Background
Methods
Search strategy
Inclusion and exclusion criteria
Data synthesis
Reach | Implementation & adaptation | Efficacy & maintenance | |||
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Name of study, Acronym Country References | Target group, Inclusion criteria | Screening, recruitment, study population (n, sex, mean age), drop-outs | Study design, follow-up (FU) duration, lifestyle goals/targets | Intervention delivery, intervention duration, change theories | Results Clinical significance estimate* |
Daqing Diabetes Prevention Study China Pan et al., 1997 [5] Li et al., 2008 [15] | People living in Daqing area, > 18 y old IGT | 110,660 people screened with OGTT 577 randomized sex: 54% men age: 45 ± 9 y | Cluster randomized controlled study in four groups: control, diet only, physical activity (PA) only, or diet plus PA FU 6 years (n = 533) + 20 years. Goals: Diet (increase vegetables, decrease alcohol and sugar, caloric and weight reduction if overweight), PA (1–2 units/day; unit = 30 min of slow walking etc., 20 min of fast walking etc. or 5 min of jumping rope etc.) or combined both | Individual counselling + compliance evaluation by physician/nurse every 3 months + small groups weekly for 1 month, monthly for 3 months and every 3 months thereafter. Intervention duration 6 years. | HRs (adjusted for baseline BMI and f-Glu): HR = 0.69 for diet vs CG, p < 0.03; HR = 0.54 for diet + PA, p < 0.0005; 0.58 (diet+PA), p < 0.005; HR = 0.41 for PA vs CG p < 0.0005. The average number of PA units per day was significantly higher after 6 years. No significant changes in diet. ++ |
Diabetes Prevention Study, DPS Finland Tuomilehto et al., 2001 [6] Lindström et al., 2003 [16] Lindström et al., 2006 [17] Lindström et al., 2013 [18] Wikström et al., 2009 [19] | People with high risk for T2D IGT in two OGTTs IGT (according WHO 1980) BMI > 25 kg/m2 age 40–64 | Opportunistic screening based on age and BMI; previous study patient files; newspaper ads. Stepwise screening (1st OGTT - > 2nd OGTT). Approximately 10% of those tested were eligible. 522 randomized sex: 33% men age: 55 years | RCT in 5 study centres in Finland. Intensive, individualized intervention vs. general “mini-intervention” at baseline. FU mean 3.2 years (n = 482) + 7 years + 13 years Goals: < 30% of total energy from fat; < 10% energy from saturated fat; at least 15 g of fiber/1000 kcal; at least 4 h/week physical activity; > 5% weight reduction. PA sessions (2/week in free gym) were offered. | 7 individual counselling sessions with nutritionist (at 2w, 5w, 3 m, 4 m, 6 m (first 1 h, later 30 min), every 3 months thereafter. Sessions included pre-defined topic + review of food and exercise diaries + goal setting with participants. 1 year intensive phase plus maintenance 1 to 5 years, mean duration 4 years. Optional very low caloric diet phase. Stages of change model, emphasizing self-efficacy, monitoring, feedback, behaviour planning, relapse management. | Diabetes incidence in 3.2 year (main results) reduced by 58%.Significant difference in changes of weight (− 4.5 kg in IG vs. -1 kg in CG at year 1), BMI, waist circumference, diet, physical activity, fasting and 2 h glucose in IG compared to CG. Effects of intervention sustained after 7 years and after 13 years. ++ |
Diabetes Prevention Program, DPP USA Knowler et al., 2002 [7] Rubin et al., 2002 [20] Fujimoto et al., 2000 [21] | aiming for 50% ethnic minorities IGT (WHO 1980) fasting glucose > 5.5 mmol/l age > 25 y, BMI > 24 kg/m2 | Recruitment with mail, advertisements in media and work sites. 133,683 individuals pre-screened, 26,518 screened with an OGTT. 3.048 randomized sex: 33% men age: 50 + 11 years 45% from ethnic minority groups | RCT in 27 clinical centres Intensive lifestyle vs. metformin vs. placebo FU mean 2.8 years, drop-out 7.5% Weight reduction 7% Diet: fat 25 E% Physical activity (e.g. brisk walking) 150 min/week (700 kcal/week) | Main goal to achieve and maintain a weight reduction of > 7% through a healthy low-calorie, low-fat diet and to engage in physical activity of moderate intensity. Goal-based behavioural intervention lasting for 2.8 years (mean); case-managers (1 per 20–26 participants) held 16-session core curriculum in groups during the first 24 weeks; individual session monthly | T2D risk reduction 58% in lifestyle vs placebo after 2.8 years. 50% of IG met the weight reduction goal after 24 weeks. Mean weight loss 7 kg (7%) at 1 year. ++ |
Prevention of type 2 diabetes by lifestyle intervention: a Japanese trial in IGT males Japan Kosaka et al., 2005 [22] | 30–60 year old men IGT (according WHO 1980) | Random selection of men with IGT from health-screening program for mostly government employees. 458 randomised n = 356 in CG, n = 102 in IG sex: 100% men age: mean NA | RCT intensive care vs. standard hospital care (1:4). FU 4 years. Drop-outs 5.6% in CG, 4,7% in IG BMI < 22; reduce energy intake by 10%; increase vegetable intake; fat < 50 g/day; alcohol < 50 g/day; eating out once /day or less; walking 30–40 min / day | Face-to-face counselling by nurse in hospital every 2–3 months, 4-year intervention. Regular weight self-monitoring. Concrete, standardised advices to reach the goals of the study. | Relative risk reduction 67% in 4 years. Body weight reduction 2.2 kg at 4 years vs. 0.39 kg in the control group ++ |
Indian Diabetes Prevention Programme, IDPP-1 India Ramachandran et al., 2006 [23] | Middle-class population; 35–55 years; IGT in two OGTT (WHO 1999) | Recruiting by workplace announcements and circulars. 10,839 subjects underwent initial screening using glucometer. n = 531; sex: 81% men age: 45.9 years | RCT in community-based setting in 4 groups: Control; metformin (MET); lifestyle modification (LSM); LSM + MET. FU 3 years (n = 502). Goals: > 30 min brisk walking daily: reduction in total calories, refined carbohydrates and fat; avoidance of sugar and inclusion of fibre-rich foods | Participants had a personal session at 6-monthly intervals and were contacted by phone every month. Diet modification was advised for each subject. | Absolute risk reduction at year 3 was 15.7% in LSM, 14,5% in MET and 15.5% in LSM + MET compared to control (all p-values for HR < 0.03). ++ |
N/A UK, Newcastle Oldroyd et al., 2006 [24] Oldroyd et al., 2001 [25] | European origin men and women aged 24–75 years IGT in 2 OGTT (WHO 1985) | Recruited people from previous research studies, local hospital and GP databases. n = 78 sex: 57% men age: 58.2 years | RCT in hospital setting; control vs intervention FU 2 years (n = 54) BMI < 25 kg/m2, dietary fat < 30 E%, polyunsaturated to saturated fat (P:S) ratio ≥ 1.0; carbohydrate 50 E%, dietary fibre > 20 g per 4.2 MJ, 20–30 min aerobic exercise at least once a week | Individual counselling from a dietician and physiotherapist using the stages of change model. Intervention lasted 2 years and 12 sessions with duration of 15–20 min. | Meeting intervention goals was higher in IG for all other but P:S ratio. In IG weight change was − 1.8 kg vs + 1. 5 kg in CG at 24 months. Significant change in fasting serum insulin between groups at 12 months. + |
Hoorn Prevention Study The Netherlands Lakerveld et al., 2012 [26] Lakerveld et al., 2013 [27] | Age 30–50 At least 10% risk for T2D and/or CVD estimated according formula of ARIC and SCORE projects. | A screening invitation to GP customers (n = 8193). 2401 respond, 921 eligible based on waist circumference. 772 were screened. n = 622 sex: 42% men age: 43.5 years | RCT in general practice. FU 12 months (n = 502). Goals were at least one fruit, at least 200 g vegetables and at least 30 min PA per day. | Participants were offered 6 face-to-face sessions (30 min) and 3 monthly telephone sessions with trained nurses. Methods were based on motivational interviewing, problem solving treatment, theory of planned behaviour and theory of self-regulation. CG got brochures of health guidelines. | No significant results in weight or fasting glucose or glucose tolerance. Increase in fruit intake between baseline and 6 months (1.1 - > 1.3 pieces per day) but not after 12 months. Median participation in sessions was 2. (−) |
The Joetsu Diabetes Prevention Trial Japan Kawahara et al., 2008 [28] | 20–70 year old men and women IGT (ADA 2003) | Recruiting from 11 outpatient practices and health evaluation and promotion centres in Joetsu area. Patients with BMI 20–34 kg/m2 and FPG ≥ 5.6 mmol/l or HbA1C 5.2–6.4% were screened n = 426 sex: 47% men age: 51.4 years | Community-based clinical trial comparing short-term hospital (STH, n = 143) or outpatient diabetes education support (DES, n = 141) to no-treatment (n = 142). Mean FU 3.1 years. Goals for STH were 25–30 kcal / ideal body weight kg / day; 20–25% E% of fat; at least 30 min/day walking or exercise at least 5 times a week. Goals for DES were to follow diabetes guidebook. | STH group had 2-day hospital stay with a course of nine group/individual lessons covering diet, exercise and behaviour modification. Subsequent sessions every 3 months were offered individually. DES group got written information and 3-monthly individual sessions of a healthy lifestyle. Lessons were 20–40 min and were taught by different medical specialists. Mean intervention duration was 3 years. | The incidence of diabetes was 42 and 27% lower in STH and DES groups compared with no-treatment group, and 21% lower in STH than DES. Also FPG, 2 h OGTT plasma glucose, HbA1C and weight changes between groups were significantly different. STH) was more cost effective than DES ++ |
EDIPS-Newcastle UK Penn et al., 2009 [29] | > 40 years, BMI > 25 kg/m2, IGT in two OGTTs | Recruiting by invitation letter to eligible customers of primary care physicians. 1567 were contacted; 1084 replied; 682 agreed to testing; 482 completed at least one OGTT n = 102 sex: 41% men age: 57.1 years | RCT of two arms; intervention vs usual care. Mean FU 3.1 years (n = 42), up to 5 years > 50 E% carbohydrate; < 30 E% fat; reduce saturated fat intake; increase fiber intake; BMI < 25 kg/m2 | Approx. 24 sessions with dietitian and physiotherapist as individual motivational interviewing for behavioural changes, including feedback from food diaries, weight and waist measurements. Cooking groups and discount of leisure service card was offered. Quarterly newsletter containing recipes, nutritional info and exercise suggestion was sent. Control group got usual care. | Weight reduction was 2.3 kg in IG vs. no change in CG, p = 0.007 at year 1 but no significant difference in consecutive years. The overall incidence of diabetes was non-significantly reduced by 55% in the intervention-group vs. the control group, with RR 0.45 (95% CI 0.2 to 1.2). (+) |
PREDIAS Germany Kulzer et al., 2009 [30] | 20–70 years BMI ≥ 26 IGT or IFG | Invitations by primary care physician based on FINDRISC > 10. n = 182 sex: 57% men age: 56.3 | Two armed randomized control study in general practice. FU 12 months (n = 165). Goals based on DPP. | 12 × 90-min group lessons in 12 months. Program was based on self-management theory and delivered by diabetes educator or psychologist. Participants got an exercise book, with diabetes prevention information and worksheets for lessons. Control group got written information about diabetes prevention. | There was significant difference in weight loss (−3.8 ± 5.2 vs. − 1.4 ± 4.09 kg), reduction in fasting glucose, increase in duration of PA and changes in eating behaviour after 12 months between intervention and control group. + |
Telephone support in addition to Greater Green Triangle Diabetes Prevention Program Australia Dunbar et al., 2010 [31] | 40–75 years FINDRISC > 12 points | Participants who completed the 12 month diabetes prevention program and were willing to participate in follow-up. n = 205 sex: 28% men age: 56.6 years (self-care); 57.1 (telephone support) | Telephone support vs self-care after 1 year lifestyle intervention pretest-posttest study for next 18 months FU 30 months (n = 164) < 30 E% fat; < 10 E% saturated fat; > 15 g fibre/1000 kcal; > 4 h/week moderate PA; > 5% weight reduction | Telephone support started after 12 month original intervention consisting of 6 group sessions. Telephone group got up to 12 calls following semi-structured interview with questions regarding personal goals. | There wasn’t significant difference between telephone support and self-care group. Original interventions improvements in 12 months were generally maintained to 30 months in both groups. (−) for telephone support |
DE-PLAN, Greece Greece Makrilakis et al., 2010 [32] | FINDRISC ≥15 points | 3240 individuals were screened with FINDRISC-questionnaires; 620 were eligible. n = 191 sex: 40% age: 56.3 y | Pretest-posttest study in community setting in Greece. FU 12 months (n = 125) Reduce saturated and trans fat, sugars and sweets, refined cereals; ≥ 5 portions of fruits and vegetables per day; PA ≥ least 30 min 5 times a week. Weight reduction was recommended if overweight. | A dietitian held 6 group intervention sessions during 1 year. Each session was focused on one of goals and included information, discussion and written material. Sessions were held in workplaces or near participants’ residence. Evaluation of achieving goals was discussed in the beginning of each session. | Weight, BMI, blood pressure, and total cholesterol reduced significantly in those who completed program. Also reduction in whole fat dairies, processed meats, sugars and refined cereals was significant. + |
PREDIMED-Reus Spain Salas-Salvadó et al., 2011 [33] Martínez-González et al., 2012 [34] | Men 55–80 years; Women 60–80 years; At least 3 risk factors for cardiovascular disease: smoking; hypertension; dyslipidemia; BMI > 25 kg/m2; family history of cardiovascular disease | 1125 participants were screened in primary care centre and 870 fulfilled inclusion criteria. Of these 452 were diabetics, so 418 were the final population in this sub-study. n = 418 sex: 42% men age: 67 y | RCT for primary cardiovascular prevention in three arms: “low-fat” –control; Mediterranean Diet (MedDiet) + oil; MedDiet + nuts. Median FU 4 years. MedDiet; use olive oil abundantly; increase consumption of fruits, vegetables, legumes, nuts and tomato sauce for cooking; reduce total and red meat use and use fish and white meat instead; avoidance of butter, cream, fast food, sweets, pastries and sugar-sweetened beverages; moderate use of red wine. Control: reduce all type of fat, no free foods. All groups: No energy restriction, no PA promoted | Dietitians gave personalized dietary advice to participants on basis of a 14-item (MedDiet) or 9- item questionnaire (control). At inclusion and quarterly there after dietitians administered individual and group sessions. Participants were offered written material including descriptions of seasonal foods, shopping lists, weekly meal plans and cooking recipes. In addition participants in MedDiet groups were given free virgin olive oil (1 l/week) or nuts (30 g/day). | Hazard ratio for diabetes was 0.55 (0.32–0.95 95%CI) for both MedDiets compared with control diet in crude model and 0.48 (0.27–0.86) in multivariate adjusted model. Diabetes incidence was lower in participants who complied with the MedDiet better. Largest risk reduction was seen in MedDiet in subgroups of women vs men, over 67 year-old vs under and with those whose fasting glucose > 6.1 mmol/l in baseline than those who had ≤6.1 mmol/l. ++ |
DE-PLAN-Krakow Poland Gilis-Januszewska et al., 2011 [35] | FINDRISC points > 14; OGTT to exclude diabetics | Recruiting from primary health care centres. 566 completed questionnaire; 368 eligible; 275 underwent OGTT n = 186 sex: 22% men age: 56.1 y | Pretest-posttest study in primary health care in Poland FU 12 months (n = 175) Goals were weight loss, reduced intake of total and saturated fats, increased consumption of fruits, vegetables and fibre and increased PA. | Active phase of intervention consisted of 10 group sessions in first 4 months followed by 6-month maintenance with six motivational phone calls and two motivational letters. PA sessions were offered once or twice a week. Social and family involvement was encouraged. Prevention managers were educated. | Significant changes in weight, BMI and waist circumference. No significant changes in fasting glucose or glucose tolerance test results. + |
Making the Connection Healthy Living Program, MTC HLP USA Ruggiero et al., 2011 [36] | underserved latino population; age 18–65 years; BMI > 24.9, normal glucose or prediabetes; Latin background | Community-based health screening events (schools, family centers, hospital etc). 1162 screened, 367 tested for eligibility, 244 eligible. n = 69 sex: 7% men age: 38 y | Single-group, non-randomized follow-up, community-based translation of DPP. FU 12 months (n = 57). DPP goals: Weight reduction 7%; Diet: fat 25 E% Physical activity (e.g. brisk walking) 150 min/week | Culturally specific intervention was developed and conducted in collaboration with the community to minimize barriers to participation education, literacy, language, income, transportation, lack of medical coverage. 22 group sessions during 1 year, delivered by trained community health workers. Cook books, pedometer, scales provided. Group walks arranged. Participants attended 57% of group sessions. | At 6 m, 20% achieved 7% weight reduction, and at 12 m 16% achieved. Moderate improvements in body weight (− 4.8 kg at 6 m, − 2.8 at 12 m), waist, fruit and vegetables, fat intake, PA were observed at 6 m but attenuated at 12 m. Forward movement in “stages of change” scale was observed. + |
The Prevention of Diabetes and Obesity in South Asians: PODOSA UK Bhopal et al., 2014 [37] Douglas et al., 2013 [38] Douglas et al., 2011 [39] | South Asian families living in UK > 35 years; IGT and/or IFG | Recruiting via National health service, South Asian organizations and peer to peer. Pre-screening by waist circumference. 1319 screened with an OGTT, 196 (15%) were eligible. n = 171 (156 families) sex: 45.6% men age = 52.5 y | Family-based two armed RCT in South Asians living in UK FU 3 years Goals were calorie deficit diet, at least 30 min brisk walking per day and at least 2.5 kg weight reduction. | Intervention visits were done in participants’ homes, 15 for intervention group and 4 for control group in 3 years. Practical dietary counselling: cooking, food shopping, food labelling and recipes. Counterweight program was used to dietary counselling. Change management tools, self-reflection and cultural adaptations were included. | Weight change in the IG was − 1.13 kg (SD 4.12) and in CG + 0.51 kg (SD 3.65), an adjusted mean difference of − 1.64 kg (95% CI − 2.83 to − 0.44).No difference in changes of fasting plasma glucose, OGTT or physical activity. Progression to diabetes was observed less frequently in the IG than the CG (OR 0·68) but not statistically significant (p = 0·3705). (+) |
Zensharen Study for Prevention of Lifestyle Diseases Japan Saito et al. 2011 [40] | 30–60 years; BMI > 24 IFG | First screening from health check-ups and eligible people were invited to OGTT (diabetics were excluded). n = 641 sex: 78% men age: median 50 y in IG, 48 y in CG | Unmasked, multicenter RCT in health care setting: frequent intervention group (FINT n = 311) vs. control (n = 330). FU 36 months (n = 562). Goals: 5% weight loss; reduce total energy intake; fat 20–25 E%; carbohydrate 55–60 E%; increase fibre intake and moderate alcohol intake. Increase of incidental PA to 200 kcal/d. | FINT got individual instructions and follow-up support for lifestyle modification from mainly dieticians and nurses at least 9 times. Self-monitoring using pedometers and body weight recording sheets. Control group got similar individual instruction 4 times during first 12-months without follow-up support or self-monitoring tools. | The HR for T2D in FINT was 0.56 (95% CI 0,36-0,87) compared to control. In FINT IFG only group HR was 1.17 (0.50–2.74), and in FINT IFG + IGT 0.41 (0.24–0.69), compared to corresponding CGs. > 5% weight loss was significantly more achieved in FINT group during the first 12 months. Also PA goals and reducing energy intake goal were achieved more in FINT group. ++ |
APHRODITE The Netherlands Vermunt et al., 2011 [41] Vermunt et al., 2012 [42] Vermunt et al., 2012 [43] | FINDRISC ≥13; age 40–70 years | FINDRISC-questionnaire was sent to GP patients from 14 primary care practices (n = 16,032). Individuals with a score ≥ 13 were invited (n = 1533) for OGTT and diabetics were excluded. n = 925 sex: 38% men age: 58 y | RCT in Dutch primary care (IG n = 479, CG n = 446) FU 2.5 years (IG n = 368, CG n = 341) Weight reduction ≥5% if overweight, PA for at least 30 min a day / 5 days a week, fat intake < 30 E% and saturated fat < 10 E%, dietary fibre intake ≥3.4 g per MJ | Participants were offered 11 individual sessions with nurse or general practitioner, one with dietitian and 5 group sessions with dietitian and physiotherapist. Intervention lasted 30 months. Dietary advices were based on food diary. The intervention was based on trans-theoretical model (the stages of change). | Differences between groups were significant only for total physical activity and saturated fat and fibre intake. In the intervention group, self-efficacy was significantly higher in individuals successful at losing weight compared with unsuccessful individuals. (+) |
Lawrence Latino Diabetes Prevention Project (LLDPP) US, Massachusets Ockene et al., 2012 [44] | Low-income latinos 25–79 y old latino / hispanic ethnicity; ≥ 25 y old; BMI > 24; > 30% increased according T2D risk algorithm | Recruiting (n = 949) from local health centre and local media. n = 312 FU: 289 (CG 142, IG 147) sex: 25.6% men age: 52 y | Randomised community-based, culturally tailored, literacy sensitive lifestyle intervention (n = 162) vs. usual care (n = 150). FU 1 year (n = 289) Increase intake of whole grains and vegetables; reduce sodium, total and saturated fat, portion sizes and intake of refined carbohydrates and starches; increases walking by 4000 steps/day | 3 individual sessions at home (1 × 1 h, 2 × 0.5 h) and 13 group sessions (1 × 1.5 h, 12 × 1 h) over 12-month period. Participants got cash incentives at baseline, at 6- and 12-months. Participation was maximized with compensatory sessions and home visits. Practical, hands-on methods and demonstrations were used. Intervention was based on social cognitive theory and patient-centred counselling. | Participants lost more weight in IG (−2.5 lb) than in CG (+ 0.63 lb), effect of intervention − 2,5 lb. (p = 0.004). Also HbA1c reduced more in IG vs CG (effect of intervention − 0.10%, p = 0.009). Participants in IG reduced more energy intake from fat and saturated fat and increased dietary fibre intake. + |
E-LITE US Xiao et al., 2013 [45] Ma et al., 2013 [46] | ≥ 18 years BMI ≥ 25; IFG or metabolic syndrome (2005 AHA) | Recruiting from a primary care clinic: 3439 contacted, 752 screened BL n = 241 (81 cont; 79 coach-led; 81 self-directed) sex: 53% men age: 52.9 | RCT in primary care with three arms: control, coach-led group intervention vs. self-directed DVD intervention. FU 15 months (n = 221) Weight loss goal based on DPP | Intensive intervention (3 months) included 12-session in groups or at home via DVD. Coach-led group had food tasting and guided PA and self-directed group got one face-to-face session, weight scale, pedometers and biweekly reminder e-mails during 12 month maintenance phase. All intervention participants were trained to use self-monitoring web portal. | At month 24 the mean change in BMI from baseline was −1.9 +/− 0.3 kg for coach-led group (p = 0,001 vs CG); − 1.6 +/− 0.3 kg for self-directed group (p = 0.003) and − 0.9 +/− 0.3 in the control group. Fasting plasma glucose was significantly more improved in IGs compared to CG. + |
RCT of SMS for Drivers With Pre-DM China Wong et al., 2013 [47] | Professional drivers IFG/IGT; had a mobile phone | Screened 3376 drivers identified by community screening and media advertisement. n = 104 subjects age: 53 y sex: 93.3% men | RCT of short message service (SMS) intervention on vs. control (leaflet) FU 24 months (IG n = 41;CG n = 29). “Diabetes-related information in reducing the risk of developing diabetes” | Participants got sms from 4 themes: diabetes information; lifestyle change; how others would appreciate the lifestyle modification; self-efficacy enhancing statements. In the first 3 months sms were sent 3 times a week, next 3 months weekly and last 18 months monthly. Both groups got leaflets about diabetes. Intervention was based on theory of planned behaviour and social cognitive theory. | No significant reduction in diabetes risk after 12 or 24 months. Significant mean differences in diastolic blood pressure and HDL-cholesterol over time between the groups. Intervention cost was 5.05 $/ subject (−) |
DH!AAN The Netherlands Admiraal et al., 2013 [48] Vlaar et al., 2012 [49] | South Asian migrants Age 18–60 y; IFG, IGT, HbA1c > 6.0% or HOMA-IR > 2,39 | 2307 screened via general practices (invitation letter with reply card), followed by reminder and telephone call). n = 536 age: 44.9 y sex: 49.4% men | RCT in general practice among South Asian migrants in Netherlands getting a culturally targeted intervention or generic lifestyle advice (control). FU 2 years (n = 335). Goals according to SLIM study; based on current guidelines on diet and physical activity. | 6–8 individual sessions in general practice during 6 months, 2 sessions during the next 6 months + 1 family session + two cooking classes. 20-week supervised exercise program was offered. Trained dieticians gave dietary counselling using motivational interviewing. Participants got a gift coupon for participating in baseline measurements. Control arm got 2 group sessions + 2 flyers. | No significant results. Median participation in 5 individual sessions. High drop-out and low participation 26% participated in family session, 26% in cooking sessions and 22% in PA sessions. (−) |
“Group Lifestyle Balance™ program in the community setting USA Kramer et al. 2014 [50] | 26–80 years old BMI ≥ 25 kg/m2; IFG / metabolic syndrome; ≥ 25 years old | Recruiting via GPs, information letters, e-mail contact and newspaper advertisement. n = 81 sex: 22% men age: 52.9 y | Group Lifestyle Balance (GLB) program in three outpatient-hospital in a pretest-posttest setting. FU 12 months (n = 52) 7% weight loss; 150 min PA/week | 12-session group lifestyle intervention adapted from DPP delivered by trained diabetes educators in groups over 12 to 14 weeks and monthly thereafter. Each session lasted 1 h. Handouts, self-monitoring booklets, fat- and calorie-tracking book and a pedometer were given to participants. | Significant changes: weight loss was 5.1% (p < 0,001); decrease in waist circumference; fasting plasma glucose; LDL-cholesterol; triglycerides and blood pressure. + |
Subanalysis of the Japan Diabetes Prevention Program Japan Sakane et al., 2014 [51] | 30–60 years IGT | People measured in yearly health check-ups were recruited using posters, fliers and by word of mouth. 1279 were screened with OGTT. n = 304 sex: 50,0% men age: 59% men | RCT in 32 primary health care centres using existing resources in two arms. mean FU 2.3 years (n = 213) 5% reduction in body weight in overweight and obese; increase energy expenditure by 700 kcal per week; < 25 E% fat; < 160 kcal/day from alcohol | Study nurse held four 2–3-h group sessions during first 6 months followed by biannual 20–40 min individual sessions, intervention was 3 years. After first year individual sessions were held on phone. Personalised goals were set. A booklet was given and monthly tip cartoons were sent via fax. Self-efficacy, self-monitoring and trans-theoretical model was used. | No significant results in T2D risk. In IG participants with BL HbA1c levels ≥5.7% (n = 177) cumulative incidence was significantly lower. Significant results: at 1 year IG had improved body weight and daily non-exercise leisure time energy expenditure and at 3 years better Matsutada index. (+) |
Use of Information Technology in the Prevention of Diabetes India Nanditha et al., 2014 [52] Ramachandran et al., 2013 [53] | Men No major illness; age 35–55 years; positive family history of T2D; BMI > 23; IGT | First screening with questionnaire (n = 8741) and then OGTT first with a glucometer and confirmatory venous blood glucose within 1 week. n = 537 sex: 100% men age: 46 y | RCT in industrial male workers lifestyle modification with SMS. FU 2 years (n = 517) Avoidance of simple sugars and refined carbohydrates; total fat intake < 20 g/day; restrict use of saturated fat; increase fibre; enhance aerobic exercise > 30 min brisk walk/day; walk 3–4 km in 30 min at least 5 days a week | All participants got personalised lifestyle modification in the beginning. SMS-group received mobile phone messages at frequent intervals (2–4 sms/week). SMS content was tailored according to participant’s stage of change in trans-theoretical model. | Risk reduction in sms-group compared to control was 9% (HR = 0.64 CI 0.446–0.917 p = 0.015). ++ |
“Lifestyle modifications in Chinese women who had gestational diabetes mellitus” China Shek et al., 2014 [54] | Age > 18 years; GDM history; IGT 6–8 weeks after delivery; excluded if insulin for GDM | Patients from hospitals were invited if criteria were fulfilled n = 450; sex: 100% women age: 39 y | RCT conducted in hospital in Hong Kong. Intensive lifestyle intervention vs. no intervention (control). FU 36 months (n = 423). Optimal caloric intake (based on Harris-Benedict) for ideal body weight | 7 individual sessions in 3 years (3 m, 6 m 12 m, 18 m, 24 m 30 m, 36 m). Dietician and study nurse gave individual dietary and exercise advice based on food and exercise records (n = 7). | No significant difference in cumulative incidence of diabetes. In women > 40 years, difference between groups was significant. Significant differences between groups at 1 year in BMI and waist-hip ratios, but not significant in the end of the study. (+) |
“Prevention of diabetes in Finnish airline” Finland Viitasalo et al., 2012 [55] Viitasalo et al., 2015 [56] | Airline workers (majority shift-work) FINDRISC > = 10 or IFG or IGT | Occupational health care check-up n = 2312, 657 had high risk and were offered intervention. n = 350 sex: 60% men age: 47 y | Work-site study targeted at identified high-risk workers of an airline. Average FU 2.5 years (n = 402). DPS goals and other goals according to risk factor levels (BP, cholesterol). | 1–3 individual lifestyle counselling sessions in addition to the check-up by nurse/physician. Lifestyle sessions were delivered by diabetes nurse or nutritionist. | Among elevated risk men, body weight was slightly reduced and 14.3% lost > 5% of weight, and cholesterol and LDL decreased. Those men who attended more lifestyle sessions lost more weight. Fasting glucose increased in all groups. FINDRISC score increased, but less so among high-risk men. (+) |
Study | Reach | Implementation & adaptation | Efficacy & maintenance | ||
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Name/ acronym Country Reference | Target group, age range/mean | Screening and recruitment; attrition | Study design, lifestyle goals/targets | Intervention delivery | Results Clinical significance estimate* |
Daqing Diabetes Prevention Study China Pan et al., 1997 [5] Li et al., 2008 [15] | People living in Daqing area, > 18 y old IGT | 110,660 people screened with OGTT 577 randomized sex: 54% men age: 45 ± 9 y | Cluster randomized controlled study in four groups: control, diet only, physical activity (PA) only, or diet + PA FU 6 years (n = 533) + 20 years. Goals: Diet (increase vegetables, decrease alcohol and sugar, caloric and weight reduction if overweight), PA (1–2 units/day; e.g. 30 min of slow walking etc.) | Individual counselling + compliance evaluation by physician/nurse every 3 months + small groups weekly for 1 month, monthly for 3 months and every 3 months thereafter. Intervention duration was 6 years. | HRs (adjusted for baseline BMI and f-Glu): HR = 0.69 for diet vs CG, p < 0.03; HR = 0.54 for diet + PA, p < 0.0005; 0.58 (diet+PA), p < 0.005; HR = 0.41 for PA vs CG p < 0.0005. The average number of PA units per day was higher after 6 years. ++ |
Hoorn Prevention Study The Netherlands Lakerveld et al., 2012 [26] Lakerveld et al., 2013 [27] | Age 30–50 At least 10% risk for T2D and/or CVD estimated according formula of ARIC and SCORE projects. | A screening invitation to GP customers (n = 8193). 2401 respond, 921 eligible based on waist circumference. 772 were screened. n = 622 sex: 42% men age: 43.5 years | RCT in general practice. FU 12 months (n = 502). Goals were at least one fruit, at least 200 g vegetables and at least 30 min PA per day. | Participants were offered 6 face-to-face sessions (30 min) and 3 monthly telephone sessions with trained nurses. Methods were based on motivational interviewing, problem solving treatment, theory of planned behaviour and theory of self-regulation. CG got brochures of health guidelines. | No significant results in weight or fasting glucose or glucose tolerance. Increase in fruit intake between baseline and 6 months (1.1 - > 1.3 pieces per day) but not after 12 months. Median participation in sessions was 2. (−) |
Zhiiwapenewin Akino’maagewin: Teaching to Prevent Diabetes, ZATPD Canada Ho et al., 2008 [57] | Native North Americans Native North Americans (=high T2D risk), non-pregnant, living in the community at least 30 days. | Screening from the community, IG n = 57, CG n = 38. n = 133 sex: 22% men age: 42 y | Non-random assignment of communities into intervention/ comparison FU 12 months (n = 95). Improve dietary choices (reduce fat and sugared drinks) and physical activity by increasing knowledge, self-efficacy, and attitudes. | Intervention was based on social cognitive theory of behaviour change and implemented in three components. School component with 16 + 17 sessions lead by teacher; children as “change agents”. Store component to support more appropriate foods. Community component, media involvement, cooking demos, community events, family fun nights in collaboration with existing health and social services. | Higher healthy food acquisition scores after intervention; no change in healthiness of food preparation scores. No change in BMI, decrease in PA in both groups (+) |
Making the Connection Healthy Living Program, MTC HLP USA Ruggiero et al., 2011 [36] | underserved latino population; age 18–65 years; BMI > 24.9, normal glucose or prediabetes; Latin background | Community-based health screening events (schools, family centers, hospital etc). 1162 screened, 367 tested for eligibility, 244 eligible. n = 69, sex: 7% men age: 38 y | Single-group, non-randomized follow-up, community-based translation of DPP. FU 12 months (n = 57). DPP goals: Weight reduction 7%; Diet: fat 25 E% Physical activity (e.g. brisk walking) 150 min/week | Culturally specific intervention was developed and conducted in collaboration with the community to minimize barriers to participation education, literacy, language, income, transportation, lack of medical coverage. 22 group sessions during 1 year, delivered by trained community health workers. Cook books, pedometer, scales provided. Group walks arranged. Participants attended 57% of group sessions. | At 6 m, 20% achieved 7% weight reduction, and at 12 m 16% achieved. Moderate improvements in body weight (− 4.8 kg at 6 m, − 2.8 at 12 m), waist, fruit and vegetables, fat intake, PA were observed at 6 m but attenuated at 12 m. Forward movement in “stages of change” scale was observed. + |
Families United USA Perez Siwik et al., 2012 [58] Kutob et al., 2014 [59] | Families with risk for T2D Diabetes risk factor (BMI > 25, inactivity, family history, etc.), no T2D, not pregnant, able to participate in group sessions | Community and clinic-based recruitment, 164 were interested, 108 screened n = 29 (+ 29 support people) sex: 26% men age: 45 | Pretest-posttest study. Family-based intervention based on DPP. A household member/friend accompanied in the sessions. FU 12 months (n = 18) DPP goals (7% weight reduction, 150 min of PA/week); reduction in portion sizes and carbohydrates, especially sugared beverage, fat and fast food. | Patient-centered, multiculturally tailored intervention to elicit participants’ explanatory models regarding their diabetes risk. Physician+dietician delivered 12 group visits every 2 weeks over 6 months + 2 booster sessions. Cognitive behavioural approach aimed at increasing resilience (flexible thinking) skills. 15 min PA during each session. Attendance rate was 72% for the finishers. | Outcome measures were reduction in the total number of predefined diabetes risk factors (BMI, WC, BP, HbA1c, Insulin, GI, PA). Number of predefined risk factors reduced from 4.8 to 4.1 at 6 months and to 3.4 at 12 months, primarily due to reduction in GI and fasting insulin. + |
“Diabetes prevention program in public housing communities” USA Whittemore et al., 2013 [60] Whittemore et al., 2014 [61] | People living in low-income public housing communities age > 21 y, 2 or more T2D risk factors (overweight, age, family history) | Convenience sample in 4 rural public housing communities. n = 67, sex: 79% female age: 40 y | Cluster-randomized implementation of DPP in low-income public housing communities. Enhanced standard care vs. mDPP, n = 67, diverse ethnicity (aim n = 100). FU 6 months (n = 48) DPP goals: Healthy eating plan, reduced calories, weight reduction 5–10%, physical activity 150 min/week | DPP program modified after focus groups. Two homecare nurses (8 h training) implemented the program and local community health workers (4 h training) assisted. IG got 7 interactive education classes during 6 months based on behavioural support on goal-setting, self-monitoring; problem-solving + gift-card raffles. CG got written information + two interactive education classes | No changes in body weight or other clinical risk factors, or behavioural or psychological outcomes. (−) |
DH!AAN The Netherlands Admiraal et al., 2013 [48] Vlaar et al., 2012 [49] | South Asian migrants Age 18–60 y; IFG, IGT, HbA1c > 6,0% or HOMA-IR > 2.39 | 2307 screened via general practices (invitation letter with reply card), followed by reminder and telephone call). n = 536 age: 44.9 y sex: 49.4% men | RCT in general practice among South Asian migrants in Netherlands getting a culturally targeted intervention or generic lifestyle advice (control). FU 2 years (n = 335). Goals according to SLIM study; based on current guidelines on diet and physical activity. | 6–8 individual sessions in general practice during 6 months, 2 sessions during the next 6 months + 1 family session + two cooking classes. 20-week supervised exercise program was offered. Trained dieticians gave dietary counselling using motivational interviewing. Participants got a gift coupon for participating in baseline measurements. Control arm got 2 group sessions + 2 flyers. | No significant results. Median participation in 5 individual sessions. High drop-out and low participation 26% participated in family session, 26% in cooking sessions and 22% in PA sessions. (−) |
“Lifestyle modifications in Chinese women who had gestational diabetes mellitus” China Shek et al., 2014 [54] | Age > 18 years; GDM history; IGT 6–8 weeks after delivery; excluded if insulin for GDM | Patients from hospitals were invited if criteria were fulfilled n = 450; sex: 100% women age: 39 y | RCT conducted in hospital in Hong Kong. Intensive lifestyle intervention vs. no intervention (control). FU 36 months (n = 423). Optimal caloric intake (based on Harris-Benedict) for ideal body weight | 7 individual sessions in 3 years (3 m, 6 m 12 m, 18 m, 24 m, 30 m, 36 m). Dietician and study nurse gave individual dietary and exercise advice based on food and exercise records (n = 7). | In women > 40 years the difference in cumulative incidence of diabetes between groups was significant. Significant differences at 1 y measurements in BMI and waist-hip ratios, but not significant at 3 y in the end of the study. (+) |
Dulce Mothers USA Philis-Tsimikas et al., 2014 [62] | Low-SES Latinas Latina, 18-45y, GDM during past 3 years | 263 contacted by information from medical records, 193 met criteria, 102 consented and came to lab n = 84 sex: 100% women age: 31.9 y | Single-group, pretest-posttest 6 m follow-up (n = 70) DPP goals: Weight reduction 7%, diet: fat 25 E%, physical activity (e.g. brisk walking) 150 min/week (700 kcal/week) | Condensed DPP based on social cognitive theory; trained peer educator lead educational group sessions, 8 sessions/8 weeks (core intervention) + additional monthly maintenance sessions e.g. weekly healthy lifestyle goals that involve the family members + discussions about culturally driven fatalistic health beliefs, mean attendance in 6 out of 8 sessions | No significant weight loss; however correlation between attendance and weight reduction. HbA1c increased slightly (5.73- > 5.82). Moderate improvement in cholesterol, LDL, triglyserides and diastolic BP. (+) |
Study | Reach | Implementation & adaptation | Efficacy & maintenance | ||
---|---|---|---|---|---|
Acronym / Name of study Country References | Target group, Inclusion criteria | Screening, recruitment, study population (n, sex, mean age) | Study design, follow-up (FU) duration, lifestyle goals/targets | Intervention delivery, intervention duration, change theories | Results Clinical significance estimate* |
Reaching Out and Preventing Increases in Diabetes (RAPID) USA Ackermann et al.,. 2014 [63] Ackermann et al., 2015 [64] | Economically disadvantaged adults ≥18 years old, BMI ≥ 24 kg/m2, no prior T2D, HbA1c level 5.7–6.9% or FPG > 100–125 mg/dl | 12,787 patients were identified from 9 primary care clinic database; 3064 identified as high risk by primary care glucose tests; 640 attended screening visit. n = 509 (n = 252 for CG and n = 257 for IG) sex: 29.3% men age: 50.8 ± 12.2 y | Community-based randomized trial in economically disadvantaged adults. 2 groups: standard clinical advice plus a group-based adaption of the DPP offered by the YMCA, versus standard clinical advice alone. Follow-up: 12 months. Weight loss of 5–7%; moderate physical activity; lower dietary fat and total calorie consumption. | 16 classroom-style behavioural counselling meetings, lasting 60 to 90 min and delivered over 16 to 20 weeks. Following monthly 60-min maintenance lessons until the end of the trial. YMCA offered limited guest-access and tools such as a step counter, measuring cups, fat and calorie tracking tools and recipe guides. Intervention was based on the DPP and included Goal-setting, self-monitoring and participant-centred problem solving. | Mean 12-month weight loss was 2.3 kg (95%CI: 1.1 to 3.4) more for the intervention arm than for standard care. Participants attending ≥9 lessons had a 5.3-kg (95% CI: 2.8 to 7.9) greater weight loss than did those with standard care alone. No significant differences in HbA1c, systolic blood pressure, HDL cholesterol or total cholesterol at 12 months. (+) |
Diabetes mellitus and abnormal glucose tolerance development after gestational diabetes Spain Pérez-Ferre et al., 2015 [65] | Women with prior gestational diabetes Prior GDM, normal fasting glucose at 6–12 weeks postpartum | 300 were invited n = 260 were included (130 in IG and 130 in CG) sex: 100% women age: 35 y (range 31–38 y) | RCT in a hospital setting, Mediterranean lifestyle intervention vs. control. Follow-up: 3 years (n = 237, 126 in IG and 111 in CG) For both groups: Mediterranean diet, physical activity and smoking cessation. Goals for IG: ≥5 servings (svgs) fruits and vegetables /day, > 2 svgs legumes/week, > 3 svgs nuts / week, daily use of virgin olive oil, ≥3 svgs oily fish / week, < 2 svgs red and processed meat / week and < 2 svgs non-skimmed dairy products / week. | Intervention group: 2-h group session at the 1st visit + 5 individual reinforcement sessions (45-min) at the hospital + supervised exercise program: group and individual sessions (1-h, 4 days per week) for 10 weeks 3–6 months post-delivery and 3 reinforcement sessions. Exercise: intensive supervised program. Control group: 2-h group session at the 1st visit and 3 annual follow-up visits. | Less women in the IG (42.8%) developed glucose disorders compared with the CG (56.7%), p < 0.05. Also significant reductions in BMI, waist circumference, insulin, HOMA-IR, LDL-cholesterol, triglycerides and Apo lipoprotein B in the IG compared with the CG. ++ |
Fit Body and Soul (FBAS) Study USA Dodani et al., 2009 [66] Williams et al., 2013 [67] Sattin et al., 2016 [68] Rhodes et al., 2018 [69] | African-American in Georgia area Age 20–64 years, self-described African American, BMI ≥25 kg/m2, no plans for moving, non-diabetic | Study- trained church health advisors distributed flyers to church members and made scripted-podium announcements to promote the study. 710 subjects from 20 churches located in a Georgia metropolitan area consented. n = 604 (n = 317 for IG and 287 for health education). | Single-blinded, cluster-randomized trial in African Americans. 2 groups: Fit Body and Soul intervention vs. health education (control). Follow-up: 12 months. Faith-based adaptation of the Group Lifestyle Balance program: weight reduction of ≥7% of initial weight and physical activity of ≥150 min per week of brisk walking. | Fit Body and Soul: The church health advisors held 12 weekly sessions comprised strategies to reduce calories and dietary fat, encourage physical activity, and behavioural modification such as stimulus control, goal setting, and problem solving followed by 6 monthly sessions. Health advisors phoned participants to review food and activity log and use scripted motivational interview messages to address participant barriers to lifestyle changes. Health education: 12 weekly sessions and then 6 monthly sessions, delivered by church health advisors including group discussion regarding health topics. | At 12 months, IG had a significant difference in adjusted weight loss compared with health education (2.39 kg vs. − 0.465 kg, p = 0.005) and were more likely to achieve a 7% weight loss (19% vs. 8%, p < 0.001). Fasting glucose did not differ between arms. In analyses with prediabetics only IG had a significant decline in fasting glucose compared to CG (− 12.38 mg/dl vs. + 4.44 mg/dl; p = 0.02). Per-person intervention cost was $442.22 for IG vs. $391.83 for CG per-person. + |
Gestational Diabetes’ Effects on Moms (GEM) study USA Ferrara et al., 2014 [70] Ferrara et al., 2016 [71] | Women with GDM history Age ≥ 18 years, GDM diagnosis. | 2480 identified; n = 2.280 (1087 in lifestyle intervention and 1.193 in usual care). sex: 100% women | Pragmatic cluster RCT of 2 groups in 44 medical facilities at Kaiser Permanente Northern California. Follow-up: 12 months (n = 1420). Reaching pregravid weight if pregravid BMI < 25 kg/m2 or losing 5% of pregravid weight if their pregravid BMI ≥ 25 kg/m2. | Intervention: 13 telephone sessions between 6 weeks and 6 months postpartum. Women were encouraged to set weekly goals for daily fat and caloric intake and to work up to 150 min of PA per week. Motivational interviewing and theoretical constructs from social cognitive theory and the transtheoretical model were used. 3 maintenance newsletters were mailed during 7–12 months post-partum. Usual care: 2 pages of lifestyle recommendations sent via mail. | IG had a 28% higher odds (95%CI: 1.10–1.47) of meeting postpartum weight goals than CG. Women who completed all 13 sessions had double odds (OR: 2.16, 95%CI: 1.52, 3.07). Fewer women in the IG developed prediabetes or diabetes than in CG. However, HR for did not reach statistical significance.+ |
Fair Haven Community Health Center’s Diabetes Prevention Program USA Van Name et al., 2016 [72] | Low-income Hispanic women Age 18–65 years, ≥ 1 risk factor for diabetes, OGTT. | 1093 women identified as being at risk; 383 had prediabetes in OGTT. n = 130 age: 43 y sex: 100% women | RCT of 2 groups in low-income Hispanic women in Fair Haven community health centre Follow-up: 12 months (n = 122) Based on Diabetes Prevention Program: 7% weight loss (decreasing dietary fat and caloric intake) and ≥ 150 min per week of moderate-level physical activity. | IG: Family-centred 14-week group program with 1-h lifestyle class per week focusing on healthy food choices, behaviour change and weight loss led by a trained bilingual nurse. The curriculum was enhanced for a population with lower literacy with a hands-on learning approach including weekly cooking demonstrations, group learning sessions at the local grocery store, and encouragement to participate in the neighbourhood community farm. CG: 1 diabetes prevention counselling with nurse and dietitian. | The intensive intervention group lost 3.8 kg (4.4%), while the usual care group gained 1.4 kg (1.6%, p < 0.0001). 2-h glucose excursion decreased 15 mg/dL (0.85 mmol/L) in the intensive intervention group and 1 mg/dL (0.07 mmol/L) in the usual care group (p = 0.03). Significant decreases favoring intervention were also noted in BMI, percent body fat, waist circumference, and fasting insulin. + |
Community-based HEalthy Lifestyle intervention Program (Co-HELP) Malaysia Ibrahim et al.,2016 [73] | 18–65 years old, able to read and understand Malay or English, fasting blood glucose 5.6–6.9 mmol/L, and/or 2-h glucose 7.8–11.0 mmol/L in 75 g OGTT, BMI 23–39 kg/m2 | Recruiting from the general population through healthcare providers and presentations at community-halls, mosques, and media. 685 were screened n = 268 (IG n = 122; CG n = 146) sex: 35.8% men age: 53 y | Quasi-experimental study with repeated measures, conducted in two sub-urban communities. 2 groups: intensive lifestyle intervention vs. standard care. Follow-up: 12 months (n = 236) Reduction of 5–10% of initial body weight for overweight and obese participants, reduction of calorie intake (20–25 kcal/kg body weight) and an increase from light to moderate physical activity (≥ 600 METs-minute/week). | IG received 12 90-min group sessions and ≥ 2 individual sessions with a dietitian and a researcher to reinforce behavioural change over 12 months. Sessions were first held more intensively (9 sessions /6 months) followed by 6 months maintenance phase with 3 monthly sessions (Sessions 10–12) and follow up through telephone calls or home visits for the last 3 months. Other group got standard care in primary health care. | IG mean fasting glucose reduced by − 0.40 mmol/l (p < 0.001), 2-h post glucose by − 0.58 mmol/l (p < 0.001), HbA1C by − 0.24% (p < 0.001) and waist circumference by − 2.44 cm (p < 0.05). Greater proportion of IG met the weight loss target (24.6% vs. 3.4%, p < 0.001) and physical activity of > 600 METS/min/wk. (60.7% vs. 32.2%, p < 0.001) compared to the CG. + |
Lifestyle Modification in Information Technology (LIMIT) India Limaye et al., 2017 [74] | Employees in 2 IT industries ≥3 diabetes risk factors (family history of cardio-metabolic disease, overweight, high BP, IFG, high triglycerides, high LDL, low HDL). | 437 employees in 2 multinational IT industries in Pune (India) were screened n = 265 (132 in CG and 133 in IG); age: 36.2 ± 9.3 | RCT in 2 groups: Technology based lifestyle intervention Follow-up: 1 year (n = 203) 5% weight loss for overweight/obese; 4 lifestyle modification goals: exercise ≥150 min/week, intake of giber-rich foods ≥8 servings/week, intake of calorie-dense foods ≤4 servings/week and smoking cessation. | Before randomization, all participants attended a 1-h group session on lifestyle modification. Intervention group: information on lifestyle modification through 3 mobile phone messages and 2 e-mails per week for 1 year. Additional support was provided through a website and a Facebook page. | The prevalence of overweight/obesity reduced by 6.0% in the IG and increased by 6.8% in the CG (risk difference 11.2%; 95% CI: 1.2–21.1; P = 0.04). There were also significant improvements in lifestyle habits, waist circumference, and total and LDL cholesterol in the IG. + |
Promotora Effectiveness Versus Metformin Trial (PREVENT-DM) USA Perez et al., 2015 [75] O’Brien et al., 2017 [76] | Socioeconomically disadvantaged Hispanic females in Philadelphia Hispanic, female, age ≥ 20 y, Spanish-speaking, BMI ≥23 kg/m2, prediabetes* | 573 women contacted in community health fairs and at community health centers; 441 were at high risk (ADA score ≥ 4); 197 were screened; n = 92 (33 lifestyle, 29 metformin and 30 control); sex: 100% women age: 45.1 ± 12.5. | RCT in socioeconomically disadvantaged Hispanic women (Latinas). 3 groups: lifestyle intervention vs. metformin vs. control. Follow-up: 12 months (n = 65, lifestyle 30, metformin 27 and CG 28) Goals based on DPP: 5–7% weight loss by improving dietary patterns (decreasing fat and calorie consumption) and promoting moderate physical activity (≥150 min per week). | Group-based adaptation of the DPP intervention delivered by community health workers over 24 sessions (group size 5–9 participants, sessions lasting approx. 90 min). The first 14 sessions occurred weekly, and the final ten sessions took place biweekly and then monthly. Behavioural strategies such as goal setting, self-monitoring, stimulus control, and problem solving were used. Participants were provided with a digital scale, pedometer, measuring cups, and logs for tracking dietary intake and physical activity. | Post-hoc pairwise comparisons were significant for weight loss in lifestyle vs. standard care groups (−4.8 kg, p < 0.001) and lifestyle vs metformin (− 3.1 kg, p = 0.013), but not for metformin vs. standard care (− 1.7 kg, p = 0.3). Reduction in waist circumference was significantly greater in lifestyle than the standard care group (p = 0.001). Differences among groups in HbA1c did not reach statistical significance (p = 0.063). + |
Diabetes Prevention Program - Group Lifestyle Balance (DPP-GLB) in community centers USA Kramer et al., 2018 [77] | Age ≥ 18 y, BMI ≥24 kg/m2, presence of prediabetes* and/or the metabolic syndrome | 281 were screened n = 134 were enrolled; age: 62.5 | Before-after study in 3 senior/community centers. Follow-up: 12 months and to 18 months (n = 118 at 12 months; n = 107 at 18 months) Goals Based on the DPP: 7% weight loss and increase physical activity to 150 min/week. | The Group Lifestyle Balance Program included 22 sessions delivered over a 1-year period (12 weekly sessions transitioning to monthly sessions) led by a lifestyle coach. Lifestyle coaches (2 registered dietitians and an exercise specialist) completed a standardized 2-day training workshop. A DVD of the initial 12 sessions, was developed to provide an additional option for program delivery. | At 12 months, a significant decrease in mean weight loss of, along with improvements in HbA1c, insulin, blood pressure and physical activity level. At 18 months significant improvements in mean weight waist circumference and physical activity. + |
Prevention of Diabetes in Euskadi (Pre-DE) Spain Sanchez et al., 2012 [78] Sanchez et al., 2016 [79] Sanchez et al., 2018 [80] | Age 40–75 years; FINDRISC ≥14; high risk according OGTT. | 14 primary health centres selected; 66,293 individuals identified; 4170 screened; 2128 at risk for diabetes; 1314 had OGTT n = 1088 enrolled (634 in CG, 454 in IG). | Cluster randomized clinical trial. Clusterded by primary health care centres to 2 groups. Follow-up: 1 + 2 years (n = 872 in 12-month and 956 in 24-months). Goals Based on the Diabetes in Europe-Prevention using Lifestyle, Physical Activity and Nutritional (DE-PLAN). | IG: Phase 1 consisted of intensive intervention through 4 1.5-h monthly educational sessions in small groups (10–15 patients) to encourage the adoption of healthy habits; Maintenance phase of regular contact with participants (at least once every 6 weeks) mainly via telephone calls from nurses. Control centers provided usual care. | Incidence of diabetes was 12.1% in the CG and 8.4% in IG, with an absolute difference of 3.8% (95% CI: 0.18 -7.4%, p = 0.045) and a relative risk reduction of 32% (0.68; 95% CI: 0.47–0.99, p = 0.048). ++ |
Kerala Diabetes Prevention Program (K-DPP) India Sathish et al., 2013 [81] Mathews et al., 2018 [82] Aziz et al., 2018 [83] Thankappan et al., 2018 [84] | Age 30–60 years; Indian Diabetes Risk Score value of ≥60; absence of diabetes in OGTT. | 3689 individuals were contacted through home visits; 1529 had Risk Score value of ≥60; 1209 attended community-based clinics; n = 1007 were enrolled (500 in IG and 507 in CG). age: 46 y | RCT in community settings in 2 groups. Follow-up: 12 + 24 months (n = 964 at 24 months) Goals: Increasing physical activity; promoting healthy eating habits; maintaining appropriate body weight by balancing calorie intake and physical activity; tobacco cessation; reducing alcohol consumption; ensuring adequate sleep. | Adapted from the Finnish Good Ageing in Lahti Region (GOAL) program and the Australian Greater Green Triangle (GGT) Diabetes Prevention Project. IG got 15 group sessions over 12 months (1 session delivered by the research team, 2 sessions by local experts and 12 sessions by trained lay peer leaders), a handbook of peer support and its role in lifestyle modification and a workbook to guide self-monitoring of lifestyle behaviours, goal setting and goal review. Both groups got health education booklet. | At 24 months, diabetes developed in 17.1% in CG and 14.9% in IG (RR: 0.88, 95% CI 0.66–1.16, p = 0.36). IG had significantly greater reduction in Indian Diabetes Risk Score and alcohol use and a greater increase in fruit and vegetable intake and physical functioning score of the HRQoL scale. ++ |
Jew and Bedouin women with recent GDM in the Negev area. Israel Zilberman-Kravits et al., 2018 [85] | Jewish and Bedouin women with prior GDM prior GDM | 307 women identified; n = 180 (103 in IG, 77 in CG). sex: 100% women age: 35,6 y n = 176 at 12-month follow-up; n = 104 at 24-month follow-up. | RCT in2 groups. Follow-up: 1 and to 2 years after baseline (n = 176 at 12-months; n = 104 at 24-months) Culturally adapted dietary and exercise recommendations for increase PA and decrease unhealthy foods. | The IG participated in healthy lifestyle sessions led by a dietician and a sports instructor for 24 months after delivery. Participants had 3 individual 45-min counselling sessions and 4 90-min group meetings (10 women each). Participants were given both verbal and written information, had the opportunity to practice physical activities during the meetings and received healthy meals that included low-fat products, such as yogurt, vegetables, fruits and whole-grains. | The intervention significantly reduced insulin, glucose and HOMA-IR levels compared with control (p < 0.001). Also significant differences in lipidemic profile, blood pressure and physical activity level between groups. + |