NCT03316742

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 20, 2017

Completed
3.1 years until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

February 23, 2022

Status Verified

February 1, 2022

Enrollment Period

Same day

First QC Date

October 13, 2017

Last Update Submit

February 22, 2022

Conditions

Overweight and ObesityWeight Loss

Keywords

ObeseOverweightWeight lossWest Africa

Outcome Measures

Primary Outcomes (1)

  • Change in weight

    Primary outcome is weight change between baseline and endline.

    Week 1 - week 12

Secondary Outcomes (7)

  • Intervention Adherence

    week 1 - week 12

  • Change in Blood Pressure

    baseline, week 12

  • Change in self-reported measures of eating behavior.

    baseline, week 12

  • Change in self-reported measures of mood.

    baseline, week 12

  • Change in self-reported measures of physical activity.

    baseline, week 12

  • +2 more secondary outcomes

Study Arms (2)

Intervention 1

EXPERIMENTAL

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

Intervention 2

EXPERIMENTAL

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

Interventions

Intervention 1COMBINATION_PRODUCT

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

Intervention 1
Intervention 2COMBINATION_PRODUCT

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

Intervention 2

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Partnership for Health Development

Bissau, 1000, Guinea-Bissau

Location

MeSH Terms

Conditions

OverweightObesityWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Susan B Roberts, PhD

    Tufts University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director and Senior Scientist

Study Record Dates

First Submitted

October 13, 2017

First Posted

October 20, 2017

Study Start

December 1, 2020

Primary Completion

December 1, 2020

Study Completion

January 1, 2021

Last Updated

February 23, 2022

Record last verified: 2022-02

Locations

GU(1)