Trial Outcomes & Findings for Interactive Web Program and Health Coaching for Prehypertensive Adults (NCT NCT02637063)
NCT ID: NCT02637063
Last Updated: 2017-03-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
203 participants
Primary outcome timeframe
Baseline, 12 weeks, 24 weeks
Results posted on
2017-03-15
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
Usual Care
No intervention beyond the participants' personal medical care.
Usual care: No intervention beyond participants' own medical care.
|
|---|---|---|---|
|
Overall Study
STARTED
|
67
|
68
|
68
|
|
Overall Study
COMPLETED
|
62
|
64
|
62
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
6
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
Usual Care
No intervention beyond the participants' personal medical care.
Usual care: No intervention beyond participants' own medical care.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
3
|
Baseline Characteristics
Interactive Web Program and Health Coaching for Prehypertensive Adults
Baseline characteristics by cohort
| Measure |
BlipHub Mobile-web App
n=67 Participants
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.
|
BlipHub Mobile-web App + Health Coaching
n=68 Participants
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.
|
Usual Care
n=68 Participants
No intervention beyond the participants' personal medical care.
Usual care: No intervention beyond participants' own medical care.
|
Total
n=203 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
67 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
203 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
129 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
184 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
141 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeks, 24 weeksBlood 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.
Outcome measures
| Measure |
BlipHub Mobile-web App
n=67 Participants
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.
|
BlipHub Mobile-web App + Health Coaching
n=68 Participants
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.
|
Usual Care
n=68 Participants
No intervention beyond the participants' personal medical care.
Usual care: No intervention beyond participants' own medical care.
|
|---|---|---|---|
|
Systolic Blood Pressure
Baseline
|
128.99 mm Hg
Standard Deviation 12.77
|
131.4 mm Hg
Standard Deviation 12.80
|
131.21 mm Hg
Standard Deviation 12.82
|
|
Systolic Blood Pressure
12-week post-test
|
127.45 mm Hg
Standard Deviation 13.67
|
130.40 mm Hg
Standard Deviation 14.40
|
130.00 mm Hg
Standard Deviation 11.96
|
|
Systolic Blood Pressure
24-week follow-up
|
127.50 mm Hg
Standard Deviation 12.68
|
127.81 mm Hg
Standard Deviation 12.31
|
128.90 mm Hg
Standard Deviation 12.49
|
PRIMARY outcome
Timeframe: Baseline, 12 weeks, 24 weeksBlood 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.
Outcome measures
| Measure |
BlipHub Mobile-web App
n=67 Participants
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.
|
BlipHub Mobile-web App + Health Coaching
n=68 Participants
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.
|
Usual Care
n=68 Participants
No intervention beyond the participants' personal medical care.
Usual care: No intervention beyond participants' own medical care.
|
|---|---|---|---|
|
Diastolic Blood Pressure
Baseline
|
76.95 mm Hg
Standard Deviation 11.03
|
80.48 mm Hg
Standard Deviation 10.10
|
77.83 mm Hg
Standard Deviation 10.46
|
|
Diastolic Blood Pressure
12-week post-test
|
75.78 mm Hg
Standard Deviation 10.42
|
76.80 mm Hg
Standard Deviation 11.65
|
77.55 mm Hg
Standard Deviation 11.15
|
|
Diastolic Blood Pressure
24-week follow-up
|
77.31 mm Hg
Standard Deviation 11.60
|
78.11 mm Hg
Standard Deviation 9.89
|
78.13 mm Hg
Standard Deviation 9.46
|
PRIMARY outcome
Timeframe: Baseline, 12 weeks, 24 weeksBody 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.
Outcome measures
| Measure |
BlipHub Mobile-web App
n=67 Participants
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.
|
BlipHub Mobile-web App + Health Coaching
n=68 Participants
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.
|
Usual Care
n=68 Participants
No intervention beyond the participants' personal medical care.
Usual care: No intervention beyond participants' own medical care.
|
|---|---|---|---|
|
Body Weight
Baseline
|
187.21 Pounds
Standard Deviation 49.67
|
196.65 Pounds
Standard Deviation 37.98
|
187.60 Pounds
Standard Deviation 48.76
|
|
Body Weight
12-week post-test
|
187.61 Pounds
Standard Deviation 49.64
|
194.58 Pounds
Standard Deviation 38.60
|
194.05 Pounds
Standard Deviation 47.14
|
|
Body Weight
24-week follow-up
|
187.67 Pounds
Standard Deviation 50.57
|
194.77 Pounds
Standard Deviation 39.00
|
196.60 Pounds
Standard Deviation 50.98
|
PRIMARY outcome
Timeframe: Baseline, 12 weeks, 24 weeksParticipants 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).
Outcome measures
| Measure |
BlipHub Mobile-web App
n=67 Participants
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.
|
BlipHub Mobile-web App + Health Coaching
n=68 Participants
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.
|
Usual Care
n=68 Participants
No intervention beyond the participants' personal medical care.
Usual care: No intervention beyond participants' own medical care.
|
|---|---|---|---|
|
Heart-healthy Dietary Intake (Number of Fruit/Vegetable Servings, White Meat Servings, Low-fat Dairy Servings)
Baseline
|
5.98 Servings
Standard Deviation 4.47
|
6.10 Servings
Standard Deviation 4.74
|
5.85 Servings
Standard Deviation 4.28
|
|
Heart-healthy Dietary Intake (Number of Fruit/Vegetable Servings, White Meat Servings, Low-fat Dairy Servings)
12-week post-test
|
5.22 Servings
Standard Deviation 3.71
|
6.22 Servings
Standard Deviation 4.48
|
4.87 Servings
Standard Deviation 3.93
|
|
Heart-healthy Dietary Intake (Number of Fruit/Vegetable Servings, White Meat Servings, Low-fat Dairy Servings)
24-week follow-up
|
5.60 Servings
Standard Deviation 4.32
|
6.03 Servings
Standard Deviation 3.92
|
5.53 Servings
Standard Deviation 4.25
|
PRIMARY outcome
Timeframe: Baseline, 12 weeks, 24 weeksParticipants 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).
Outcome measures
| Measure |
BlipHub Mobile-web App
n=67 Participants
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.
|
BlipHub Mobile-web App + Health Coaching
n=68 Participants
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.
|
Usual Care
n=68 Participants
No intervention beyond the participants' personal medical care.
Usual care: No intervention beyond participants' own medical care.
|
|---|---|---|---|
|
Heart-unhealthy Dietary Intake (Self-reported Number of Fat Servings, Red Meat Servings, Dairy Fat Servings)
Baseline
|
4.94 Servings
Standard Deviation 4.72
|
4.54 Servings
Standard Deviation 3.66
|
5.15 Servings
Standard Deviation 3.62
|
|
Heart-unhealthy Dietary Intake (Self-reported Number of Fat Servings, Red Meat Servings, Dairy Fat Servings)
12-week post-test
|
4.33 Servings
Standard Deviation 3.82
|
3.70 Servings
Standard Deviation 2.61
|
4.12 Servings
Standard Deviation 3.13
|
|
Heart-unhealthy Dietary Intake (Self-reported Number of Fat Servings, Red Meat Servings, Dairy Fat Servings)
24-week follow-up
|
4.17 Servings
Standard Deviation 3.11
|
3.77 Servings
Standard Deviation 3.80
|
4.61 Servings
Standard Deviation 3.44
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 24 weeksParticipants 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).
Outcome measures
| Measure |
BlipHub Mobile-web App
n=67 Participants
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.
|
BlipHub Mobile-web App + Health Coaching
n=68 Participants
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.
|
Usual Care
n=68 Participants
No intervention beyond the participants' personal medical care.
Usual care: No intervention beyond participants' own medical care.
|
|---|---|---|---|
|
Self-reported Lifestyle Change Preparation Behaviors
Baseline
|
2.70 units on a Likert scale
Standard Deviation 0.89
|
2.52 units on a Likert scale
Standard Deviation 0.74
|
2.48 units on a Likert scale
Standard Deviation 0.88
|
|
Self-reported Lifestyle Change Preparation Behaviors
12-week post-test
|
2.78 units on a Likert scale
Standard Deviation 0.95
|
2.88 units on a Likert scale
Standard Deviation 0.84
|
2.48 units on a Likert scale
Standard Deviation 0.88
|
|
Self-reported Lifestyle Change Preparation Behaviors
24-week follow-up
|
2.67 units on a Likert scale
Standard Deviation 0.90
|
2.70 units on a Likert scale
Standard Deviation 0.85
|
2.45 units on a Likert scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 24 weeksFive 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).
Outcome measures
| Measure |
BlipHub Mobile-web App
n=67 Participants
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.
|
BlipHub Mobile-web App + Health Coaching
n=68 Participants
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.
|
Usual Care
n=68 Participants
No intervention beyond the participants' personal medical care.
Usual care: No intervention beyond participants' own medical care.
|
|---|---|---|---|
|
Self-reported Self-efficacy for Lifestyle Behaviors
Baseline
|
4.06 units on a Likert-type scale
Standard Deviation 0.60
|
4.10 units on a Likert-type scale
Standard Deviation 0.61
|
3.97 units on a Likert-type scale
Standard Deviation 0.73
|
|
Self-reported Self-efficacy for Lifestyle Behaviors
12-week post-test
|
3.67 units on a Likert-type scale
Standard Deviation 0.78
|
3.87 units on a Likert-type scale
Standard Deviation 0.60
|
3.65 units on a Likert-type scale
Standard Deviation 0.69
|
|
Self-reported Self-efficacy for Lifestyle Behaviors
24-week follow-up
|
3.71 units on a Likert-type scale
Standard Deviation 0.88
|
3.83 units on a Likert-type scale
Standard Deviation 0.61
|
3.70 units on a Likert-type scale
Standard Deviation 0.64
|
Adverse Events
BlipHub Mobile-web App
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
BlipHub Mobile-web App + Health Coaching
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BlipHub Mobile-web App
n=67 participants at risk
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.
|
BlipHub Mobile-web App + Health Coaching
n=68 participants at risk
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.
|
Usual Care
n=68 participants at risk
No intervention beyond the participants' personal medical care.
Usual care: No intervention beyond participants' own medical care.
|
|---|---|---|---|
|
Vascular disorders
Elevated BP (SBP 160+ or DBP 100+)
|
16.4%
11/67 • Number of events 11 • 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.
|
19.1%
13/68 • Number of events 13 • 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.
|
20.6%
14/68 • Number of events 14 • 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.
|
Additional Information
Amelia J Birney (PI), Director of Research
Oregon Center for Applied Science
Phone: 541-342-7227
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place