Chickasaw Healthy Eating Environments Research Study

NCT03774277 | Completed DMC

• 1 other identifier: 7614
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

Brief Summary

This study, the Chickasaw Healthy Eating Environments Research Study (CHEERS), will be conducted in partnership with Chickasaw Nation. CHEERS comprises several mutually reinforcing strategies to improve blood pressure (BP) control in people with hypertension. Environmental strategies include the investigator's innovative "Packed Promise for a Healthy Heart" program that provides hypertensive adults ages 18 and older with a voucher for fresh vegetables and fruits (referred to as a "fresh check") and home delivered food boxes that contain Dietary Approaches to Stop Hypertension (DASH)-approved ingredients for preparing low-salt, and traditional healthy Chickasaw meals. The study facilitates demonstrations of healthy cooking practices in participating communities. At the individual level, tribal members with uncontrolled hypertension will receive heart-healthy recipes (available at getfreshcooking.com) that are tailored to traditional Chickasaw diet and culture, educational materials, along with invitations to attend cooking demonstrations, fresh checks to improve access to fresh produce, and a Chickasaw Nation culturally-informed smartphone walking app called "AYA." At the policy level, CHEERS will culminate in a multimedia documentary presentation for tribal leadership detailing the intervention and featuring personal success stories by hypertensive community members. Study findings, including a health economics assessment, will be used to encourage policies for further expansion of the Packed Promise for a Healthy Heart Program; and policies promoting expansion of brick and mortar grocery outlets in rural Chickasaw communities.

Conditions

Blood Pressure; Body Weight

Keywords

Hypertension; Blood Pressure; DASH-Diet; BMI; American Indian; Food Environment; CBPR; CHEERS; Native American

Outcome Measures

Primary Outcomes (1)

• Change in systolic blood pressure

  Targeted 2.9 mm Hg decrease in systolic blood pressure

  Measured before and after the 6 month intervention

Secondary Outcomes (3)

• Food security

  Measured before and after the 6 month intervention

• Diet

  Measured before and after the 6 month intervention

• Change in body mass index

  Measured before and after the 6 month intervention

Study Arms (2)

Intervention Communities

EXPERIMENTAL

Packed Promise for a Healthy Heart intervention, free Tribal Wellness Center membership, a Fitbit, and the AYA culturally based mobile walking app.

Behavioral: Packed Promise for a Healthy Heart

Control Communities

NO INTERVENTION

Free Tribal Wellness Center membership, Fitbit, and the AYA culturally based mobile walking app

Interventions

Packed Promise for a Healthy Heart BEHAVIORAL

Voucher for fresh vegetables and fruits (referred to as a "fresh check"); Home delivered food boxes that contain Dietary Approaches to Stop Hypertension (DASH)-approved ingredients for preparing low-salt, and traditional healthy Chickasaw meals; Heart-healthy recipes (available at getfreshcooking.com) that are tailored to traditional Chickasaw diet and culture; Educational materials; Personalized invitation to attend local cooking demonstrations; Assistance to link the Fitbit and AYA app

Intervention Communities

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old
• Self-identify as American Indian/Alaska Native
• Currently reside in the four communities and do not plan on moving for 12 months
• Not currently pregnant, or ≥ 6 weeks postpartum
• Ability to understand written and spoken English
• Ability and willingness to follow study protocols
• Self-reported previous diagnosis of hypertension by a medical professional and a measured systolic BP ≥ 130 mm Hg at time of enrollment or no previous hypertension diagnosis and a measured systolic BP ≥ 130 mm Hg at both the initial screening and prior to finalizing enrollment (i.e. on two separate days)

Sponsors & Collaborators

• Oklahoma State University Center for Health Sciences: lead
• The Chickasaw Nation: collaborator
• Washington State University: collaborator

Study Sites (1)

The Chickasaw Nation

Ada, Oklahoma, 74820, United States

Location

MeSH Terms

Conditions

Body Weight; Hypertension

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Valarie BB Jernigan, DrPH, MPH

  Oklahoma State University Center for Health Sciences

  PRINCIPAL INVESTIGATOR

• Joy Standridge, MPH

  The Chickasaw Nation

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: December 12, 2018
• Study Start: July 10, 2018
• Primary Completion: December 24, 2020
• Study Completion: December 24, 2020
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)