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| ID | Type | Description | Link |
|---|---|---|---|
| R44HL095229 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BlipHub mobile-web app | Experimental | Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss. |
|
| BlipHub mobile-web app + health coaching | Experimental | Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss. |
|
| Usual care | Other | No intervention beyond the participants' personal medical care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BlipHub mobile-web app | Behavioral | Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss. |
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| 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 |
| 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). |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Amelia J. Birney, MPH, MCHES | Oregon Center for Applied Science, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ORCAS | Eugene | Oregon | 97401 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Usual Care | No intervention beyond the participants' personal medical care. Usual care: No intervention beyond participants' own medical care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | BlipHub Mobile-web App + Health Coaching |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | mm Hg | Baseline, 12 weeks, 24 weeks |
|
Adverse event monitoring lasted for 30 months, beginning with screening on 07/22/2013 and ending when the last participant completed the last blood pressure assessment on 3/25/2015.
Blood pressure measurements (self-reported during screening and WIFI-transmitted for assessments) were monitored throughout data collection. Subjects with readings of systolic BP 160+ and/or diastolic BP 100+ were emailed with the recommendation to have their blood pressure checked by licensed healthcare professional.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated BP (SBP 160+ or DBP 100+) | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amelia J Birney (PI), Director of Research | Oregon Center for Applied Science | 541-342-7227 | 541 | abirney@orcasinc.com |
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| ID | Term |
|---|---|
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| BlipHub mobile-web app + health coaching | Behavioral | Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss. |
|
| Usual care | Other | No intervention beyond participants' own medical care. |
|
| 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 |
| 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 |
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. |
| BG002 | Usual Care | No intervention beyond the participants' personal medical care. Usual care: No intervention beyond participants' own medical care. |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | 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. |
| OG002 | Usual Care | No intervention beyond the participants' personal medical care. Usual care: No intervention beyond participants' own medical care. |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | mm Hg | Baseline, 12 weeks, 24 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Pounds | Baseline, 12 weeks, 24 weeks |
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | Servings | Baseline, 12 weeks, 24 weeks |
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | Servings | Baseline, 12 weeks, 24 weeks |
|
|
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| Secondary | 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). | Posted | Mean | Standard Deviation | units on a Likert scale | Baseline, 12 weeks, 24 weeks |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | units on a Likert-type scale | Baseline, 12 weeks, 24 weeks |
|
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|
| 0 |
| 67 |
| 11 |
| 67 |
| EG001 | 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. | 0 | 68 | 13 | 68 |
| EG002 | Usual Care | No intervention beyond the participants' personal medical care. Usual care: No intervention beyond participants' own medical care. | 0 | 68 | 14 | 68 |
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| 24-week follow-up |
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| 24-week follow-up |
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| 24-week follow-up |
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| 24-week follow-up |
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| 24-week follow-up |
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| 24-week follow-up |
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