Reclaiming Indigenous Food and Health

• ClinicalTrials.gov Identifier: NCT03661177
• Recruitment Status: Active, not recruiting
• First Posted: September 7, 2018
• Last Update Posted: April 28, 2021
• Sponsor: University of Wyoming
• Collaborators: National Institutes of Health (NIH); National Institute of General Medical Sciences (NIGMS)
• Information provided by (Responsible Party): University of Wyoming

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
Obesity; Overweight; Diabetes; Hypertension	Other: Sovereign nation diet	Not Applicable

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 (Clinical Trial)
• 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: January 16, 2020
• Actual Primary Completion Date: March 28, 2020
• Estimated Study Completion Date: September 2021

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 Name: 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 [ 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 Outcome Measures :

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.

Eligibility Criteria

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

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)

Contacts and Locations

Locations

United States, Wyoming

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)

More Information

• Responsible Party: University of Wyoming
• ClinicalTrials.gov Identifier: NCT03661177
• Other Study ID Numbers: 20180726JK02057
• First Posted: September 7, 2018
• Last Update Posted: April 28, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Overweight; Body Weight