Pilot Study on Weight Loss in Guinea Bissau
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in weight
时间窗: Week 1 - week 12
Primary outcome is weight change between baseline and endline.
次要结局
- Intervention Adherence(week 1 - week 12)
- Change in self-reported demographics(baseline, week 12)
- Change in self-reported measures of physical activity.(baseline, week 12)
- Change in Height(Week 1, 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 Blood Pressure(baseline, week 12)
研究者
Susan Roberts
Director and Senior Scientist
Tufts University