Tribal Health and Resilience in Vulnerable Environments

NCT ID: NCT03311217

Last Updated: 2019-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1634 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2017-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomized trial with four communities assigned to intervention and four communities assigned to control
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Healthy retail strategies

Intervention Type BEHAVIORAL

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Healthy retail strategies

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Valarie Jernigan, DrPH

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Oklahoma Health Sciences Center

Tulsa, Oklahoma, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 27924618 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28103070 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01HL117729

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Med-South Lifestyle Study: Phase 1
NCT04421703 COMPLETED NA
The Okla Achokma Project
NCT06633939 COMPLETED NA
It's Native: Nudging Healthy Ways
NCT05470296 WITHDRAWN NA