Interactive Web Program and Health Coaching for Prehypertensive Adults

Study Overview
=================
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.

Official Title
-----------------
Interactive Web Program and Health Coaching for Prehypertensive Adults

Conditions
-----------------
Weight, Blood Pressure

Intervention / Treatment
-----------------
* Behavioral: BlipHub mobile-web app
* Behavioral: BlipHub mobile-web app + health coaching
* Other: Usual care


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BlipHub mobile-web app<br>Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss. | Behavioral: BlipHub mobile-web app<br>* Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.<br>|
| Experimental: BlipHub mobile-web app + health coaching<br>Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss. | Behavioral: BlipHub mobile-web app + health coaching<br>* Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.<br>|
| Other: Usual care<br>No intervention beyond the participants' personal medical care. | Other: Usual care<br>* No intervention beyond participants' own medical care.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported Lifestyle Change Preparation Behaviors | Participants were asked to self-report on days in the past two weeks in which they engaged in specific behaviors to prepare for or support healthy eating and physical activity (i.e., preparation behaviors). The scale comprised 15 items (e.g., thought about what you might do to try to lose weight) assessed on a 5-point scale (1=none (min), 5=12-14 days (max)). Mean score is reported, with higher scores indicating more frequent preparation behaviors. The scale showed good reliability (alpha=.91). | Baseline, 12 weeks, 24 weeks | 
| Self-reported Self-efficacy for Lifestyle Behaviors | Five items assessed participants' confidence to engage in JNC-recommended healthy behaviors using a 5-item response option (1=not at all confident (min), 5=very confident (max)). Mean score is reported, with higher scores indicating higher self-efficacy. The scale showed good reliability (alpha=.79). | Baseline, 12 weeks, 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lifestyle behavior change