Pilot Study on Weight Loss in Guinea Bissau

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Study on Weight Loss in Guinea Bissau

Conditions
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Overweight and Obesity, Weight Loss

Intervention / Treatment
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* Combination Product: Intervention 1
* Combination Product: Intervention 2


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention 1<br>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. | Combination Product: Intervention 1<br>* Intervention 1 includes providing participants with a high fiber food product, protein source, high intensity sweetener and adult multivitamin.<br>|
| Experimental: Intervention 2<br>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. | Combination Product: Intervention 2<br>* Intervention 2 includes providing participants with an alternative dietary fiber source, milk protein, high intensitysweetener and adult multivitamin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight | Primary outcome is weight change between baseline and endline. | Week 1 - week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Adherence | Adherence to the designated intervention will be measured by self-reported dietary intake. | week 1 - week 12 | 
| Change in Blood Pressure | A secondary outcome is change in blood pressure between baseline and endline. | baseline, week 12 | 
| Change in self-reported measures of eating behavior. | Self-administered Three Factor Eating Questionnaire will be used to capture participants eating behavior between baseline and endline. | baseline, week 12 | 
| Change in self-reported measures of mood. | Self-administered Profile of Mood States Questionnaire will be used to capture participants mood between baseline and endline. | baseline, week 12 | 
| Change in self-reported measures of physical activity. | Self-administered International Physical Activity Questionnaire will be used to capture participants physical activity between baseline and endline. | baseline, week 12 | 
| Change in self-reported demographics | A self administered demographics survey measures education, occupation, dietary food frequency and food security. | baseline, week 12 | 
| Change in Height | A secondary outcome is change in height between baseline and endline. | Week 1, week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obese, Overweight, Weight loss, West Africa