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CompletedNCT03311217THRIVEUpdated Sep 27, 2019

Tribal Health and Resilience in Vulnerable Environments

An interventional study of Healthy retail strategies in Obesity, sponsored by University of Oklahoma. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-27.

Sponsored by University of Oklahoma · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,634
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Anyone who does not meet these criteria
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,634 participants (actual)

Study arms

  • Experimental
    Intervention group

    Healthy retail strategies will be implemented in tribally owned convenience stores in these communities. Specific strategies include pricing discounts, promotional signage, incorporation of new product, and placement of healthier items on shelves.

    Behavioral: Healthy retail strategies

  • No intervention
    Control group

    No intervention will be implemented in the stores in the control communities.

Interventions

  • BehavioralHealthy retail strategies
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What researchers measure

Primary outcomes

  1. Fruit intake

    Self reported via 6 questions asking about consumption of intervention foods

    Time frame: 9 to 12months duration depending on tribe and store

  2. Vegetable intake

    Self reported via 6 questions asking about consumption of intervention foods

    Time frame: 9 to 12months duration depending on tribe and store

06

Study locations

1 site
  • University of Oklahoma Health Sciences Center
    Tulsa, Oklahoma 74105, United States
07

References and documents

Publications

  • 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. PubMed 27924618 ↗
  • 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. PubMed 28103070 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03311217
Lead sponsor
University of Oklahoma
Responsible party
Sponsor
First posted
Oct 17, 2017
Start date
Jun 1, 2016
Primary completion
Aug 1, 2017
Completion
Aug 1, 2017
Last update
Sep 27, 2019

Study contacts

Valarie Jernigan, DrPH
principal investigator · University of Oklahoma

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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