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

Obesity Clinical Trial

— WLM3P  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04192357
• Other study ID #: WLM3P01
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 25, 2021
• Est. completion date: June 2023

Study information

• Verified date: February 2023
• Source: Universidade do Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 112
• Est. completion date: June 2023
• Est. primary completion date: January 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

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).
• 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).

Locations

Country	Name	City	State
Portugal	NOVA Medical School, NOVA University of Lisbon	Lisboa

Sponsors (3)

Lead Sponsor	Collaborator
Universidade do Porto	CINTESIS@RISE, NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa, NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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