Blood Pressure
Conditions
Brief summary
This is a two phase project. Phase I is an online convenience sample to collect health and preference data for the intervention phase, as well as a partnership with community to co-create an intervention; Phase II. Phase II is an intervention to improve community connection and historical knowledge within Cherokee communities within the Cherokee Nation reservation involving consultation with Cherokee cultural and historical experts.
Detailed description
1. Identify necessary program enhancements to maximize reach and acceptability of the intervention for primary prevention of CVD in Cherokee Nation adults. The new intervention will have a broad reach, and thus, potentially greater public health impact. By building on the well-established and popular intervention, RTR, the goal is to maximize the likelihood that this intervention will be culturally acceptable, logistically feasible, and financially sustainable. 2. Conduct a pilot study (n = 40) to demonstrate acceptability and feasibility of the adapted intervention and research methods. The expectation is that the intervention will be culturally acceptable to participants, and retention and data collection protocols will support feasibility of a larger randomized controlled trial.
Interventions
BEHAVIORALDuyugoda igalenisodi (Starting again the right way)
Participants in the intervention arm will receive training and resources to build community resources and programming
Sponsors
University of Missouri-Columbia
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Citizen of Cherokee tribe
Exclusion criteria
* Under the age of 18
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | Pre; Post (study completion; within 6 months) | Systolic and Diastolic blood pressure measured through millimeters of mercury (mmHG) |
| Weight | Pre;Post | Weight was gathered from participants using a digital scale and measured in pounds. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Keyes Mental Health Continuum, Short Form (Also Known as "Positive Mental Health Scale") | Pre; Post (study completion; within 6 months) | \[1-6\] for a single item, and 14 - 84 for total score for all items summed. Higher scores indicate better outcomes, specifically, flourishing mental health. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMelissa Lewis
University of Missouri School of Medicine
Participant flow
Recruitment details
Recruitment will occur using a publicly available website, CN Facebook page, the RTR Facebook page, and flyers at physical locations, including approved tribal complex buildings, and recruitment at community centers. Interested individuals will be asked to submit an online application using Research Electronic Data Capture (REDCapTM) (however paper copies will be accepted at request of applicant if needed but will be uploaded to REDCapTM), which will then be used to assess eligibility.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 42 years |
| Race (NIH/OMB) American Indian or Alaska Native | 42 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 42 Participants |
| Sex/Gender, Customized Gender Female | 28 Participants |
| Sex/Gender, Customized Gender Male | 12 Participants |
| Sex/Gender, Customized Gender Other | 2 Participants |
| Weight | 227.69 pounds STANDARD_DEVIATION 61.02 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 42 |
| other Total, other adverse events | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 |
Outcome results
None listed