Back to resultsA Randomised Controlled Trial of a Weight Loss Maintenance Program for Adults With Obesity: The WLM3P Study (WLM3P)
Primary Purpose
Obesity
Status
Active
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
WLM3P
Low-carb diet
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
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
Sites / Locations
- NOVA Medical School, NOVA University of Lisbon
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
WLM3P
Low-carb diet
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in weight
Difference between the intervention and control group in the change of weight from baseline to the end of follow-up.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04192357
First Posted
December 6, 2019
Last Updated
February 3, 2023
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
1. Study Identification
Unique Protocol Identification Number
NCT04192357
Brief Title
A Randomised Controlled Trial of a Weight Loss Maintenance Program for Adults With Obesity: The WLM3P Study
Acronym
WLM3P
Official Title
A Randomised Controlled Trial of a Weight Loss Maintenance Program for Adults With Obesity: The WLM3P Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 25, 2021 (Actual)
Primary Completion Date
January 20, 2023 (Actual)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the 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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WLM3P
Arm Type
Experimental
Arm Description
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.
Arm Title
Low-carb diet
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
WLM3P
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Low-carb diet
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in weight
Description
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 Outcome Measure Information:
Title
Change in total fat mass
Description
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
Title
Change in waist circumference
Description
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
Title
Change in body mass index
Description
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
Title
Change in systolic and diastolic blood pressure
Description
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
Title
Change in intestinal microbiota
Description
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
Title
Change in fasting plasma glucose concentrations
Description
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
Title
Change in fasting plasma insulin concentrations
Description
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
Title
Change in fasting plasma triglycerides concentrations
Description
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
Title
Change in fasting plasma low density lipoprotein (LDL) concentrations
Description
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
Title
Change in fasting plasma high density lipoprotein (HDL) concentrations
Description
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
Title
Change in fasting plasma glycated hemoglobin A1c (HbA1c) concentrations
Description
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
Title
Change in alanine aminotransferase (ALT) concentrations
Description
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
Title
Change in aspartate aminotransferase (AST) concentrations
Description
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
Title
Change in gamma-glutamyl transpeptidase (GGT) concentrations
Description
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
Title
Change in HOMA-IR
Description
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
Title
Change in creatinine concentrations
Description
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
Title
Change in vitamin D concentrations
Description
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
Title
Change in high-sensitivity C-reactive protein (hs-CRP) concentrations
Description
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
Title
Change in sodium concentrations
Description
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
Title
Change in potassium concentrations
Description
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
Title
Change in magnesium concentrations
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Conceição Calhau, PhD
Organizational Affiliation
CINTESIS, NOVA Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
NOVA Medical School, NOVA University of Lisbon
City
Lisboa
ZIP/Postal Code
1169-056
Country
Portugal
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Randomised Controlled Trial of a Weight Loss Maintenance Program for Adults With Obesity: The WLM3P Study
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