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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-25

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

WLM3P

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Low-carb diet

Intervention Type BEHAVIORAL

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).

Interventions

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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).

Intervention Type 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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes