Reclaiming Indigenous Food and Health: a Pilot RCT on Health Impacts of Sovereign Nation Diets
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Waist circumference
研究概览
简要总结
The overall purpose of this proposed action-research project is to measure the feasibility of consuming and the impact of indigenous plants and foods on health outcomes among Native American participants.
详细描述
The overall purpose of this proposed action-research project is to measure the feasibility of consuming and the impact of indigenous plants and foods on health outcomes among Native American participants on the Wind River Indian Reservation (WRIR) in Wyoming.
Participants from the WRIR will be recruited to pilot a randomized control trial (RCT) with a delayed intervention to measure the impacts of consuming a diet that is 50% indigenous foods (based on participant total energy needs and recommended dietary pattern). Specific objectives of the pilot RCT will be to: (1) evaluate the feasibility of access, collection, and consumption of indigenous plants/animals, (2) define precisely what constitutes a "50% indigenous food diet" that will be supplied as the intervention in this trial, (3) quantify the time commitment and logistical challenges to access and collect indigenous foods, (4) evaluate the consumption of indigenous foods on health outcomes including waist circumference, body mass index, blood pressure, blood glucose control, and blood lipid levels, and (5) evaluate the impact of consuming indigenous foods on cultural identity.
The pilot RCT will primarily address objectives 4 and 5. In order to meet these specific objectives, the investigators will pilot a RCT with delayed intervention to provisionally assess health impacts of consuming a diet that is 50% indigenous foods for four weeks. Health outcomes assessed will include biometric measures of waist circumference, body mass index, blood pressure, hemoglobin A1C, total cholesterol with triglycerides; and survey measures of quality of life, cultural identification, and food security.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •self-identify as living within the boundaries of WRIR (including the city of Riverton)
- •self-identify as an enrolled member of the Eastern Shoshone or Shoshone Bannock tribe
- •be interested in following a 50% traditional diet for 4 weeks
- •18 years of age or older
排除标准
- •Diagnosed with any disorder that causes a compromised immune system (e.g. cancer such as leukemia, HIV/AIDS)
结局指标
主要结局
Waist circumference
时间窗: Change in baseline over 5 weeks
Hemoglobin A1C
时间窗: Change in baseline over 5 weeks
Lipid panel
时间窗: Change in baseline over 5 weeks
Body mass index
时间窗: Change in baseline over 5 weeks
Body mass index (using height and weight) will be measured using a portable stadiometer (to measure height) + Tanita Analyzer (to measure weight). Body mass index parameters for health (i.e. healthy weight is equivalent to a BMI between 18.5-24.9) will be evaluated.
Blood pressure
时间窗: Change in baseline over 5 weeks
Both systolic and diastolic pressures will be assessed.
次要结局
- Cultural identity change(Change in baseline over 5 weeks)
- Mental health change(Change in baseline over 5 weeks)
- Physical health change(Change in baseline over 5 weeks)
- Food security change(Change in baseline over 5 weeks)
