Chickasaw Healthy Eating Environments Research Study

Blood Pressure Clinical Trial

— CHEERS  

Official title:

Chickasaw Healthy Eating Environments Research Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03774277
• Other study ID #: 7614
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2018
• Est. completion date: February 2021

Study information

• Verified date: June 2020
• Source: Oklahoma State University Center for Health Sciences
• Contact: Cassandra D Camp, MPH
• Phone: 918-561-1576
• Email: cdcamp[@]okstate.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: February 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Body Weight

Intervention

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

Locations

Country	Name	City	State
United States	The Chickasaw Nation	Ada	Oklahoma

Sponsors (3)

Lead Sponsor	Collaborator
Oklahoma State University Center for Health Sciences	The Chickasaw Nation, Washington State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in systolic blood pressure	Targeted 2.9 mm Hg decrease in systolic blood pressure	Measured before and after the 6 month intervention
Primary	Change in body mass index		Measured before and after the 6 month intervention
Secondary	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
Secondary	Diet	ASA24, a self-administered recall system (https://asa24.nci.nih.gov/)	Measured before and after the 6 month intervention
Secondary	Walking	Fitbit dashboard	Measured during 6 month intervention
Secondary	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