Tribal Health and Resilience in Vulnerable Environments

Obesity Clinical Trial

— THRIVE  

Official title:

Tribal Health and Resilience in Vulnerable Environments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03311217
• Other study ID #: R01HL117729
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: August 1, 2017

Study information

• Verified date: September 2019
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1634
• Est. completion date: August 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Healthy retail strategies

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fruit intake	Self reported via 6 questions asking about consumption of intervention foods	9 to 12months duration depending on tribe and store
Primary	Vegetable intake	Self reported via 6 questions asking about consumption of intervention foods	9 to 12months duration depending on tribe and store