Reclaiming Indigenous Food and Health

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Obesity, Overweight, Diabetes, Hypertension

Intervention / Treatment
-----------------
* Other: Sovereign nation diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: - Diagnosed with any disorder that causes a compromised immune system (e.g. cancer such as leukemia, HIV/AIDS)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet intervention<br> | Other: Sovereign nation diet<br>* We will pilot a RCT with delayed intervention to provisionally assess health impacts of consuming a diet that is 50% indigenous foods for four weeks.<br>* Other names: Reclaiming indigenous food and health: a pilot RCT on health impacts of sovereign nation diets;|
| No Intervention: Control<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index | 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. | Change in baseline over 5 weeks | 
| Blood pressure | Both systolic and diastolic pressures will be assessed. | Change in baseline over 5 weeks | 
| Waist circumference |  | Change in baseline over 5 weeks | 
| Hemoglobin A1C |  | Change in baseline over 5 weeks | 
| Lipid panel |  | Change in baseline over 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental health change | Measured by 2 statements or questions about general mental health. For each question/statement, participants respond to a 5 point scale (1= none of the time, 5 = all of the time). Statements may be reverse scored for analysis resulting in a higher value indicating a positive change in mental health. | Change in baseline over 5 weeks | 
| Physical health change | Measured by 12 statements or questions about general health. For each question/statement, participants respond to a 5 point scale (1= none of the time or poor, 5 = all of the time or excellent). A high value on the scale would indicate a positive change in physical health. | Change in baseline over 5 weeks | 
| Food security change | Measured by 8 statements that people have made about their food situation. For these statements, participants indicate whether the statement was often true, sometimes true, or never true for your household in the last four weeks. Statements will be scored (1=never true, 2 = sometimes true, 3 = often true). Statements may be reverse scored for analysis resulting in a higher value indicating a positive change in food security. | Change in baseline over 5 weeks | 
| Cultural identity change | Measured by survey questions related to experiences of traditional Native American people. Each item is rated by participants in terms of how much they have participated in each activity (1 = not at all, 7 = a great deal). A high value on the scale would indicate a positive change in cultural identity. | Change in baseline over 5 weeks |