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

N/AUnknownNCT04192357

Universidade do Porto112 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

112

Conditions

Obesity

Interventions

WLM3PBEHAVIORAL

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).

Low-carb dietBEHAVIORAL

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

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

NOVA Medical School, NOVA University of Lisbon

Lisbon, Portugal

Outcomes

Primary Outcomes

Change in weight

Difference between the intervention and control group in the change of weight from baseline to the end of follow-up.

Time frame: 18 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 18 months

Change in fasting plasma glucose concentrations

Data from ClinicalTrials.gov

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Difference between the intervention and control group in the change of serum glucose concentrations from baseline to the end of follow-up.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 18 months