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NCT Number: NCT03661177

Reclaiming Indigenous Food and Health

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.

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Key information

Conditions

Obesity Body Weight Cardiovascular Diseases Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wyoming

Laramie, Wyoming, 82070, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sovereign nation diet

Other

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

Primary outcomes

  1. Body mass index

    Time frame: 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

    Time frame: Change in baseline over 5 weeks

    Both systolic and diastolic pressures will be assessed.

  3. Waist circumference

    Time frame: Change in baseline over 5 weeks

  4. Hemoglobin A1C

    Time frame: Change in baseline over 5 weeks

  5. Lipid panel

    Time frame: Change in baseline over 5 weeks

Secondary outcomes

  1. Mental health change

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Wyoming

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2024
First posted
Sep 7, 2018
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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