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

Universidade do Porto

Status: Active, not recruiting

Conditions: Obesity

Treatments: Behavioral: Low-carb diet; Behavioral: WLM3P

Study type: Interventional

Funder types: Other

Identifiers

NCT04192357

WLM3P01

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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112 participants in 2 patient groups

WLM3P

Experimental group

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.

Treatment:

Behavioral: WLM3P

Low-carb diet

Active Comparator group

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.

Treatment:

Behavioral: Low-carb diet