Clinical Trials Directory

Trials / Completed

CompletedNCT03774277

Chickasaw Healthy Eating Environments Research Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
262 (actual)
Sponsor
Oklahoma State University Center for Health Sciences · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPacked Promise for a Healthy HeartVoucher 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

Timeline

Start date
2018-07-10
Primary completion
2020-12-24
Completion
2020-12-24
First posted
2018-12-12
Last updated
2024-08-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03774277. Inclusion in this directory is not an endorsement.