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

European Journal of Clinical Nutrition volume 78, pages 694–702 (2024)Cite this article

Subjects

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.

References

  1. Frühbeck G, Busetto L, Dicker D, Yumuk V, Goossens GH, Hebebrand J, et al. The ABCD of obesity: an EASO position statement on a diagnostic term with clinical and scientific implications. Obes Facts. 2019;12:131–6. https://doi.org/10.1159/000497124.

    Article  PubMed  PubMed Central  Google Scholar 

  2. Organisation for Economic Cooperation and Development. Obesity among adults. https://www.oecd-ilibrary.org/sites/8cdeadfa-en/index.html?itemId=/content/component/8cdeadfa-en. Accessed 20 Apr 2023.

  3. Instituto Nacional De Estatística. Inquérito Nacional de Saúde 2019. https://www.ine.pt/xportal/xmain?xpid=INE&xpgid=ine_destaques&DESTAQUESdest_boui=414434213&DESTAQUESmodo=2&xlang=pt.

  4. Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, et al. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Obesity Society. Circulation. 2014;129. https://doi.org/10.1161/01.cir.0000437739.71477.ee.

  5. Durrer Schutz D, Busetto L, Dicker D, Farpour-Lambert N, Pryke R, Toplak H, et al. European practical and patient-centred guidelines for adult obesity management in primary care. Obes Facts. 2019;12:40–66. https://doi.org/10.1159/000496183.

    Article  PubMed  PubMed Central  Google Scholar 

  6. Lv N, Mj Azar K, Rosas LG, Wulfovich S, Xiao L, Ma J, et al. Behavioral lifestyle interventions for moderate and severe obesity: a systematic review. Prev Med. 2017;100:180–93. https://doi.org/10.1016/j.ypmed.2017.04.022.

    Article  PubMed  PubMed Central  Google Scholar 

  7. Soliman, GA. Intermittent fasting and time-restricted eating role in dietary interventions and precision nutrition. Front Public Health. 2022;10. https://doi.org/10.3389/FPUBH.2022.1017254.

  8. Sun JC, Tan ZT, He CJ, Hu HL, Zhai CL, Qian G. Time-restricted eating with calorie restriction on weight loss and cardiometabolic risk: a systematic review and meta-analysis. Eur J Clin Nutr. 2023;77:1014–25. https://doi.org/10.1038/S41430-023-01311-W.

    Article  PubMed  PubMed Central  Google Scholar 

  9. Mah E, Chen O, Liska DJ, Blumberg JB. Dietary supplements for weight management: a narrative review of safety and metabolic health benefits. Nutrients. 2022;14. https://doi.org/10.3390/NU14091787.

  10. Konstantinidi M, Koutelidakis AE. Functional foods and bioactive compounds: a review of its possible role on weight management and obesity’s metabolic consequences. Medicines. 2019;6:94. https://doi.org/10.3390/medicines6030094.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  11. Haghighat N, Ashtary-Larky D, Bagheri R, Wong A, Cheraghloo N, Moradpour G, et al. Effects of 6 months of soy-enriched high protein compared to eucaloric low protein snack replacement on appetite, dietary intake, and body composition in normal-weight obese women: a randomized controlled trial. Nutrients. 2021;13. https://doi.org/10.3390/NU13072266.

  12. Kupila SKE, Joki A, Suojanen LU, Pietiläinen KH. The effectiveness of eHealth interventions for weight loss and weight loss maintenance in adults with overweight or obesity: a systematic review of systematic reviews. Curr Obes Rep. 2023;12:371–94. https://doi.org/10.1007/s13679-023-00515-2.

    Article  PubMed  PubMed Central  Google Scholar 

  13. Irvin L, Madden LA, Marshall P, Vince RV. Digital health solutions for weight loss and obesity: a narrative review. Nutrients. 2023;15. https://doi.org/10.3390/NU15081858.

  14. Dening J, Islam SMS. Defining a low carbohydrate diet: proposal for a standardized consensus of carbohydrate intake (Carb-Cal Model). Diabetes Res Clin Pract. 2020;166. https://doi.org/10.1016/J.DIABRES.2020.108284.

  15. Clifton PM, Condo D, Keogh JB. Long term weight maintenance after advice to consume low carbohydrate, higher protein diets-a systematic review and meta analysis. Nutr Metab Cardiovasc Dis. 2014;24:224–35. https://doi.org/10.1016/J.NUMECD.2013.11.006.

    Article  CAS  PubMed  Google Scholar 

  16. Lei L, Huang J, Zhang L, Hong Y, Hui S, Yang J. Effects of low-carbohydrate diets versus low-fat diets on metabolic risk factors in overweight and obese adults: a meta-analysis of randomized controlled trials. Front Nutr. 2022;9. https://doi.org/10.3389/FNUT.2022.935234/FULL.

  17. Magkos F. Protein-rich diets for weight loss maintenance. Curr Obes Rep. 2020;9:213–8. https://doi.org/10.1007/S13679-020-00391-0.

    Article  PubMed  Google Scholar 

  18. Moon J, Koh G. Clinical evidence and mechanisms of high-protein diet-induced weight loss. J Obes Metab Syndr. 2020;29:166. https://doi.org/10.7570/JOMES20028.

    Article  PubMed  PubMed Central  Google Scholar 

  19. Direção-Geral da Saúde. Avaliação Antropométrica No Adulto. Orientação no 017/2013 de 05/12/2013. 2013:1–9.

  20. Direção-Geral de Saúde. Norma nº 026/2011 – Abordagem Terapêutica da Hipertensão Arterial (atualizada 19/03/2013). Lisboa: Direção-Geral da Saúde; 2013.

  21. Martins I, Porto A. e Oliveira L. Tabela de composição de alimentos. INSA. 2006

  22. Craig CL, Marshall AL, Sjöström M, Bauman AE, Booth ML, Ainsworth BE, et al. International Physical Activity Questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003;35:1381–95. https://doi.org/10.1249/01.MSS.0000078924.61453.FB.

    Article  PubMed  Google Scholar 

  23. Garaulet M, Ortega FB, Ruiz JR, Rey-López JP, Béghin L, Manios Y, et al. Short sleep duration is associated with increased obesity markers in European adolescents: effect of physical activity and dietary habits. The HELENA Study. Int J Obes. 2011;35:1308–17. https://doi.org/10.1038/IJO.2011.149.

    Article  CAS  Google Scholar 

  24. Vijayananthan A, Nawawi O. The importance of good clinical practice guidelines and its role in clinical trials. Biomed Imaging Interv J. 2008;4:1–4. https://doi.org/10.2349/biij.4.1.e5.

    Article  Google Scholar 

  25. Acharya SD, Elci OU, Sereika SM, Music E, Styn MA, Turk MW, et al. Adherence to a behavioral weight loss treatment program enhances weight loss and improvements in biomarkers. Patient Prefer Adherence. 2009;3:151. https://doi.org/10.2147/PPA.S5802.

    Article  PubMed  PubMed Central  Google Scholar 

  26. Nelson M, Atkinson M, Darbyshire S. Food Photography II: portion size and the nutrient content of meals. Br J Nutr. 1996;76:31–49.

    Article  CAS  PubMed  Google Scholar 

  27. Horn DB, Almandoz JP, Look M. What is clinically relevant weight loss for your patients and how can it be achieved? A narrative review. Postgrad Med. 2022;134:359–75. https://doi.org/10.1080/00325481.2022.2051366.

    Article  PubMed  Google Scholar 

  28. Li G, Rios RS, Wang XX, Yu Y, Zheng KI, Huang OY, et al. Sex influences the association between appendicular skeletal muscle mass to visceral fat area ratio and non-alcoholic steatohepatitis in patients with biopsy-proven non-alcoholic fatty liver disease. Br J Nutr. 2022;127:1613–20. https://doi.org/10.1017/S0007114521002415.

    Article  CAS  PubMed  Google Scholar 

  29. Liu D, Zhong J, Wen W, Ruan Y, Zhang Z, Sun J, et al. Relationship between skeletal muscle mass to visceral fat area ratio and cardiovascular risk in type 2 diabetes. Diabetes Metab Syndr Obes. 2021;14:3733–42. https://doi.org/10.2147/DMSO.S326195.

    Article  PubMed  PubMed Central  Google Scholar 

  30. Liang S, Mijatovic J, Li A, Koemel N, Nasir R, Toniutti C, et al. Dietary patterns and non-communicable disease biomarkers: a network meta-analysis and nutritional geometry approach. Nutrients. 2023;15. https://doi.org/10.3390/NU15010076/S1.

  31. Raynor HA, Looney SM, Steeves EA, Spence M, Gorin AA. The effects of an energy density prescription on diet quality and weight loss: a pilot randomized controlled trial. J Acad Nutr Diet. 2012;112:1397–402. https://doi.org/10.1016/J.JAND.2012.02.020.

    Article  PubMed  Google Scholar 

  32. Lemstra M, Bird Y, Nwankwo C, Rogers M, Moraros J. Weight loss intervention adherence and factors promoting adherence: a meta-analysis. Patient Prefer Adherence. 2016;10:1547–59. https://doi.org/10.2147/PPA.S103649.

    Article  PubMed  PubMed Central  Google Scholar 

  33. Hirshkowitz M, Whiton K, Albert SM, Alessi C, Bruni O, DonCarlos L, et al. National sleep foundation’s updated sleep duration recommendations: final report. Sleep Health. 2015;1:233–43. https://doi.org/10.1016/J.SLEH.2015.10.004.

    Article  PubMed  Google Scholar 

  34. Gudzune KA, Doshi RS, Mehta AK, Chaudhry ZW, Jacobs DK, Vakil RM, et al. Efficacy of commercial weight-loss programs: an updated systematic review. Ann Intern Med. 2015;162:501–12. https://doi.org/10.7326/M14-2238.

    Article  PubMed  PubMed Central  Google Scholar 

  35. Carneiro DM, Freire RC, Honório TCDD, Zoghaib I, Cardoso FFDSES, Tresvenzol LMF, et al. Randomized, double-blind clinical trial to assess the acute diuretic effect of Equisetum arvense (field horsetail) in healthy volunteers. Evid Based Complement Alternat Med. 2014;2014:760683 https://doi.org/10.1155/2014/760683.

    Article  PubMed  PubMed Central  Google Scholar 

  36. Elobeid MA, Padilla MA, McVie T, Thomas O, Brock DW, Musser B, et al. Missing data in randomized clinical trials for weight loss: scope of the problem, state of the field, and performance of statistical methods. PLoS ONE. 2009;4:e6624. https://doi.org/10.1371/JOURNAL.PONE.0006624.

    Article  PubMed  PubMed Central  Google Scholar 

  37. Lopes C, Torres D, Oliveira A, Severo M, Alarcão V, Guiomar S, et al. Inquérito Alimentar Nacional e de Atividade Física, IAN-AF 2015-2016: Relatório de resultados. 2016 p. 1–291.

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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.

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Author notes

  1. These authors contributed equally: André Moreira-Rosário, Marta P. Silvestre.

Authors and Affiliations

  1. NOVA Medical School, Faculty of Medical Sciences, NMS, FMC, Nova University of Lisbon, Lisbon, Portugal

    Vanessa Pereira, Inês Barreiros-Mota, Inês Castela, Diana Teixeira, Conceição Calhau, André Moreira-Rosário & Marta P. Silvestre

  2. Nutrition Department Farmodiética, Farmodiética, 2785-723, Lisbon, Portugal

    Vanessa Pereira & Filipa Cortez

  3. CHRC, NOVA Medical School, Faculty of Medical Sciences, NMS, FMC, Nova University of Lisbon, Lisbon, Portugal

    Inês Barreiros-Mota, Inês Castela, Diana Teixeira & Conceição Calhau

  4. Faculty of Nutrition and Food Sciences, University of Porto, Porto, Portugal

    Filipa Cortez

  5. CINTESIS@RISE, NOVA Medical School, Faculty of Medical Sciences, NMS, FMC, Nova University of Lisbon, Lisbon, Portugal

    Diana Teixeira, André Moreira-Rosário & Marta P. Silvestre

  6. Knowledge Management Unit, Faculty of Medicine of the University of Porto (FMUP), Porto, Portugal

    Cláudia Camila Dias

  7. CINTESIS@RISE, Department of Community Medicine, Information and Health Decision Sciences (MEDCIDS), Faculty of Medicine of the University of Porto, Porto, Portugal

    Cláudia Camila Dias

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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.

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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 78, 694–702 (2024). https://doi.org/10.1038/s41430-024-01454-4

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