Chickasaw Healthy Eating Environments Research Study (CHEERS)
Primary Purpose
Blood Pressure, Body Weight
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Packed Promise for a Healthy Heart
Sponsored by
About this trial
This is an interventional treatment trial for Blood Pressure focused on measuring Hypertension, Blood Pressure, DASH-Diet, BMI, American Indian, Food Environment, CBPR, CHEERS, Native American
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
Sites / Locations
- The Chickasaw NationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Communities
Control Communities
Arm Description
Packed Promise for a Healthy Heart intervention, free Tribal Wellness Center membership, a Fitbit, and the AYA culturally based mobile walking app.
Free Tribal Wellness Center membership, Fitbit, and the AYA culturally based mobile walking app
Outcomes
Primary Outcome Measures
Change in systolic blood pressure
Targeted 2.9 mm Hg decrease in systolic blood pressure
Change in body mass index
Secondary Outcome Measures
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.
Diet
ASA24, a self-administered recall system (https://asa24.nci.nih.gov/)
Walking
Fitbit dashboard
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.
Full Information
NCT ID
NCT03774277
First Posted
December 7, 2018
Last Updated
June 29, 2020
Sponsor
Oklahoma State University Center for Health Sciences
Collaborators
The Chickasaw Nation, Washington State University
1. Study Identification
Unique Protocol Identification Number
NCT03774277
Brief Title
Chickasaw Healthy Eating Environments Research Study
Acronym
CHEERS
Official Title
Chickasaw Healthy Eating Environments Research Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 10, 2018 (Actual)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
February 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oklahoma State University Center for Health Sciences
Collaborators
The Chickasaw Nation, Washington State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Body Weight
Keywords
Hypertension, Blood Pressure, DASH-Diet, BMI, American Indian, Food Environment, CBPR, CHEERS, Native American
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Communities
Arm Type
Experimental
Arm Description
Packed Promise for a Healthy Heart intervention, free Tribal Wellness Center membership, a Fitbit, and the AYA culturally based mobile walking app.
Arm Title
Control Communities
Arm Type
No Intervention
Arm Description
Free Tribal Wellness Center membership, Fitbit, and the AYA culturally based mobile walking app
Intervention Type
Behavioral
Intervention Name(s)
Packed Promise for a Healthy Heart
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in systolic blood pressure
Description
Targeted 2.9 mm Hg decrease in systolic blood pressure
Time Frame
Measured before and after the 6 month intervention
Title
Change in body mass index
Time Frame
Measured before and after the 6 month intervention
Secondary Outcome Measure Information:
Title
Food access
Description
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
Title
Diet
Description
ASA24, a self-administered recall system (https://asa24.nci.nih.gov/)
Time Frame
Measured before and after the 6 month intervention
Title
Walking
Description
Fitbit dashboard
Time Frame
Measured during 6 month intervention
Title
Change in self-reported physical activity
Description
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.
Time Frame
Measured before and after the 6 month intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cassandra D Camp, MPH
Phone
918-561-1576
Email
cdcamp@okstate.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte Love, MPH
Phone
918-978-5957
Email
charlie.love@okstate.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valarie BB Jernigan, DrPH, MPH
Organizational Affiliation
Oklahoma State University Center for Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joy Standridge, MPH
Organizational Affiliation
The Chickasaw Nation
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chickasaw Nation
City
Ada
State/Province
Oklahoma
ZIP/Postal Code
74820
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joy Standridge, MPH
Phone
580-310-6463
Email
Joy.Standridge@Chickasaw.Net
12. IPD Sharing Statement
Plan to Share IPD
No
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Chickasaw Healthy Eating Environments Research Study
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