Reclaiming Indigenous Food and Health

NCT03661177 | Completed

• 1 other identifier: 20180726JK02057
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Overweight; Diabetes; Hypertension

Outcome Measures

Primary Outcomes (5)

• 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

• Blood pressure

  Both systolic and diastolic pressures will be assessed.

  Change in baseline over 5 weeks

• Waist circumference

  Change in baseline over 5 weeks

• Hemoglobin A1C

  Change in baseline over 5 weeks

• Lipid panel

  Change in baseline over 5 weeks

Secondary Outcomes (4)

• Mental health change

  Change in baseline over 5 weeks

• Physical health change

  Change in baseline over 5 weeks

• Food security change

  Change in baseline over 5 weeks

• Cultural identity change

  Change in baseline over 5 weeks

Study Arms (2)

Diet intervention

EXPERIMENTAL

Other: Sovereign nation diet

Control

NO INTERVENTION

Interventions

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.

Also known as: Reclaiming indigenous food and health: a pilot RCT on health impacts of sovereign nation diets

Diet intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older

You may not qualify if:

• \- Diagnosed with any disorder that causes a compromised immune system (e.g. cancer such as leukemia, HIV/AIDS)

Sponsors & Collaborators

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

Study Sites (1)

University of Wyoming

Laramie, Wyoming, 82070, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Diabetes Mellitus; Hypertension

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 7, 2018
• Study Start: January 16, 2020
• Primary Completion: March 28, 2020
• Study Completion: June 5, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)