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Pilot Study on Weight Loss in Guinea Bissau

Primary Purpose

Overweight and Obesity, Weight Loss

Status

Withdrawn

Phase

Not Applicable

Locations

Guinea-Bissau

Study Type

Interventional

Intervention

Intervention 1

Intervention 2

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring Obese, Overweight, Weight loss, West Africa

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

International Partnership for Health Development

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Intervention 1

Intervention 2

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in weight

Primary outcome is weight change between baseline and endline.

Secondary Outcome Measures

Intervention Adherence

Adherence to the designated intervention will be measured by self-reported dietary intake.

Change in Blood Pressure

A secondary outcome is change in blood pressure between baseline and endline.

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.

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.

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.

Change in self-reported demographics

A self administered demographics survey measures education, occupation, dietary food frequency and food security.

Change in Height

A secondary outcome is change in height between baseline and endline.

Full Information

NCT ID

NCT03316742

First Posted

October 13, 2017

Last Updated

February 22, 2022

Sponsor

Tufts University

Collaborators

USDA Human Nutrition Research Center on Aging

1. Study Identification

Unique Protocol Identification Number

NCT03316742

Brief Title

Pilot Study on Weight Loss in Guinea Bissau

Official Title

Pilot Study on Weight Loss in Guinea Bissau

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Study has not yet been approved by the local IRB in Guinea Bissau.

Study Start Date

December 2020 (Anticipated)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tufts University

Collaborators

USDA Human Nutrition Research Center on Aging

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight and Obesity, Weight Loss

Keywords

Obese, Overweight, Weight loss, West Africa

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention 1

Arm Type

Experimental

Arm Description

Arm Title

Intervention 2

Arm Type

Experimental

Arm Description

Intervention Type

Combination Product

Intervention Name(s)

Intervention 1

Intervention Description

Intervention 1 includes providing participants with a high fiber food product, protein source, high intensity sweetener and adult multivitamin.

Intervention Type

Combination Product

Intervention Name(s)

Intervention 2

Intervention Description

Intervention 2 includes providing participants with an alternative dietary fiber source, milk protein, high intensitysweetener and adult multivitamin.

Primary Outcome Measure Information:

Title

Change in weight

Description

Primary outcome is weight change between baseline and endline.

Time Frame

Week 1 - week 12

Secondary Outcome Measure Information:

Title

Intervention Adherence

Description

Adherence to the designated intervention will be measured by self-reported dietary intake.

Time Frame

week 1 - week 12

Title

Change in Blood Pressure

Description

A secondary outcome is change in blood pressure between baseline and endline.

Time Frame

baseline, week 12

Title

Change in self-reported measures of eating behavior.

Description

Self-administered "Three Factor Eating Questionnaire" will be used to capture participants eating behavior between baseline and endline.

Time Frame

baseline, week 12

Title

Change in self-reported measures of mood.

Description

Self-administered "Profile of Mood States Questionnaire" will be used to capture participants mood between baseline and endline.

Time Frame

baseline, week 12

Title

Change in self-reported measures of physical activity.

Description

Self-administered "International Physical Activity Questionnaire" will be used to capture participants physical activity between baseline and endline.

Time Frame

baseline, week 12

Title

Change in self-reported demographics

Description

A self administered demographics survey measures education, occupation, dietary food frequency and food security.

Time Frame

baseline, week 12

Title

Change in Height

Description

A secondary outcome is change in height between baseline and endline.

Time Frame

Week 1, week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susan B Roberts, PhD

Organizational Affiliation

Tufts University

Official's Role

Principal Investigator

Facility Information:

Facility Name

International Partnership for Health Development

City

Bissau

ZIP/Postal Code

1000

Country

Guinea-Bissau

12. IPD Sharing Statement

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Pilot Study on Weight Loss in Guinea Bissau

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