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Interactive Web Program and Health Coaching for Prehypertensive Adults

O

Oregon Center for Applied Science

Status

Completed

Conditions

Blood Pressure
Weight

Treatments

Other: Usual care
Behavioral: BlipHub mobile-web app
Behavioral: BlipHub mobile-web app + health coaching

Study type

Interventional

Funder types

Industry
NIH

Identifiers

NCT02637063
R44HL095229 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

203 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

203 participants in 3 patient groups

BlipHub mobile-web app
Experimental group
Description:
Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.
Treatment:
Behavioral: BlipHub mobile-web app
BlipHub mobile-web app + health coaching
Experimental group
Description:
Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.
Treatment:
Behavioral: BlipHub mobile-web app + health coaching
Usual care
Other group
Description:
No intervention beyond the participants' personal medical care.
Treatment:
Other: Usual care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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