Clinical trial NCT03774277: Chickasaw Healthy Eating Environments Research Study
Official title: Chickasaw Healthy Eating Environments Research Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Body Weight
Keywords: Hypertension
Blood Pressure
DASH-Diet
BMI
American Indian
Food Environment
CBPR
CHEERS
Native American
Lead sponsor: Oklahoma State University Center for Health Sciences
Sponsor class: OTHER
Collaborators: name: The Chickasaw Nation
name: Washington State University
First posted: 2018-12-12
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in systolic blood pressure
timeFrame: Measured before and after the 6 month intervention
Secondary outcomes:
measure: Food security
timeFrame: Measured before and after the 6 month intervention
measure: Diet
timeFrame: Measured before and after the 6 month intervention
measure: Change in body mass index
timeFrame: Measured before and after the 6 month intervention
Other outcomes:
Locations:
city: Ada
country: United States
facility: The Chickasaw Nation
state: Oklahoma
Study officials:
affiliation: Oklahoma State University Center for Health Sciences
name: Valarie BB Jernigan, DrPH, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: The Chickasaw Nation
name: Joy Standridge, MPH
role: PRINCIPAL_INVESTIGATOR
References: