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Chickasaw Healthy Eating Environments Research Study (CHEERS)

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ClinicalTrials.gov Identifier: NCT03774277
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : July 1, 2020
Sponsor:
Collaborators:
The Chickasaw Nation
Washington State University
Information provided by (Responsible Party):
Oklahoma State University Center for Health Sciences

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.

Condition or disease Intervention/treatment Phase
Blood Pressure Body Weight Behavioral: Packed Promise for a Healthy Heart Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chickasaw Healthy Eating Environments Research Study
Actual Study Start Date : July 10, 2018
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Arm Intervention/treatment
Experimental: Intervention Communities
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
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

No Intervention: Control Communities
Free Tribal Wellness Center membership, Fitbit, and the AYA culturally based mobile walking app



Primary Outcome Measures :
  1. Change in systolic blood pressure [ Time Frame: Measured before and after the 6 month intervention ]
    Targeted 2.9 mm Hg decrease in systolic blood pressure

  2. Change in body mass index [ Time Frame: Measured before and after the 6 month intervention ]

Secondary Outcome Measures :
  1. Food access [ Time Frame: Measured before and after the 6 month intervention ]
    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.

  2. Diet [ Time Frame: Measured before and after the 6 month intervention ]
    ASA24, a self-administered recall system (https://asa24.nci.nih.gov/)

  3. Walking [ Time Frame: Measured during 6 month intervention ]
    Fitbit dashboard

  4. Change in self-reported physical activity [ Time Frame: Measured before and after the 6 month intervention ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774277


Contacts
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Contact: Cassandra D Camp, MPH 918-561-1576 cdcamp@okstate.edu
Contact: Charlotte Love, MPH 918-978-5957 charlie.love@okstate.edu

Locations
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United States, Oklahoma
The Chickasaw Nation Recruiting
Ada, Oklahoma, United States, 74820
Contact: Joy Standridge, MPH    580-310-6463    Joy.Standridge@Chickasaw.Net   
Sponsors and Collaborators
Oklahoma State University Center for Health Sciences
The Chickasaw Nation
Washington State University
Investigators
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Principal Investigator: Valarie BB Jernigan, DrPH, MPH Oklahoma State University Center for Health Sciences
Principal Investigator: Joy Standridge, MPH The Chickasaw Nation
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Responsible Party: Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier: NCT03774277    
Other Study ID Numbers: 7614
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oklahoma State University Center for Health Sciences:
Hypertension
Blood Pressure
DASH-Diet
BMI
American Indian
Food Environment
CBPR
CHEERS
Native American
Additional relevant MeSH terms:
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Body Weight