A Randomised Controlled Trial of a Weight Loss Maintenance Program for Adults With Obesity: The WLM3P Study

Study Overview
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Brief Summary
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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.

Official Title
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A Randomised Controlled Trial of a Weight Loss Maintenance Program for Adults With Obesity: The WLM3P Study

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: WLM3P
* Behavioral: Low-carb diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 Pacemaker carrier Urinary incontinence Vegetarians or vegans Subjects underwent bariatric surgery Type 1 or type 2 diabetes mellitus Altered blood clotting Severe heart failure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WLM3P<br>Participants 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. | Behavioral: WLM3P<br>* 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).<br>|
| Active Comparator: Low-carb diet<br>Participants 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. | Behavioral: Low-carb diet<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total fat mass | Difference between the intervention and control group in the change of total fat mass, measured by bioimpedance analysis from baseline to the end of follow-up. | 18 months | 
| Change in waist circumference | Difference between the intervention and control group in the change of waist circumference from baseline to the end of follow-up. | 18 months | 
| Change in body mass index | Change in body mass index (calculated as change in kg/m2, weight in kilograms, height in meters) from baseline to the end of follow-up. | 18 months | 
| Change in systolic and diastolic blood pressure | Difference between the intervention and control group in the change in systolic and diastolic blood pressure from baseline to the end of follow-up. | 18 months | 
| Change in intestinal microbiota | Difference between the intervention and control group in the change of intestinal microbiota from baseline to the end of follow-up. Bacterial DNA will be extracted from fecal samples. 16SRNA gene will be sequenced by next-generation sequencing (NGS). All the identified bacterial phyla, genus and species will be expressed in percentage. | 18 months | 
| Change in fasting plasma glucose concentrations | Difference between the intervention and control group in the change of serum glucose concentrations from baseline to the end of follow-up. | 18 months | 
| Change in fasting plasma insulin concentrations | Difference between the intervention and control group in the change of serum insulin concentrations from baseline to the end of follow-up. | 18 months | 
| Change in fasting plasma triglycerides concentrations | Difference between the intervention and control group in the change of serum triglycerides concentrations from baseline to the end of follow-up. | 18 months | 
| Change in fasting plasma low density lipoprotein (LDL) concentrations | Difference between the intervention and control group in the change of serum low density lipoprotein (LDL) concentrations from baseline to the end of follow-up. | 18 months | 
| Change in fasting plasma high density lipoprotein (HDL) concentrations | Difference between the intervention and control group in the change of serum high density lipoprotein (HDL) concentrations from baseline to the end of follow-up. | 18 months | 
| Change in fasting plasma glycated hemoglobin A1c (HbA1c) concentrations | Difference between the intervention and control group in the change of serum glycated hemoglobin A1c (HbA1c) concentrations from baseline to the end of follow-up. | 18 months | 
| Change in alanine aminotransferase (ALT) concentrations | Difference between the intervention and control group in the change of alanine aminotransferase (ALT) concentrations from baseline to the end of follow-up. | 18 months | 
| Change in aspartate aminotransferase (AST) concentrations | Difference between the intervention and control group in the change of aspartate aminotransferase (AST) concentrations from baseline to the end of follow-up. | 18 months | 
| Change in gamma-glutamyl transpeptidase (GGT) concentrations | Difference between the intervention and control group in the change of gamma-glutamyl transpeptidase (GGT) concentrations from baseline to the end of follow-up. | 18 months | 
| Change in HOMA-IR | Difference between the intervention and control group in HOMA-IR (homeostasis model assessment of insulin resistance) from baseline to the end of follow-up, calculated using the formula: fasting plasma glucose (mmol/L) x Fasting insulin (mIU/L)/22.5. | 18 months | 
| Change in creatinine concentrations | Difference between the intervention and control group in the change of creatinine concentrations from baseline to the end of follow-up. | 18 months | 
| Change in vitamin D concentrations | Difference between the intervention and control group in the change of vitamin D concentrations from baseline to the end of follow-up. | 18 months | 
| Change in high-sensitivity C-reactive protein (hs-CRP) concentrations | Difference between the intervention and control group in the change of high-sensitivity C-reactive protein (hs-CRP) concentrations from baseline to the end of follow-up. | 18 months | 
| Change in sodium concentrations | Difference between the intervention and control group in the change of sodium concentrations from baseline to the end of follow-up. | 18 months | 
| Change in potassium concentrations | Difference between the intervention and control group in the change of potassium concentrations from baseline to the end of follow-up. | 18 months | 
| Change in magnesium concentrations | Difference between the intervention and control group in the change of magnesium concentrations from baseline to the end of follow-up. | 18 months |