Overweight and ObesityNCT03316742
Pilot Study on Weight Loss in Guinea Bissau
A study testing Intervention 1 and Intervention 2 in people with Overweight and Obesity and Weight Loss, run by Tufts University at 1 site in Guinea-Bissau.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Weight Loss
- What is being tested?
- Intervention 1 and Intervention 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGuinea-Bissau
- Study dates
- Dec 2020to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Guinea-Bissau1 site
International Partnership for Health Development
Bissau, 1000
About this study
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.
Read the 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
- Being tested
- Intervention 1, Intervention 2
- Keywords
- Obese, Overweight, Weight loss, West Africa
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention 1Combination product
Intervention 1 includes providing participants with a high fiber food product, protein source, high intensity sweetener and adult multivitamin.
Intervention 2Combination product
Intervention 2 includes providing participants with an alternative dietary fiber source, milk protein, high intensitysweetener and adult multivitamin.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Combination Product: Intervention 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight
Primary outcome is weight change between baseline and endline.
Measured: Week 1 - week 12
Secondary outcomes (7)
Intervention Adherence
Adherence to the designated intervention will be measured by self-reported dietary intake.
Measured: week 1 - week 12
Change in Blood Pressure
A secondary outcome is change in blood pressure between baseline and endline.
Measured: baseline, week 12
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.
Measured: baseline, week 12
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.
Measured: baseline, week 12
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.
Measured: baseline, week 12
Change in self-reported demographics
A self administered demographics survey measures education, occupation, dietary food frequency and food security.
Measured: baseline, week 12
Change in Height
A secondary outcome is change in height between baseline and endline.
Measured: Week 1, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study startDec 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionJan 2021 (estimated)
Why it stopped: Study has not yet been approved by the local IRB in Guinea Bissau.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- USDA Human Nutrition Research Center on Aging
- Responsible party
- Principal investigator, Susan Roberts, Tufts University
- Investigators
- Susan B Roberts, PhD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316742
- Sponsor's protocol ID
- 12377
- Status last verified
- Feb 2022
- First submitted
- 13 Oct 2017
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Weight Loss in Guinea Bissau
- ClinicalTrials.gov ID
- NCT03316742
- Acronym / sponsor ID
- 12377
- Conditions
- Overweight and Obesity, Weight Loss
- Keywords
- Obese, Overweight, Weight loss, West Africa
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study has not yet been approved by the local IRB in Guinea Bissau.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- USDA Human Nutrition Research Center on Aging
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention 1 | Experimental | Combination Product: Intervention 1Participants 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. |
| Intervention 2 | Experimental | Combination Product: Intervention 2Participants 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention 1Intervention 1 includes providing participants with a high fiber food product, protein source, high intensity sweetener and adult multivitamin. | Combination product | Intervention 1 |
| Intervention 2Intervention 2 includes providing participants with an alternative dietary fiber source, milk protein, high intensitysweetener and adult multivitamin. | Combination product | Intervention 2 |
Primary outcome
Change in weight
Time frame: Week 1 - week 12
Primary outcome is weight change between baseline and endline.
7 secondary outcomes
Intervention Adherence
Time frame: week 1 - week 12
Change in Blood Pressure
Time frame: baseline, week 12
Change in self-reported measures of eating behavior.
Time frame: baseline, week 12
Change in self-reported measures of mood.
Time frame: baseline, week 12
Change in self-reported measures of physical activity.
Time frame: baseline, week 12
Change in self-reported demographics
Time frame: baseline, week 12
Change in Height
Time frame: Week 1, week 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan B Roberts, PhD principal investigator
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention 1 and Intervention 2 in people with Overweight and Obesity and Weight Loss, run by Tufts University at 1 site in Guinea-Bissau.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guinea-Bissau. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight (time frame: Week 1 - week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.