Chickasaw Healthy Eating Environments Research Study (CHEERS)

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.

Study Overview

• Status: Unknown
• Conditions: Body Weight; Blood Pressure
• Intervention / Treatment: Behavioral: Packed Promise for a Healthy Heart

Detailed Description

This study is guided by the principles of community-based participatory research (CBPR).

Aims and Methods: Co-led by an AI (Choctaw) Investigator, the study will:

Aim #1: Evaluate CHEERS' ability to improve healthy food access by collecting quantitative data on changes in perceived ability to purchase and prepare healthy food, and by using qualitative methods to evaluate the reach, saturation, and acceptability of the CHEERS intervention.

Aim #2: Measure the intervention's effect on change in BP and secondary outcomes among hypertensive community members with poorly controlled hypertension.

Aim #3:Disseminate a multimedia documentary of the study's findings and evaluate the documentary's effect on tribal leaders across the Chickasaw Nation and other tribal communities.

Innovation: This study will evaluate the effects of a multilevel, tribally-run, food environment intervention. The study will also be one of the few food environment interventions ever implemented in an AI community, and the first to objectively measure its effects on BP and BMI.

Significance and Impact: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cassandra D Camp, MPH; Phone Number: 918-561-1576; Email: cdcamp@okstate.edu
• Study Contact Backup: Name: Charlotte Love, MPH; Phone Number: 918-978-5957; Email: charlie.love@okstate.edu

Study Locations

• United States
  • Oklahoma
    • Ada, Oklahoma, United States, 74820
      • Recruiting
      • The Chickasaw Nation
      • Contact: Joy Standridge, MPH; Phone Number: 580-310-6463; Email: Joy.Standridge@Chickasaw.Net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ≥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)

Exclusion Criteria:

- Anyone not meeting the aforementioned inclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Communities; 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; 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
No Intervention: Control Communities; Free Tribal Wellness Center membership, Fitbit, and the AYA culturally based mobile walking app

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in systolic blood pressure	Targeted 2.9 mm Hg decrease in systolic blood pressure	Measured before and after the 6 month intervention
Change in body mass index		Measured before and after the 6 month intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food access	USDA Household Food Security Scale (6 Item Short Module) - The sum of affirmative responses provides a household raw score. Food security status of households with raw scores of 0-1 are high or marginally food secure, raw scores of 2-4 are low secure, and raw scores of 5-6 are very low food secure. High raw scores indicate food insecure households.	Measured before and after the 6 month intervention
Diet	ASA24, a self-administered recall system (https://asa24.nci.nih.gov/)	Measured before and after the 6 month intervention
Walking	Fitbit dashboard	Measured during 6 month intervention
Change in self-reported physical activity	International Physical Activity Questionnaire (Short Version) provides separate scores on walking, moderate-intensity, and vigorous-intensity activity. Total scores are calculated by summing the duration (in minutes) and frequency (days) of walking, moderate-intensity, and vigorous-intensity activities. High scores indicate better levels of physical activity.	Measured before and after the 6 month intervention

Collaborators and Investigators

• Sponsor: Oklahoma State University Center for Health Sciences
• Collaborators: Washington State University; The Chickasaw Nation
• Investigators: Principal Investigator: Valarie BB Jernigan, DrPH, MPH, Oklahoma State University Center for Health Sciences; Principal Investigator: Joy Standridge, MPH, The Chickasaw Nation

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2018
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: December 7, 2018
• First Submitted That Met QC Criteria: December 10, 2018
• First Posted (Actual): December 12, 2018

Study Record Updates

• Last Update Posted (Actual): July 1, 2020
• Last Update Submitted That Met QC Criteria: June 29, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Hypertension; Blood Pressure; BMI; Native American; American Indian; CBPR; DASH-Diet; Food Environment; CHEERS
• Additional Relevant MeSH Terms: Body Weight
• Other Study ID Numbers: 7614

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No