Pilot Study on Weight Loss in Guinea Bissau

Tufts University

Status: Withdrawn

Conditions: Weight Loss; Overweight and Obesity

Treatments: Combination Product: Intervention 2; Combination Product: Intervention 1

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03316742

12377

Details and patient eligibility

About

The purpose of this study is to test two versions a weight loss program potentially suitable for implementation in Africa. A successful method would have widespread application in low-income countries, with the potential to improve world health.

Full description

Specific Aim 1 is to conduct a 3-4 month pilot study randomizing participants to two versions of a weight loss program. The program will be implemented in a convenience sample of overweight and obese adults living in Guinea-Bissau and measure changes in body weight loss (primary outcome), adherence to program recommendations including recommended food patterns, blood pressure, eating behavior, physical activity and mood (secondary outcomes). The data will be used to refine the weight loss program and conduct power calculations for a future trial.

Specific Aim 2 is to analyze associations between weight loss, participant demographics and program metrics, to explore reasons for differences in weight loss between participants. Factors to be tested include participant BMI, gender and age, as well as adherence to meal portion recommendations, use of sugar-sweetened beverages and provided foods, and physical activity.

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men and women who are overweight or obese (BMI ≥25 kg/m2).
• Want to lose weight, want to enroll in the study and are willing to sign the informed consent form.
• Anticipate being able to meet the study requirements for food habits and study meetings, and anticipate remaining in Bissau for the study duration.
• Between the ages of 20 to 65 years.
• Non-pregnant women, and those who do not intend on becoming pregnant during the course of the study.
• A doctor or nurse has signed a note approving participant in the weight loss intervention after seeing a copy of the handout with title "Instructions for Bissau Weight Loss Pilot Project", and a copy of his/her approval is given to the research staff.

Exclusion criteria

• Report food allergies or intolerance or health conditions that would prevent consumption of provided and recommended foods.
• Participation in another concurrent nutrition research study.
• If premenopausal (<55 years of age), they are pregnant or intend to become pregnant during the course of the study, or are not using a birth control method to prevent pregnancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Intervention 1

Experimental group

Description:

Participants randomized to intervention 1 will complete baseline and endline outcomes and participate in version 1 of a weight loss program. Each participant will attend twelve one hour classes discussing weight loss adherence in addition to barriers experienced. Changes in weight will be recorded throughout the study.

Treatment:

Combination Product: Intervention 1

Intervention 2

Experimental group

Description:

Participants randomized to intervention 2 will complete baseline and endline outcomes and participate in version 2 of a weight loss program. Each participant will attend 12 one hour classes discussing weight loss adherence in addition to barriers experienced. Changes in weight will be recorded throughout the study.

Treatment:

Combination Product: Intervention 2