A Randomised Controlled Trial of a Weight Loss Maintenance Program for Adults With Obesity: The WLM3P Study
WLM3P
1 other identifier
interventional
112
1 country
1
Brief Summary
The aim of this study is to evaluate the effectiveness of a Weight Loss Maintenance 3 Phases Program (WLM3P) in maintaining long-term weight loss (at least 5% of initial body weight loss at 18 months), compared to a standard low carbohydrate diet (LCD) in adults with obesity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Mar 2021
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2019
CompletedFirst Posted
Study publicly available on registry
December 10, 2019
CompletedStudy Start
First participant enrolled
March 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedFebruary 8, 2023
February 1, 2023
1.8 years
December 6, 2019
February 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in weight
Difference between the intervention and control group in the change of weight from baseline to the end of follow-up.
18 months
Secondary Outcomes (21)
Change in total fat mass
18 months
Change in waist circumference
18 months
Change in body mass index
18 months
Change in systolic and diastolic blood pressure
18 months
Change in intestinal microbiota
18 months
- +16 more secondary outcomes
Study Arms (2)
WLM3P
EXPERIMENTALParticipants will receive the M3F program. The M3F program is divided into three phases, being the first two of weight loss and the third phase of weight maintenance.
Low-carb diet
ACTIVE COMPARATORParticipants will receive the low-carb diet program. The low-carb diet program is divided into two phases, being the first of weight loss which follows a low carb diet, and a second phase of weight maintenance.
Interventions
18 months behavioral weight loss program divided into three phases (first and second phase of weight loss, during 1 month and 5 months, respectively; and a third phase of weight maintenance, during 12 months).
18 months behavioral weight loss program divided in two phases (first of weight loss during 6 months and a second phase of weight maintenance during 12 months).
Eligibility Criteria
You may qualify if:
- Men and women aged 18 to 65 years
- BMI ≥ 30 kg/m2 and ≤ 39.9 kg/m2
- Interested in being enrolled in a weight loss program
- Available to comply with study protocol and sign informed consent
You may not qualify if:
- Pregnant, breastfeeding or planning to become pregnant within the study period.
- Subjects with chronic inflammatory bowel disease (clinical history of Crohn's disease, ulcerative colitis, irritable colon and diverticulitis)
- Subjects with hormonal or thyroid pathology (hyper and hypothyroidism where TSH is not within normal range)
- Subjects with renal impairment
- Subjects with chronic liver disease other than non-alcoholic hepatic steatosis
- Subjects with autoimmune diseases and/or chronic use of corticosteroids.
- Use of weight loss medications/other nutritional supplements
- Subjects with psychiatric or neurological illness
- Subjects sensitive to any component of supplements
- Subjects with surgery or hospitalization in the last 30 days
- Subjects prescribed with 5 or more drugs
- Previous attempt to lose weight in the last month and/or weight loss of more than 10kg in the 3 months prior to the start of the study
- Subjects with excessive alcohol consumption (self-reported: drinking more than 3 glasses of wine/day - or equivalent)
- Subjects with history of drug, alcohol or other substances abuse.
- Eating behavior disorders
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NOVA Medical School, NOVA University of Lisbon
Lisbon, 1169-056, Portugal
Related Publications (2)
Pereira V, Cuevas-Sierra A, de la O V, Salvado R, Barreiros-Mota I, Castela I, Camelo A, Brandao I, Santo CE, Faria A, Calhau C, Silvestre MP, Moreira-Rosario A. Gut Microbiota Shifts After a Weight Loss Program in Adults with Obesity: The WLM3P Study. Nutrients. 2025 Jul 18;17(14):2360. doi: 10.3390/nu17142360.
PMID: 40732984DERIVEDPereira V, Barreiros-Mota I, Cortez F, Castela I, Teixeira D, Calhau C, Camila Dias C, Moreira-Rosario A, Silvestre MP. A randomized controlled trial of a weight loss maintenance program in adults with obesity: the WLM3P study. Eur J Clin Nutr. 2024 Aug;78(8):694-702. doi: 10.1038/s41430-024-01454-4. Epub 2024 Jun 6.
PMID: 38844671DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Conceição Calhau, PhD
CINTESIS, NOVA Medical School
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2019
First Posted
December 10, 2019
Study Start
March 25, 2021
Primary Completion
January 20, 2023
Study Completion
June 1, 2023
Last Updated
February 8, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share