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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity
• Intervention / Treatment: Behavioral: WLM3P; Behavioral: Low-carb diet

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Lisboa, Portugal, 1169-056
    • NOVA Medical School, NOVA University of Lisbon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Behavioral: WLM3P; 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).
ACTIVE_COMPARATOR: 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.	Behavioral: Low-carb diet; 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidade do Porto
• Collaborators: NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa; CINTESIS@RISE, NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 25, 2021
• Primary Completion (ACTUAL): January 20, 2023
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: December 6, 2019
• First Submitted That Met QC Criteria: December 6, 2019
• First Posted (ACTUAL): December 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Weight Loss
• Other Study ID Numbers: WLM3P01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No