Table 1.
Description of study population and study design of the included trials grouped according to the type of intervention.
| Study population | Study design | Main trial info PMIDs | Included studies (PMDIs) | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Trial/Study name | Country | Total enrolled; inclusion criteria | Baseline enrollment years | Intervention design | Active intervention duration | Intervention(s) | Comparator/control intervention | ||
| Lifestyle interventions | |||||||||
| Chae et al.27 | South Korea | N = 7233; General population | 2007/11 | Non-randomized, parallel arm | 6 months | Physical activity program | Usual care | 2268854927 | 2268854927 |
| Da Qing IGT and Diabetes Study | China | N = 577; Prediabetes | 1986 | Cluster-randomized trial | 6 years |
(i) Diet: Low-calorie, low-fat (25–30% kcal) healthy pattern; (ii) Increase exercise; (iii) Diet + Exercise |
Provided with diabetes education materials at baseline | 90969775 | 2473167428, 3421246517, 1241377929 |
| Diabetes Community Lifestyle Improvement Program (D-CLIP) | India | N = 578; Prediabetes | 2009/12 | Randomized, parallel arm | 3 years | Lifestyle diabetes prevention program + Metformin | Lifestyle diabetes prevention program at baseline | 2750401418 | 2750401418 |
| Diabetes in Europe—Prevention using Lifestyle, Physical Activity and Nutritional - Catalonia (DE-PLAN-CAT)a | Spain | N = 544; Prediabetes | 2006 | Non-randomized, parallel arm | 4 years | Lifestyle weight loss and diabetes prevention program | Provided with diabetes education materials at baseline | 2232292130 | 2232292130 |
| Diabetes Prevention Program (DPP)a | US | N = 3234; Prediabetes | 1996/99 | Randomized, parallel arm | Mean 2.8 years | (i) Lifestyle weight loss and diabetes prevention program; (ii) Metformin | Usual care + placebo | 118325273 | 2602485131; 3344415832; 3331762933; 2845378034; 1964096035; 2386072236; 1685526437; 1901775138; 1806066039; 118325273; 2351295140; 1707720241; 1987898642; 3339454543; 2902120744; 2137817545; 2068268746; 1736374047; 2569749448; 2527738949 |
| EDIPS-Newcastle | UK | N = 102; Prediabetes | Randomized, parallel arm | 5 years | Lifestyle diabetes prevention program | Usual care | 1975842850 | 2345116651 | |
| Finnish Diabetes Prevention Study (DPS)a | Finland | N = 522; Prediabetes | 1993/98 | Randomized, parallel arm | Mean 3.2 years | Lifestyle and weight loss diabetes prevention program | Provided with diabetes education materials at baseline | 113339904 | 1675931352; 1727758553; 1687369954; 1824921955; 1965191956; 1763611457; 113339904; 2098041258; 1214517459; 1512720360; 1825290061; 1561602462; 1530929263; 1598323064; 1809102365, 1512651466 1743708067 |
| Indian Diabetes Prevention Program 2013 (IDPP-2013) | India | N = 537; Men with prediabetes | 2009 | Randomized, parallel arm | 24 months | SMS-delivered lifestyle diabetes prevention education | Provided with diabetes education materials at baseline | 2462236768 | 2677387169; 163919036 |
| Indian Diabetes Prevention Programme (IDPP-1) | India | N = 531; Prediabetes | 2001/02 | Randomized, parallel arm | 3 years |
(i) Lifestyle diabetes prevention program; (ii) Metformin; (iii) Lifestyle + Metformin |
Usual care | 163919036 | 163919036, 2051966370, 2677387169 |
| Indian Diabetes Prevention Programme (IDPP-2) | India | N = 407; Prediabetes | 2003/05 | Randomized, parallel arm | 3 years | Lifestyle diabetes prevention program + Pioglitazone | Lifestyle diabetes prevention program + Placebo | 1927760271 | 2051966370 |
| Japan Diabetes Prevention Program (Japan DPP)a | Japan | N = 304; Prediabetes | 1999/02 | Randomized, parallel arm | 3 years | Lifestyle weight loss and diabetes prevention program | Provided with diabetes education materials at baseline | 2545285472 | 2545285472; 2123582520 |
| Kerala Diabetes Prevention Program (K-DPP) | India | N = 1007; Prediabetes, rural | 2013 | Cluster-randomized trial | 12 months | Peer-led lifestyle diabetes prevention program | Provided with diabetes education materials at baseline | 2418031673 | 2987423674 |
| Kosaka et al.a75 | Japan | N = 458; Men with prediabetes | 1990/92 | Randomized, parallel arm | 4 years | Lifestyle weight loss and diabetes prevention program | Lifestyle weight loss and diabetes prevention information only | 1564957575 | 1564957575 |
| Let’s Prevent Diabetes | UK | N = 880; Prediabetes | 2009/11 | Cluster-randomized trial | 36 months | Lifestyle diabetes prevention program | Provided with diabetes education materials at baseline | 2260716076 | 2674034677 |
| Multiple Risk Factor Intervention Trial (MRFIT) | US | N = 12,866; Men with high cardiovascular risk | 1973/76 | Randomized, parallel arm | 6 years | Lifestyle modifications for heart disease prevention | Usual care | 1573845078 | 1573845078 |
| Nanditha et al. 79 | India, UK | N = 2062; Prediabetes | 2012/17 | Randomized, parallel arm | 24 months | SMS-delivered lifestyle diabetes prevention education | Provided with diabetes education materials at baseline | 3191953979 | 3191953979 |
| National Program for the Prevention of Type 2 Diabetes (FIN-D2D)a | Finland | N = 2798; Prediabetes | 2004/07 | Population-wide intervention | Mean 14 months | Lifestyle weight loss and diabetes prevention program | – | 2066402080 | 2298378581; 3377151582; 2178115383; 2066402080; 2162267784 |
| Niyantrita Madhumeha Bharata Abhiyaan (NMB-Trial) | India | N = 4450; Prediabetes | 2017 | Cluster-randomized trial | 3 months | Yoga-based lifestyle diabetes prevention program | Presentation on lifestyle for diabetes prevention at baseline | 3417780585 | 3417780585 |
| Norfolk Diabetes Prevention Study (NDPS) | UK | N = 1028; Prediabetes | 2011/18 | Randomized, parallel arm | 12–46 months | (i) Lifestyle diabetes prevention program; (ii) Lifestyle diabetes prevention program with peer support | Provided with diabetes education materials at baseline | 3313611986 | 3313611986 |
| Prevention of Diabetes in Euskadi (PreDE)a | Spain | N = 1088; Prediabetes | 2011/13 | Cluster-randomized trial | 24 months | Lifestyle weight loss and diabetes prevention program | Usual care | 2947688887 | 2947688887 |
| Tehran Lipid and Glucose Study (TLGS) | Iran | N = 10,368; General population | 1999/01 | Non-randomized, cluster | Mean 3.6 years | Lifestyle program for chronic disease prevention | Usual care | 2049423988 | 2502936889; 2049423988 |
| Thai Diabetes Prevention Program (Thai DPP) | Thailand | N = 1903; Prediabetes | 2013 | Cluster-randomized trial | 24 months | Lifestyle diabetes prevention program | Provided with diabetes education materials at baseline | 3107951719 | 3107951719 |
| Västerbotten Intervention Programme (VIP) | Sweden | N = 113, 203; General population | 1987-present | Population-wide intervention | Ongoing | Lifestyle CVD and diabetes prevention program | – | 2033947990 | 2553267891 |
| Zensharen Study for Prevention of Lifestyle Diseasesa | Japan | N = 641; Prediabetes | 2004/06 | Randomized, parallel arm | 36 months | Lifestyle weight loss program + Frequent engagement | Lifestyle weight loss program + Minimal engagement | 2182494892 | 2182494892 |
| Dietary pattern interventions | |||||||||
| CORonary Diet Intervention with Olive oil and cardiovascular PREVention study (CORDIOPREV) | Spain | N = 1002; Prevalent heart disease | 2009/12 | Randomized, parallel arm | Median 7 years | Mediterranean dietary pattern | AHA low-fat pattern (<30% kcal) | 2729784893 | 3272350894 |
| Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts (PREDIMED) | Spain | N = 7447; High cardiovascular risk | 2003/09 | Randomized, parallel arm | 4.8 years |
(i) Mediterranean pattern + extra-virgin olive oil; (ii) Mediterranean pattern + mixed nuts |
Low-fat pattern | 2989786695 | 2966301196, 2673999697; 2303496298; 3137717999; 24573661100; 20929998101 |
| Shahbazi et al. 102 | Iran | N = 336; Prediabetes | 2012 | Randomized, parallel arm | 2 years |
(i) High-fat diet from olive oil (45% kcal); (ii) Normal fat diet (30% kcal) |
Standard low-fat diet (<30% kcal) | DOI 10.1007/s13410-017-0548-3 | DOI 10.1007/s13410-017-0548-3102 |
| Women’s Health Initiative Dietary Modification Trial (WHI-DM) | US | N = 48,835; Healthy postmenopausal women | 1993/98 | Randomized, parallel arm | Mean 8.1 years | Low-fat (20% kcal) healthy pattern | Provided with healthy diet materials at baseline | 18663162103 | 29282203104 |
| Dietary supplement interventions | |||||||||
| Alpha-Tocopherol, Beta-Carotene Lung Cancer Prevention Study (ATBC) | Finland | N = 29,133; Men, smokers | 1985/88 | Randomized, parallel arm | Median 6.1 years | 2 × 2 factorial: (i) alpha-tocopherol (50 mg/day), (ii) beta-carotene (20 mg/day) | Placebo | 8205268105 | 17994292106 |
| Vitamin D and Type 2 Diabetes Trial (D2d) | US | N = 2423; Prediabetes | 2013/17 | Randomized, parallel arm | Median 2.5 years | Vitamin D supplementation (4000 IU/day) | Placebo | 31173679107 | 31173679107 |
| Women’s Antioxidant and Folic Acid Cardiovascular Study (WAFACS) | US | N = 5442; Women with cardiovascular disease | 1998 | Randomized, parallel arm | Median 7.3 years | Folic acid (2.5 mg/day), vitamin B6 (50 mg/day), and vitamin B12 (1 mg/day) combined supplementation | Placebo | 19491213108 | 19491213108 |
| Women’s Antioxidant Cardiovascular Study (WACS) | US | N = 8171; Women with cardiovascular disease | 1995/96 | Randomized, parallel arm | Median 9.2 years | 2 × 2 × 2 factorial: (i) vitamin C (500 mg/day), (ii) vitamin E (600 IU/day), (iii) beta-carotene (50 mg/eod) supplementation | Placebo | 19491386109 | 19491386109 |
| Women’s Health Study (WHS) | US | N = 39,876; Healthy women | 1992/95 | Randomized, parallel arm | 10.1 years | 2 × 2 Factorial, every other day: Aspirin (100 mg); (ii) Vitamin E supplementation (600 IU) | Placebo | 15998891110 | 17003353111 |
aTrials which aimed at weight loss and prevention of T2D.