Pilot Study on Weight Loss in Guinea Bissau

Overweight and Obesity Clinical Trial

Official title:

Pilot Study on Weight Loss in Guinea Bissau

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03316742
• Other study ID #: 12377
• Status: Withdrawn
• Phase: N/A
• Start date: December 2020
• Est. completion date: January 2021

Study information

• Verified date: February 2022
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Overweight
• Overweight and Obesity
• Weight Loss

Intervention

Combination Product:
• Intervention 1
Intervention 1 includes providing participants with a high fiber food product, protein source, high intensity sweetener and adult multivitamin.
• Intervention 2
Intervention 2 includes providing participants with an alternative dietary fiber source, milk protein, high intensitysweetener and adult multivitamin.

Locations

Country	Name	City	State
Guinea-Bissau	International Partnership for Health Development	Bissau

Sponsors (2)

Lead Sponsor	Collaborator
Tufts University	USDA Human Nutrition Research Center on Aging

Country where clinical trial is conducted

Guinea-Bissau, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight	Primary outcome is weight change between baseline and endline.	Week 1 - week 12
Secondary	Intervention Adherence	Adherence to the designated intervention will be measured by self-reported dietary intake.	week 1 - week 12
Secondary	Change in Blood Pressure	A secondary outcome is change in blood pressure between baseline and endline.	baseline, week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in self-reported demographics	A self administered demographics survey measures education, occupation, dietary food frequency and food security.	baseline, week 12
Secondary	Change in Height	A secondary outcome is change in height between baseline and endline.	Week 1, week 12