Reclaiming Indigenous Food and Health

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03661177
• Other study ID #: 20180726JK02057
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 16, 2020
• Est. completion date: August 2023

Study information

• Verified date: February 2023
• Source: University of Wyoming
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 19
• Est. completion date: August 2023
• Est. primary completion date: March 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes
• Hypertension
• Obesity
• Overweight

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.

Locations

Country	Name	City	State
United States	University of Wyoming	Laramie	Wyoming

Sponsors (3)

Lead Sponsor	Collaborator
University of Wyoming	National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Blood pressure	Both systolic and diastolic pressures will be assessed.	Change in baseline over 5 weeks
Primary	Waist circumference		Change in baseline over 5 weeks
Primary	Hemoglobin A1C		Change in baseline over 5 weeks
Primary	Lipid panel		Change in baseline over 5 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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