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

Abstract

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%, along with other clinical benefits, after an 18-month intervention.

Trial registration number

NCT04192357.

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Fig. 1
Fig. 2: WLM3P group results vs. LCD group at 18 months.

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Data availability

The full data sets generated during and/or analyzed during the current study are not publicly available because the ethics committee only allowed the use of the data in the context of the present research project; however, anonymized partial data sets or summaries of the data are available from the corresponding author on reasonable request.

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Acknowledgements

The authors express their gratitude to all participants involved in this study.

Funding

This work was sponsored by Farmodiética 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 Fundação para a Ciência e a Technologia, I.P., within the scope of the project “RISE – LA/P/0053/2020”. 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.

Author information

Authors and Affiliations

Authors

Contributions

André Moreira-Rosário, Conceição Calhau, Diana Teixeira, Filipa Cortez, Marta P. Silvestre, and Vanessa Pereira conceived the study design. André Moreira-Rosário and Marta P. Silvestre are the methodology and clinical nutrition leaders, respectively; in turn, Conceição Calhau is the principal investigator of this clinical trial. Vanessa Pereira was responsible for the protocol and procedures writing under the supervision of André Moreira-Rosário and Marta P. Silvestre. Vanessa Pereira drafted the manuscript. Cláudia Camila Dias was responsible for the statistical analysis plan and did not have any interference in the study design and implementation. Inês Barreiros-Mota, Conceição Calhau, Diana Teixeira, Filipa Cortez, Cláudia Camila Dias, André Moreira-Rosário, and Marta P. Silvestre reviewed and edited the manuscript. All authors have read and agreed to the published version of the manuscript.

Corresponding authors

Correspondence to André Moreira-Rosário or Marta P. Silvestre.

Ethics declarations

Competing interests

Vanessa Pereira and Filipa Cortez work at Farmodiética S.A., one of the study sponsors. The sponsor provided support in the form of salaries for the author (Vanessa Pereira) and research materials but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the paper. The other researchers do not have any relationship with this sponsor.

Ethics approval and consent to participate

This trial was registered at clinical trials.gov under the identifier NCT04192357. The recruitment and data collection of this study have already been completed. The study was approved by the Ethics Committee of the NOVA Medical School (Lisbon, Portugal) (CEFCM Approval Number: 108/2018) and was registered at www.clinicaltrials.gov (NCT04192357) before participants’ recruitment. All participants provided written informed consent in accordance with the principles of the Declaration of Helsinki. Written informed consent has been obtained from the patients to publish this paper.

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Pereira, V., Barreiros-Mota, I., Cortez, F. et al. A randomized controlled trial of a weight loss maintenance program in adults with obesity: the WLM3P study. Eur J Clin Nutr (2024). https://doi.org/10.1038/s41430-024-01454-4

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