An interventional study of Packed Promise for a Healthy Heart in Blood Pressure and Body Weight, sponsored by Oklahoma State University Center for Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-09.
Sponsored by Oklahoma State University Center for Health Sciences · Not applicable, Interventional, and Treatment
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.
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.
1,238 studies on the registry are indexed under Body Weight; 136 are open to participants now.
This study's enrollment of 262 is above the median of 66 across 959 interventional studies indexed under Body Weight.
Browse Body Weight studies →Oklahoma State University Center for Health Sciences is the lead sponsor of 35 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
- Anyone not meeting the aforementioned inclusion criteria
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
Free Tribal Wellness Center membership, Fitbit, and the AYA culturally based mobile walking app
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
Change in systolic blood pressure
Targeted 2.9 mm Hg decrease in systolic blood pressure
Time frame: Measured before and after the 6 month intervention
Food security
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.
Time frame: Measured before and after the 6 month intervention
Diet
ASA24, a self-administered recall system (https://asa24.nci.nih.gov/)
Time frame: Measured before and after the 6 month intervention
Change in body mass index
Using measured height and weight
Time frame: Measured before and after the 6 month intervention
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Oklahoma State University Center for Health Sciences