A Randomized Controlled Trial of a Weight Loss Maintenance Program in Adults with Obesity: The WLM3P Study

Abstract

Abstract Background/Objectives: Obesity, a chronic disease, requires effective strategies for weight loss (WL) and sustained maintenance. This study aimed to evaluate the effectiveness of the Weight Loss Maintenance 3 Phases Program (WLM3P) in achieving a clinically significant long-term WL (≥5% initial WL at 18 months) in adults with obesity compared to a standard low-carbohydrate diet (LCD). Subjects/Methods: In this two-phase trial, 112 participants targeting initial WL (0-6 months) and subsequent maintenance (7-18 months) were randomly assigned to either WLM3P or LCD groups. Results: Of 112 randomized participants, 69% (n=77) completed the study. At 18 months, WL in the WLM3P group (n=40) was 15.5±8.3% compared to 9.6±8.5% in the LCD group (n=37) (p<0.001). The odds ratio of achieving WL≥10% and ≥15% were significantly higher in the WLM3P group at 18 months. Complete-case analysis revealed significantly greater improvements in BMI, body fat mass, visceral fat area, waist circumference, waist-to-hip ratio, HDL, and triglyceride/HDL ratio in WLM3P than in LCD. No serious adverse events were reported. Conclusion: Both programs were effective in promoting clinically relevant WL and its maintenance. However, the WLM3P program was more successful in helping participants achieve greater WL targets of ≥10% and ≥15%, along with other clinical benefits, after an 18-month intervention. Trial registration number: NCT04192357.