Table 1.
Summary of large-scale randomized controlled trials incorporating meal replacements as part of a comprehensive lifestyle intervention in diabetes management.
| Study (reference) | Design | Subjects | Interventions | Results |
|---|---|---|---|---|
| Look AHEAD Study (8, 18, 19) | Multi-centre, randomized controlled trial | 5145 OW/OB patients with T2D | Intensive lifestyle intervention (ILI) involved a caloric target of 1200-1800 kcal/day, use of meal replacement (MR) products (weeks 3 to 19 only), and >175 minutes of moderate-intensity physical activity per week Diabetes support and education (DSE) involved group sessions focused on diet, exercise and social support |
20 outcomes (ILI vs. DSE):
Weight loss & 10 outcome: participants who achieved >10% weight loss had 21% lower risk of the 10 outcome (composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for angina) compared with participants who had stable weight or weight gain MR use: at year 1, participants in the highest quartile of MR use had greater odds of reaching the 7% and 10% weight loss goal than did participants in the lowest quartile of MR use |
| DiRECT (14) | Open-label, cluster randomized trial | 298 OW/OB patients with T2D from 49 primary care practices | Intervention involved total diet replacement using formula diet for 3–5 months, stepped food reintroduction for 2–8 weeks, and structured support for long-term weight loss maintenance Control group involved best practice care by guidelines |
Diabetes remission: 46% of participants in the intervention group achieved diabetes remission vs. 4% of participants in the control group MR use: total diet replacement using formula diet resulted in weight loss of 14.5 kg in participants that engaged with the intervention (completers) vs. 3 kg in non-completers |
| PREVIEW Study (16) | Randomized trial with 2x2 factorial design (two diets and two physical activity programs) | 2326 adults with pre-diabetes | Participants completed an 8-week weight loss phase which involved a low-energy diet consisting of meal replacement products Those who achieved weight loss of >8% continued on to the weight maintenance phase (148 weeks) consisting of a combination of one of two diets (high or moderate protein) with one of two physical activity (high or moderate intensity) programs |
1,857/2,326 (79.8%) participants achieved >8% weight loss during the 8-week weight loss phase No significant differences were observed in 3-year T2D incidence between diets, physical activity, or their combination Overall incidence of T2D was very low (3.1%), especially when compared to previous diabetes prevention studies (10.5%-15.8%) |
CKD, chronic kidney disease; NAFLD, non-alcoholic fatty liver disease; OW/OB, overweight or obese; T2D, type 2 diabetes.