NCT03316742

Pilot Study on Weight Loss in Guinea Bissau

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Tufts University · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Overweight and Obesity
• Weight Loss

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Intervention 1	Intervention 1 includes providing participants with a high fiber food product, protein source, high intensity sweetener and adult multivitamin.
COMBINATION_PRODUCT	Intervention 2	Intervention 2 includes providing participants with an alternative dietary fiber source, milk protein, high intensitysweetener and adult multivitamin.

Timeline

• Start date: 2020-12-01
• Primary completion: 2020-12-01
• Completion: 2021-01-01
• First posted: 2017-10-20
• Last updated: 2022-02-23

Locations

1 site across 1 country: Guinea-Bissau