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Reclaiming Indigenous Food and Health

Primary Purpose

Obesity, Overweight, Diabetes

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sovereign nation diet
Sponsored by
University of Wyoming
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Wyoming

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Diet intervention

Control

Arm Description

Outcomes

Primary Outcome Measures

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.
Blood pressure
Both systolic and diastolic pressures will be assessed.
Waist circumference
Hemoglobin A1C
Lipid panel

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
September 4, 2018
Last Updated
February 24, 2023
Sponsor
University of Wyoming
Collaborators
National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT03661177
Brief Title
Reclaiming Indigenous Food and Health
Official Title
Reclaiming Indigenous Food and Health: a Pilot RCT on Health Impacts of Sovereign Nation Diets
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 16, 2020 (Actual)
Primary Completion Date
March 28, 2020 (Actual)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wyoming
Collaborators
National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Diabetes, Hypertension

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diet intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Sovereign nation diet
Other Intervention Name(s)
Reclaiming indigenous food and health: a pilot RCT on health impacts of sovereign nation diets
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body mass index
Description
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.
Time Frame
Change in baseline over 5 weeks
Title
Blood pressure
Description
Both systolic and diastolic pressures will be assessed.
Time Frame
Change in baseline over 5 weeks
Title
Waist circumference
Time Frame
Change in baseline over 5 weeks
Title
Hemoglobin A1C
Time Frame
Change in baseline over 5 weeks
Title
Lipid panel
Time Frame
Change in baseline over 5 weeks
Secondary Outcome Measure Information:
Title
Mental health change
Description
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.
Time Frame
Change in baseline over 5 weeks
Title
Physical health change
Description
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.
Time Frame
Change in baseline over 5 weeks
Title
Food security change
Description
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.
Time Frame
Change in baseline over 5 weeks
Title
Cultural identity change
Description
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.
Time Frame
Change in baseline over 5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Facility Information:
Facility Name
University of Wyoming
City
Laramie
State/Province
Wyoming
ZIP/Postal Code
82070
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

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Reclaiming Indigenous Food and Health

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