Clinical trial NCT03661177: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Diabetes
Hypertension
Lead sponsor: University of Wyoming
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of General Medical Sciences (NIGMS)
First posted: 2018-09-07
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Body mass index
timeFrame: Change in baseline over 5 weeks
measure: Blood pressure
timeFrame: Change in baseline over 5 weeks
measure: Waist circumference
timeFrame: Change in baseline over 5 weeks
measure: Hemoglobin A1C
timeFrame: Change in baseline over 5 weeks
measure: Lipid panel
timeFrame: Change in baseline over 5 weeks
Secondary outcomes:
measure: Mental health change
timeFrame: Change in baseline over 5 weeks
measure: Physical health change
timeFrame: Change in baseline over 5 weeks
measure: Food security change
timeFrame: Change in baseline over 5 weeks
measure: Cultural identity change
timeFrame: Change in baseline over 5 weeks
Other outcomes:
Locations:
city: Laramie
country: United States
facility: University of Wyoming
state: Wyoming
Study officials:
References: