Clinical trial NCT03311217: Tribal Health and Resilience in Vulnerable Environments
Official title: Tribal Health and Resilience in Vulnerable Environments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2017-10-17
Enrollment: 1634
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized trial with four communities assigned to intervention and four communities assigned to control
Primary purpose: PREVENTION

Brief summary: The THRIVE study is a healthy retail intervention that improves the food environments in tribally owned and operated convenience stores in the Chickasaw Nation and Choctaw Nation of Oklahoma.

Detailed description: The THRIVE study is a cluster randomized trial, using a community-based participatory research approach, of "healthy makeovers" in eight convenience stores owned and operated by the Chickasaw Nation and Choctaw Nation of Oklahoma. The study will test the ability of tribal nations to increase fruit and vegetable purchasing and consumption among tribal members through environmental and policy approaches. Investigators hypothesize that tribal members exposed to the highest doses of the intervention (i.e. those who visit the intervention convenience stores the most) will increase their fruit and vegetable intake. Individual-level changes in fruit and vegetable intake will be measured via a survey administered to a cohort of 1600 American Indian shoppers before and after the intervention. A multimedia manual, Website, and documentary film will be created as part of the implementation of THRIVE to engage tribal citizens, enhance local knowledge, and guide other tribes to improve their food and physical activity environments.

Eligibility criteria: Inclusion criteria

* American Indian or Alaska Native
* Residing in the tribal jurisdictional areas
* No plans of moving within 12 months
* Self-report shopping at the stores for food at least 3 times per week

Exclusion Criteria:

• Anyone who does not meet these criteria

Primary outcomes:
measure: Fruit intake
timeFrame: 9 to 12months duration depending on tribe and store
measure: Vegetable intake
timeFrame: 9 to 12months duration depending on tribe and store
Secondary outcomes:
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Valarie Jernigan, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jernigan VBB, Wetherill M, Hearod J, Jacob T, Salvatore AL, Cannady T, Grammar M, Standridge J, Fox J, Spiegel J, Wiley A, Noonan C, Buchwald D. Cardiovascular Disease Risk Factors and Health Outcomes Among American Indians in Oklahoma: the THRIVE Study. J Racial Ethn Health Disparities. 2017 Dec;4(6):1061-1068. doi: 10.1007/s40615-016-0310-4. Epub 2016 Dec 6.
citation: Blue Bird Jernigan V, Wetherill MS, Hearod J, Jacob T, Salvatore AL, Cannady T, Grammar M, Standridge J, Fox J, Spiegel J, Wiley A, Noonan C, Buchwald D. Food Insecurity and Chronic Diseases Among American Indians in Rural Oklahoma: The THRIVE Study. Am J Public Health. 2017 Mar;107(3):441-446. doi: 10.2105/AJPH.2016.303605. Epub 2017 Jan 19.