic blood pressure; DBP, diastolic blood pressure; SD, standard deviation; SOC, standard of care; T2DM, type 2 diabetes mellitus; TG, triglycerides; UKPDS, UK Prospective Diabetes Study; VO2max, maximum (max) rate (V) of oxygen (O₂) used during exercise