Blood Pressure Clinical Trial
— PrehypeOfficial title:
Interactive Web Program and Health Coaching for Prehypertensive Adults
This project will develop and evaluate an interactive blood pressure self-management program
for adults with prehypertension. The program will target blood pressure self-monitoring and
the five proven lifestyle modifications recommended by JNC-7: weight reduction, the Dietary
Approaches to Stop Hypertension (DASH) diet, sodium reduction, physical activity, and
alcohol consumption.
The multi-modal program uses a combination of brief motivational health coaching, periodic
engagement emails, and a robust interactive website to motivate people to take charge of
their blood pressure management before they require medication. All program components were
designed to conform to the underlying principles of motivational interviewing. Key program
components include the use of email and Web-based social networking, personal stories, and a
brief motivational coaching session to engage participants and encourage intrinsically
motivated behavior changes. Self-assessment and tracking tools are combined with educational
content to help participants align their daily lifestyle choices with their personal goals.
The Phase I prototype program promoted moderate physical activity and eating fruits and
vegetables as part of the DASH diet. Results from the within-group (n = 39) evaluation
showed moderate-to-large effect sizes for pre-to-post change in motivation, preparation
behavior, self-efficacy, attitudes, and knowledge, and a small significant increase in
physical activity. Participants gave the online program high ratings on satisfaction and
usability, and reported improvements in confidence, readiness, clarity, change strategies,
and interest in visiting the Website as a result of the coaching session.
The fully developed Phase II product will be evaluated in a large randomized trial (N = 450)
with a 3-month intensive intervention, a 3-month maintenance intervention, and a 3-month
follow-up period. The Phase II trial is expected to show reductions in blood pressure and
improvements in JNC-recommended health behaviors. These changes in the outcome measures are
expected to be mediated by changes in knowledge, attitudes, self-efficacy, behavioral
intention, motivation, and patient activation.
Status | Active, not recruiting |
Enrollment | 201 |
Est. completion date | December 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria - Blood pressure in the JNC-7-defined prehypertension range (SBP 120-139 and/or DBP 80-89) - Must be at least 18 years old - Must be employed at least part time - Must have access to the internet through a WIFI connection in a place where subject was willing to take BP and weight measurements - Must be the only participant per household in the study Exclusion Criteria - Female subjects must not be pregnant or planning to get pregnant over the course of study - Must not have experienced a stroke, heart attack, or heart disease diagnosis in the prior six months - Must not be taking antihypertensive medications for any reason |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | ORCAS | Eugene | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon Center for Applied Science, Inc. | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in systolic blood pressure | Baseline, 4 weeks, 12 weeks, 24 weeks | No | |
Primary | Change from baseline in diastolic blood pressure | Baseline, 4 weeks, 12 weeks, 24 weeks | No | |
Primary | Change from baseline in body weight | Baseline, 4 weeks, 12 weeks, 24 weeks | No | |
Primary | Change from baseline in the Weight Control Strategies Scale | Baseline, 4 weeks, 12 weeks, 24 weeks | No | |
Primary | Change from baseline in self-reported physical activity using the International Physical Activity Questionnaire | Baseline, 4 weeks, 12 weeks, 24 weeks | No | |
Primary | Change from baseline in heart-healthy dietary intake (number of fruit/vegetable servings, white meat servings, low-fat dairy servings) | Baseline, 4 weeks, 12 weeks, 24 weeks | No | |
Primary | Change from baseline in heart-unhealthy dietary intake (self-reported number of fat servings, red meat servings, dairy fat servings) | Baseline, 4 weeks, 12 weeks, 24 weeks | No | |
Secondary | Change from baseline in self-reported lifestyle change preparation behavior questionnaire | Baseline, 4 weeks, 12 weeks, 24 weeks | No | |
Secondary | Change from baseline in self-reported self-efficacy for lifestyle behavior questionnaire | Baseline, 4 weeks, 12 weeks, 24 weeks | No | |
Secondary | Change from baseline in workplace productivity based on the Workplace Outcomes Suite | Baseline, 4 weeks, 12 weeks, 24 weeks | No |
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