Blood PressureCHEERSNCT03774277
Chickasaw Healthy Eating Environments Research Study
A study testing Packed Promise for a Healthy Heart in people with Blood Pressure and Body Weight, run by Oklahoma State University Center for Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure, Body Weight
- What is being tested?
- Packed Promise for a Healthy Heart
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2018to 24 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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)
Who cannot join
- Anyone not meeting the aforementioned inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Blood Pressure, Body Weight
- Being tested
- Packed Promise for a Healthy Heart
- Keywords
- Hypertension, Blood Pressure, DASH-Diet, BMI, American Indian, Food Environment, CBPR, CHEERS, Native American
- Medical subject headings
- Body Weight, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Packed Promise for a Healthy HeartBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Communities | Experimental | Packed Promise for a Healthy Heart intervention, free Tribal Wellness Center membership, a Fitbit, and the AYA culturally based mobile walking app. Receives: Behavioral: Packed Promise for a Healthy Heart |
| Control Communities | No intervention | Free Tribal Wellness Center membership, Fitbit, and the AYA culturally based mobile walking app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure
Targeted 2.9 mm Hg decrease in systolic blood pressure
Measured: Measured before and after the 6 month intervention
Secondary outcomes (3)
Food security
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: Measured before and after the 6 month intervention
Diet
ASA24, a self-administered recall system (https://asa24.nci.nih.gov/)
Measured: Measured before and after the 6 month intervention
Change in body mass index
Using measured height and weight
Measured: Measured before and after the 6 month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start10 Jul 2018
- Primary completion24 Dec 2020
- Study completion24 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University Center for Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The Chickasaw Nation, Washington State University
- Responsible party
- Sponsor
- Investigators
- Valarie BB Jernigan, DrPH, MPH, Principal investigator, Oklahoma State University Center for Health SciencesJoy Standridge, MPH, Principal investigator, The Chickasaw Nation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774277
- Sponsor's protocol ID
- 7614
- Acronym
- CHEERS
- Status last verified
- Aug 2024
- First submitted
- 7 Dec 2018
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chickasaw Healthy Eating Environments Research Study
- ClinicalTrials.gov ID
- NCT03774277
- Acronym / sponsor ID
- CHEERS / 7614
- Conditions
- Blood Pressure, Body Weight
- Keywords
- Hypertension, Blood Pressure, DASH-Diet, BMI, American Indian, Food Environment, CBPR, CHEERS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Oklahoma State University Center for Health SciencesUniversity, hospital or other
- Collaborators
- The Chickasaw Nation, Washington State University
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 24 Dec 2020 (actual)
- Study completion
- 24 Dec 2020 (actual)
- First posted
- 12 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Communities | Experimental | Behavioral: Packed Promise for a Healthy HeartPacked Promise for a Healthy Heart intervention, free Tribal Wellness Center membership, a Fitbit, and the AYA culturally based mobile walking app. |
| Control Communities | No intervention | –Free Tribal Wellness Center membership, Fitbit, and the AYA culturally based mobile walking app |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥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
Key exclusion criteria (1 listed)
- Anyone not meeting the aforementioned inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Packed Promise for a Healthy HeartVoucher 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 | Behavioural | Intervention Communities |
Primary outcome
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
3 secondary outcomes
Food security
Time frame: Measured before and after the 6 month intervention
Diet
Time frame: Measured before and after the 6 month intervention
Change in body mass index
Time frame: Measured before and after the 6 month intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valarie BB Jernigan, DrPH, MPH principal investigator
Oklahoma State University Center for Health Sciences
Joy Standridge, MPH principal investigator
The Chickasaw Nation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Packed Promise for a Healthy Heart in people with Blood Pressure and Body Weight, run by Oklahoma State University Center for Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic blood pressure (time frame: Measured before and after the 6 month intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.