A DiRECT approach to weight loss in a culturally diverse, low-income population: Pilot randomised controlled trial and meta-analysis of similar interventions.

Objective: To consider an intensive lifestyle intervention for weight loss in type 2 diabetes or prediabetes when delivered within a primary care service catering to indigenous (Māori), Pacific, refugee, and low-income clientele.

Methods: Adults with obesity, type 2 diabetes or prediabetes, and a desire to lose weight were randomised to dietitian-supported usual care or the Diabetes Remission Clinical Trial (DiRECT)-type intervention (3 months of total diet replacement followed by 9 months of food reintroduction and supported weight loss maintenance). Both interventions included equal dietetic support delivered within primary care. Primary outcome was weight loss at 3 and 12 months. We performed random-effects meta-analysis of body weight of existing DiRECT-type interventions.

Results: Forty participants were randomised to the dietitian-led DiRECT-type intervention or dietitian-supported usual care. At 3 months, weight loss among DiRECT-type intervention participants was -6.1 kg (95% CI -10.2, -2.0) greater than with dietetic support. At 12 months, this difference decreased to -3.8 kg (-7.6, -0.1) due to gradual weight loss with dietitian-supported usual care, not weight regain in DiRECT. Meta-analyses indicated -8.5 kg (-11.1, -5.9) and -6.0 kg (-8.4, -3.5) greater weight loss for DiRECT-type interventions than usual diabetes care (with or without dietary advice) at 3 and 12 months.

Conclusions: In this pilot effectiveness trial, the DiRECT-type intervention generated clinically relevant and greater weight loss than dietitian-supported usual care at 3 and 12 months. These results align with the effect sizes generated by meta-analyses of existing DiRECT-type interventions, demonstrating the potential use of DiRECT-type approaches across a much broader spectrum of the population than previously considered including those with both type 2 and prediabetes. ACTRN12622000151730.