Tribal Health and Resilience in Vulnerable Environments

NCT03311217 | Completed DMC

• 1 other identifier: R01HL117729
• Study Type: interventional
• Target: 1,634
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Fruit intake

  Self reported via 6 questions asking about consumption of intervention foods

  9 to 12months duration depending on tribe and store

• Vegetable intake

  Self reported via 6 questions asking about consumption of intervention foods

  9 to 12months duration depending on tribe and store

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Healthy retail strategies BEHAVIORAL

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Anyone who does not meet these criteria

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Tulsa, Oklahoma, 74105, United States

Location

Related Publications (2)

• 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.

  PMID: 27924618 BACKGROUND

• 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.

  PMID: 28103070 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Valarie Jernigan, DrPH

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized trial with four communities assigned to intervention and four communities assigned to control

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: October 17, 2017
• Study Start: June 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: September 27, 2019

Record last verified: 2019-09

Locations

US (1)