Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2020-12-31
2021-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention 1
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.
Intervention 1
Intervention 1 includes providing participants with a high fiber food product, protein source, high intensity sweetener and adult multivitamin.
Intervention 2
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.
Intervention 2
Intervention 2 includes providing participants with an alternative dietary fiber source, milk protein, high intensitysweetener and adult multivitamin.
Interventions
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Intervention 1
Intervention 1 includes providing participants with a high fiber food product, protein source, high intensity sweetener and adult multivitamin.
Intervention 2
Intervention 2 includes providing participants with an alternative dietary fiber source, milk protein, high intensitysweetener and adult multivitamin.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
65 Years
ALL
Yes
Sponsors
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USDA Human Nutrition Research Center on Aging
FED
Tufts University
OTHER
Responsible Party
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Susan Roberts
Director and Senior Scientist
Principal Investigators
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Susan B Roberts, PhD
Role: PRINCIPAL_INVESTIGATOR
Tufts University
Locations
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International Partnership for Health Development
Bissau, , Guinea-Bissau
Countries
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Other Identifiers
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12377
Identifier Type: -
Identifier Source: org_study_id
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