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
|Condition or disease||Intervention/treatment||Phase|
|Blood Pressure Body Weight||Behavioral: Packed Promise for a Healthy Heart||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- Change in body mass index [ Time Frame: Measured before and after the 6 month intervention ]
- 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.
- Diet [ Time Frame: Measured before and after the 6 month intervention ]ASA24, a self-administered recall system (https://asa24.nci.nih.gov/)
- Walking [ Time Frame: Measured during 6 month intervention ]Fitbit dashboard
- 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.
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
|Contact: Cassandra D Camp, MPHemail@example.com|
|Contact: Charlotte Love, MPHfirstname.lastname@example.org|
|United States, Oklahoma|
|The Chickasaw Nation||Recruiting|
|Ada, Oklahoma, United States, 74820|
|Contact: Joy Standridge, MPH 580-310-6463 Joy.Standridge@Chickasaw.Net|
|Principal Investigator:||Valarie BB Jernigan, DrPH, MPH||Oklahoma State University Center for Health Sciences|
|Principal Investigator:||Joy Standridge, MPH||The Chickasaw Nation|