Clinical trial NCT03316742: Pilot Study on Weight Loss in Guinea Bissau
Official title: Pilot Study on Weight Loss in Guinea Bissau
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Overweight and Obesity
Weight Loss
Keywords: Obese
Overweight
Weight loss
West Africa
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: USDA Human Nutrition Research Center on Aging
First posted: 2017-10-20
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in weight
timeFrame: Week 1 - week 12
Secondary outcomes:
measure: Intervention Adherence
timeFrame: week 1 - week 12
measure: Change in Blood Pressure
timeFrame: baseline, week 12
measure: Change in self-reported measures of eating behavior.
timeFrame: baseline, week 12
measure: Change in self-reported measures of mood.
timeFrame: baseline, week 12
measure: Change in self-reported measures of physical activity.
timeFrame: baseline, week 12
measure: Change in self-reported demographics
timeFrame: baseline, week 12
measure: Change in Height
timeFrame: Week 1, week 12
Other outcomes:
Locations:
city: Bissau
country: Guinea-Bissau
facility: International Partnership for Health Development
Study officials:
affiliation: Tufts University
name: Susan B Roberts, PhD
role: PRINCIPAL_INVESTIGATOR
References: