Clinical trial NCT02637063: Interactive Web Program and Health Coaching for Prehypertensive Adults
Official title: Interactive Web Program and Health Coaching for Prehypertensive Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight
Blood Pressure
Keywords: Lifestyle behavior change
Lead sponsor: Oregon Center for Applied Science, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2015-12-22
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Approximately a third (31%) of adult Americans are prehypertensive (SBP 120-139 and/or DBP 80-89). Health care providers struggle to provide effective support for blood-pressure-lowering behavior changes, while patients continue to progress to full hypertension and the use of antihypertensive medications. Insurers and providers with access to electronic medical records, claims, and other medical data are in a unique position to identify prehypertensive adults and target them with a blood pressure self-management program. Preventing or delaying hypertension should reduce mid-term costs of antihypertensive medications and, more importantly, long-term costs of care for heart disease and stroke.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Diastolic Blood Pressure
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Body Weight
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Heart-healthy Dietary Intake (Number of Fruit/Vegetable Servings, White Meat Servings, Low-fat Dairy Servings)
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Heart-unhealthy Dietary Intake (Self-reported Number of Fat Servings, Red Meat Servings, Dairy Fat Servings)
timeFrame: Baseline, 12 weeks, 24 weeks
Secondary outcomes:
measure: Self-reported Lifestyle Change Preparation Behaviors
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Self-reported Self-efficacy for Lifestyle Behaviors
timeFrame: Baseline, 12 weeks, 24 weeks
Other outcomes:
Locations:
city: Eugene
country: United States
facility: ORCAS
state: Oregon
Study officials:
affiliation: Oregon Center for Applied Science, Inc.
name: Amelia J. Birney, MPH, MCHES
role: PRINCIPAL_INVESTIGATOR
References: