A randomized controlled trial of a weight loss maintenance program in adults with obesity ; the WLM3P study

Funding Information: This work was sponsored by Farmodietica S.A. The study was also promoted by the CINTESIS@RISE, NOVA Medical School, NOVA University of Lisbon and financed by national funds through FCT Fundacao para a Ciencia e a Technologia, I.P., within the scope of the project \u201CRISE \u2013 LA/P/0053/2020\u201D. The sponsor and funder had no role in the study design and had no role during its execution, analysis, interpretation of the data, or decision to submit the results. Publisher Copyright: © The Author(s), under exclusive licence to Springer Nature Limited 2024. ; Background/Objectives: The escalating obesity epidemic necessitates effective, sustainable weight loss (WL) and maintenance strategies. This study aimed to evaluate the effectiveness of the Weight Loss Maintenance 3 Phases Program (WLM3P) in achieving a clinically significant long-term weight loss (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. Outcomes assessed included change in body weight (kg, %), improvements in body composition, and metabolic profile. 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. 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 effectively promoted clinically relevant WL and its maintenance. However, the WLM3P program was more successful in helping participants achieve greater WL targets of ≥10% and ≥15%, ...