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Study has not yet been approved by the local IRB in Guinea Bissau.
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| Name | Class |
|---|---|
| USDA Human Nutrition Research Center on Aging | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention 1 | Combination Product | Intervention 1 includes providing participants with a high fiber food product, protein source, high intensity sweetener and adult multivitamin. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight | Primary outcome is weight change between baseline and endline. | Week 1 - week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Adherence | Adherence to the designated intervention will be measured by self-reported dietary intake. | week 1 - week 12 |
| Change in Blood Pressure | A secondary outcome is change in blood pressure between baseline and endline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan B Roberts, PhD | Tufts University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Partnership for Health Development | Bissau | 1000 | Guinea-Bissau |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Intervention 2 | Combination Product | Intervention 2 includes providing participants with an alternative dietary fiber source, milk protein, high intensitysweetener and adult multivitamin. |
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| 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. | 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. | 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. | baseline, week 12 |
| Change in self-reported demographics | A self administered demographics survey measures education, occupation, dietary food frequency and food security. | baseline, week 12 |
| Change in Height | A secondary outcome is change in height between baseline and endline. | Week 1, week 12 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |