Interactive Web Program and Health Coaching for Prehypertensive Adults

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02637063

Acronym

Prehype

Enrollment

203

Registered

2015-12-22

Start date

2013-11-30

Completion date

2015-03-31

Last updated

2017-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, Weight

Keywords

Lifestyle behavior change

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.

Interventions

BEHAVIORALBlipHub mobile-web app

Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.

BEHAVIORALBlipHub mobile-web app + health coaching

Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.

OTHERUsual care

No intervention beyond participants' own medical care.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Diastolic Blood Pressure	Baseline, 12 weeks, 24 weeks	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.
Heart-healthy Dietary Intake (Number of Fruit/Vegetable Servings, White Meat Servings, Low-fat Dairy Servings)	Baseline, 12 weeks, 24 weeks	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).
Heart-unhealthy Dietary Intake (Self-reported Number of Fat Servings, Red Meat Servings, Dairy Fat Servings)	Baseline, 12 weeks, 24 weeks	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).
Systolic Blood Pressure	Baseline, 12 weeks, 24 weeks	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.
Body Weight	Baseline, 12 weeks, 24 weeks	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.

Secondary

Measure	Time frame	Description
Self-reported Self-efficacy for Lifestyle Behaviors	Baseline, 12 weeks, 24 weeks	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).
Self-reported Lifestyle Change Preparation Behaviors	Baseline, 12 weeks, 24 weeks	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).

Countries

United States

Participant flow

Participants by arm

Arm	Count
BlipHub Mobile-web App Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss. BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.	67
BlipHub Mobile-web App + Health Coaching Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss. BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.	68
Usual Care No intervention beyond the participants' personal medical care. Usual care: No intervention beyond participants' own medical care.	68
Total	203

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Lost to Follow-up	3	2	3
Overall Study	Withdrawal by Subject	2	2	3

Baseline characteristics

Characteristic	BlipHub Mobile-web App	BlipHub Mobile-web App + Health Coaching	Usual Care	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	67 Participants	68 Participants	68 Participants	203 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants	9 Participants	6 Participants	19 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	63 Participants	59 Participants	62 Participants	184 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	2 Participants	1 Participants	3 Participants
Race (NIH/OMB) Asian	3 Participants	2 Participants	2 Participants	7 Participants
Race (NIH/OMB) Black or African American	12 Participants	11 Participants	12 Participants	35 Participants
Race (NIH/OMB) More than one race	3 Participants	1 Participants	3 Participants	7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants	4 Participants	3 Participants	10 Participants
Race (NIH/OMB) White	46 Participants	48 Participants	47 Participants	141 Participants
Sex: Female, Male Female	41 Participants	43 Participants	45 Participants	129 Participants
Sex: Female, Male Male	26 Participants	25 Participants	23 Participants	74 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	11 / 67	13 / 68	14 / 68
serious Total, serious adverse events	0 / 67	0 / 68	0 / 68

Outcome results

Primary

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.