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

Not Applicable

Active, not recruiting

• Conditions: Obesity
• Interventions: Behavioral: WLM3P; Behavioral: Low-carb diet

• Registration Number: NCT04192357
• Lead Sponsor: Universidade do Porto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-06
• Study First Submitted QC: 2019-12-06
• Study First Posted: 2019-12-10
• Study Start: 2021-03-25
• Primary Completion: 2023-01-20
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-03
• Last Update Posted: 2023-02-08
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WLM3P	WLM3P	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.
Low-carb diet	Low-carb diet	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.

Primary Outcome Measures

Name	Time	Method
Change in weight	18 months	Difference between the intervention and control group in the change of weight from baseline to the end of follow-up.

Secondary Outcome Measures

Name	Time	Method
Change in total fat mass	18 months	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.
Change in fasting plasma high density lipoprotein (HDL) concentrations	18 months	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.
Change in fasting plasma glycated hemoglobin A1c (HbA1c) concentrations	18 months	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.
Change in alanine aminotransferase (ALT) concentrations	18 months	Difference between the intervention and control group in the change of alanine aminotransferase (ALT) concentrations from baseline to the end of follow-up.
Change in aspartate aminotransferase (AST) concentrations	18 months	Difference between the intervention and control group in the change of aspartate aminotransferase (AST) concentrations from baseline to the end of follow-up.
Change in gamma-glutamyl transpeptidase (GGT) concentrations	18 months	Difference between the intervention and control group in the change of gamma-glutamyl transpeptidase (GGT) concentrations from baseline to the end of follow-up.
Change in HOMA-IR	18 months	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.
Change in creatinine concentrations	18 months	Difference between the intervention and control group in the change of creatinine concentrations from baseline to the end of follow-up.
Change in vitamin D concentrations	18 months	Difference between the intervention and control group in the change of vitamin D concentrations from baseline to the end of follow-up.
Change in high-sensitivity C-reactive protein (hs-CRP) concentrations	18 months	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.
Change in sodium concentrations	18 months	Difference between the intervention and control group in the change of sodium concentrations from baseline to the end of follow-up.
Change in potassium concentrations	18 months	Difference between the intervention and control group in the change of potassium concentrations from baseline to the end of follow-up.
Change in magnesium concentrations	18 months	Difference between the intervention and control group in the change of magnesium concentrations from baseline to the end of follow-up.
Change in waist circumference	18 months	Difference between the intervention and control group in the change of waist circumference from baseline to the end of follow-up.
Change in body mass index	18 months	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.
Change in systolic and diastolic blood pressure	18 months	Difference between the intervention and control group in the change in systolic and diastolic blood pressure from baseline to the end of follow-up.
Change in intestinal microbiota	18 months	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.
Change in fasting plasma glucose concentrations	18 months	Difference between the intervention and control group in the change of serum glucose concentrations from baseline to the end of follow-up.
Change in fasting plasma insulin concentrations	18 months	Difference between the intervention and control group in the change of serum insulin concentrations from baseline to the end of follow-up.
Change in fasting plasma triglycerides concentrations	18 months	Difference between the intervention and control group in the change of serum triglycerides concentrations from baseline to the end of follow-up.
Change in fasting plasma low density lipoprotein (LDL) concentrations	18 months	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.

Trial Locations

Locations (1)

NOVA Medical School, NOVA University of Lisbon; 🇵🇹 Lisboa, Portugal