跳至主要内容
临床试验/NCT03661177
NCT03661177已完成不适用

Reclaiming Indigenous Food and Health: a Pilot RCT on Health Impacts of Sovereign Nation Diets

University of Wyoming2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2020年1月16日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验