Interactive Web Program and Health Coaching for Prehypertensive Adults
Prehype
1 other identifier
interventional
203
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 9, 2015
CompletedFirst Posted
Study publicly available on registry
December 22, 2015
CompletedResults Posted
Study results publicly available
March 15, 2017
CompletedMarch 15, 2017
January 1, 2017
1.3 years
November 9, 2015
October 12, 2016
January 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Systolic Blood Pressure
Blood pressure measurements were taken by participants using a validated, WIFI-enabled blood pressure cuff manufactured by BlipCare and provided to study subjects prior to the baseline assessment. Measurements were automatically uploaded over a WIFI connection to the BlipHub app and study outcomes database. Participants followed a standardized measurement protocol based on the American Heart Association protocol for home blood pressure measurement, involving three consecutive measurements, taken one minute apart after a five-minute seated resting period. Measurements were not observed.
Baseline, 12 weeks, 24 weeks
Diastolic Blood Pressure
Blood pressure measurements were taken by participants using a validated, WIFI-enabled blood pressure cuff manufactured by BlipCare and provided to study subjects prior to the baseline assessment. Measurements were automatically uploaded over a WIFI connection to the BlipHub app and study outcomes database. Participants followed a standardized measurement protocol based on the American Heart Association protocol for home blood pressure measurement, involving three consecutive measurements, taken one minute apart after a five-minute seated resting period. Measurements were not observed.
Baseline, 12 weeks, 24 weeks
Body Weight
Body weight measurements were taken by participants using a validated, WIFI-enabled weight scale manufactured by BlipCare and provided to study subjects prior to the baseline assessment. Measurements were automatically uploaded over a WIFI connection to the BlipHub app and study outcomes database. Participants were instructed to take weight measurements at the same time of day each time, preferably first thing in the morning after using the bathroom and before eating or drinking. The weight measurement taken on the date and time closest to the completion date and time of each individual's online survey for that assessment point was analyzed. If no measurements were available within two weeks on either side of that date, weight measurements were considered missing for that assessment period.
Baseline, 12 weeks, 24 weeks
Heart-healthy Dietary Intake (Number of Fruit/Vegetable Servings, White Meat Servings, Low-fat Dairy Servings)
Participants were asked about their diet during the past month, using DASH-diet related items adapted from several validated food frequency questionnaires. Participants reported on servings consumed (e.g., never, 1-3 times last month, up to 5 or more times a day) of the following foods: fruits, vegetables, dairy, fats and meat. Number of servings was computed for heart-healthy foods (fruits, vegetables and lean meats).
Baseline, 12 weeks, 24 weeks
Heart-unhealthy Dietary Intake (Self-reported Number of Fat Servings, Red Meat Servings, Dairy Fat Servings)
Participants were asked about their diet during the past month, using DASH-diet related items adapted from several validated food frequency questionnaires. Participants reported on servings consumed (e.g., never, 1-3 times last month, up to 5 or more times a day) of the following foods: fruits, vegetables, dairy, fats and meat. Number of servings was computed for heart-unhealthy foods (red, processed and high-fat prepared meats).
Baseline, 12 weeks, 24 weeks
Secondary Outcomes (2)
Self-reported Lifestyle Change Preparation Behaviors
Baseline, 12 weeks, 24 weeks
Self-reported Self-efficacy for Lifestyle Behaviors
Baseline, 12 weeks, 24 weeks
Study Arms (3)
BlipHub mobile-web app
EXPERIMENTALMobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.
BlipHub mobile-web app + health coaching
EXPERIMENTALTelephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.
Usual care
OTHERNo intervention beyond the participants' personal medical care.
Interventions
Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.
Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ORCAS
Eugene, Oregon, 97401, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Amelia J Birney (PI), Director of Research
- Organization
- Oregon Center for Applied Science
Study Officials
- PRINCIPAL INVESTIGATOR
Amelia J. Birney, MPH, MCHES
Oregon Center for Applied Science, Inc.
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2015
First Posted
December 22, 2015
Study Start
November 1, 2013
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
March 15, 2017
Results First Posted
March 15, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share