An interventional study of Intervention 1 and Intervention 2 in Overweight and Obesity and Weight Loss, sponsored by Tufts University. Withdrawn at 1 site in Guinea-Bissau. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-23.
Sponsored by Tufts University · Not applicable, Interventional, and Treatment
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.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
Browse Obesity studies →Tufts University is the lead sponsor of 228 studies on the registry; 23 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Intervention 1 includes providing participants with a high fiber food product, protein source, high intensity sweetener and adult multivitamin.
Intervention 2 includes providing participants with an alternative dietary fiber source, milk protein, high intensitysweetener and adult multivitamin.
Change in weight
Primary outcome is weight change between baseline and endline.
Time frame: Week 1 - week 12
Intervention Adherence
Adherence to the designated intervention will be measured by self-reported dietary intake.
Time frame: week 1 - week 12
Change in Blood Pressure
A secondary outcome is change in blood pressure between baseline and endline.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, week 12
Change in self-reported demographics
A self administered demographics survey measures education, occupation, dietary food frequency and food security.
Time frame: baseline, week 12
Change in Height
A secondary outcome is change in height between baseline and endline.
Time frame: Week 1, week 12
Start is estimated for Dec 2020; primary completion for Dec 2020, 0 months later.
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This study is withdrawn, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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