Reclaiming Indigenous Food and Health

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypertension; Obesity; Diabetes; Overweight
• Intervention / Treatment: Other: Sovereign nation diet

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wyoming
    • Laramie, Wyoming, United States, 82070
      • University of Wyoming

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Diet intervention	Other: Sovereign nation diet; 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.; Other Names: Reclaiming indigenous food and health: a pilot RCT on health impacts of sovereign nation diets

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

Collaborators and Investigators

• Sponsor: University of Wyoming
• Collaborators: National Institutes of Health (NIH); National Institute of General Medical Sciences (NIGMS)

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2020
• Primary Completion (Actual): March 28, 2020
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: September 6, 2018
• First Posted (Actual): September 7, 2018

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 24, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: 20180726JK02057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: PD will be made available to each individual participant, but otherwise only the data summaries will be made available to non-partner parties unless individually arranged and approved by the IRB and project Advisory Board (Restoring Shoshone Ancestral Food Gathering group). The Eastern Shoshone tribe co-owns the data with the research team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No