Reclaiming Indigenous Food and Health

Sponsor
University of Wyoming (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03661177
Collaborator
National Institutes of Health (NIH) (NIH), National Institute of General Medical Sciences (NIGMS) (NIH)
19
1
2
31.5
0.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Sovereign nation diet
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Reclaiming Indigenous Food and Health: a Pilot RCT on Health Impacts of Sovereign Nation Diets
Actual Study Start Date :
Jan 16, 2020
Actual Primary Completion Date :
Mar 28, 2020
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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
  • No Intervention: Control

    Outcome Measures

    Primary Outcome Measures

    1. Body mass index [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.

    2. Blood pressure [Change in baseline over 5 weeks]

      Both systolic and diastolic pressures will be assessed.

    3. Waist circumference [Change in baseline over 5 weeks]

    4. Hemoglobin A1C [Change in baseline over 5 weeks]

    5. Lipid panel [Change in baseline over 5 weeks]

    Secondary Outcome Measures

    1. Mental health change [Change in baseline over 5 weeks]

      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.

    2. Physical health change [Change in baseline over 5 weeks]

      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.

    3. Food security change [Change in baseline over 5 weeks]

      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.

    4. Cultural identity change [Change in baseline over 5 weeks]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Wyoming Laramie Wyoming United States 82070

    Sponsors and Collaborators

    • University of Wyoming
    • National Institutes of Health (NIH)
    • National Institute of General Medical Sciences (NIGMS)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Wyoming
    ClinicalTrials.gov Identifier:
    NCT03661177
    Other Study ID Numbers:
    • 20180726JK02057
    First Posted:
    Sep 7, 2018
    Last Update Posted:
    May 18, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 18, 2022