Trial Outcomes & Findings for MOBILE Intervention in College Students With Elevated Blood Pressure (NCT NCT05956925)
NCT ID: NCT05956925
Last Updated: 2024-08-19
Results Overview
BP level (systolic and diastolic BP) was taken using the Withings Wireless BP cuff by the participant in the intervention group.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
Average value from 28 days
Results posted on
2024-08-19
Participant Flow
Participants who had HTN stage II (SBP \>140 mm Hg or DBP \>90 mm Hg) during screening and enrollment, but did not provide a health care provider note were not assigned to a group.
Participant milestones
| Measure |
Control
Following the educational session, the control group participants' BP, ASA24® Dietary Assessment Tool (ASA24; sodium intake), and pre-test knowledge on HTN will be obtained (using Qualitrics). Four weeks later, the participants were scheduled for a follow-up meeting to collect each participant's BP, ASA24, and post-test knowledge on HTN (using Qualitrics).
|
MOBILE Intervention Group
Intervention participants were required to take daily BP, provide their motivation level, and send them to the research assistant to receive the appropriate text messages.
Intervention group was asked to take their BP daily and rate their motivation level and communicate with the research assistant. Their level will trigger the appropriate behavioral change SMS prompt.: The investigators showed participants how to use the Health Mate app, upload Withings BP cuff readings, upload historical data to the cloud, read trend lines in their record, rank their daily motivational level, and answer a brief short message service (SMS) question about whether the participants completed the behavioral change task encouraged by the daily message. A one-page instruction sheet with the research team's contact information was provided. Participants were instructed to take their BP daily, before their first meal and encouraged to avoid prior alcohol and caffeine intake as well as physical activity. The participants were instructed to rate their motivational level as low, moderate, or high via SMS when transmitting their BP value. Their level will trigger the appropriate behavioral change SMS prompt.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
15
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MOBILE Intervention in College Students With Elevated Blood Pressure
Baseline characteristics by cohort
| Measure |
Control
n=14 Participants
Following the educational session, the control group participants' BP, ASA24® Dietary Assessment Tool (ASA24; sodium intake), and pre-test knowledge on HTN will be obtained (using Qualitrics). Four weeks later, the participants were scheduled for a follow-up meeting to collect each participant's BP, ASA24, and post-test knowledge on HTN (using Qualitrics).
|
MOBILE Intervention Group
n=15 Participants
Intervention participants were required to take daily BP, provide their motivation level, and send them to the research assistant to receive the appropriate text messages.
Intervention group was asked to take their BP daily and rate their motivation level and communicate with the research assistant. Their level will trigger the appropriate behavioral change SMS prompt.: The investigators showed participants how to use the Health Mate app, upload Withings BP cuff readings, upload historical data to the cloud, read trend lines in their record, rank their daily motivational level, and answer a brief short message service (SMS) question about whether the participants completed the behavioral change task encouraged by the daily message. A one-page instruction sheet with the research team's contact information was provided. Participants were instructed to take their BP daily, before their first meal and encouraged to avoid prior alcohol and caffeine intake as well as physical activity. The participants were instructed to rate their motivational level as low, moderate, or high via SMS when transmitting their BP value. Their level will trigger the appropriate behavioral change SMS prompt.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Mean
|
21.7 years
STANDARD_DEVIATION 2.40 • n=5 Participants
|
24.1 years
STANDARD_DEVIATION 3.03 • n=7 Participants
|
22.9 years
STANDARD_DEVIATION 2.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Blood Pressure
Systolic Blood Pressure
|
125.5 mm Hg
STANDARD_DEVIATION 12.04 • n=5 Participants
|
131.2 mm Hg
STANDARD_DEVIATION 11.30 • n=7 Participants
|
128.45 mm Hg
STANDARD_DEVIATION 11.81 • n=5 Participants
|
|
Blood Pressure
Diastolic Blood Pressure
|
80.9 mm Hg
STANDARD_DEVIATION 9.01 • n=5 Participants
|
80.6 mm Hg
STANDARD_DEVIATION 8.70 • n=7 Participants
|
80.7 mm Hg
STANDARD_DEVIATION 8.69 • n=5 Participants
|
|
Hypertension Knowledge-Level Scale (HK-LS)
|
17.14 units on a scale
STANDARD_DEVIATION 2.48 • n=5 Participants
|
17.87 units on a scale
STANDARD_DEVIATION 3.07 • n=7 Participants
|
17.52 units on a scale
STANDARD_DEVIATION 2.77 • n=5 Participants
|
|
Daily Sodium Intake
|
3765.5 mg
STANDARD_DEVIATION 1953.08 • n=5 Participants
|
3955.4 mg
STANDARD_DEVIATION 2530.53 • n=7 Participants
|
3863.77 mg
STANDARD_DEVIATION 2232.07 • n=5 Participants
|
|
Body mass index category
Underweight
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Body mass index category
Normal or Healthy Weight
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Body mass index category
Overweight
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Body mass index category
Obese
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Education
Undergraduate
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Education
Graduate
|
0 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Martial Status
Single
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Martial Status
Married or living together
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Martial Status
Divorced/Separated
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Insurance coverage
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Family History of Heart Disease
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Daily Caloric Intake
|
1874.2 calories
STANDARD_DEVIATION 752.16 • n=5 Participants
|
2446.5 calories
STANDARD_DEVIATION 1425.86 • n=7 Participants
|
2160.38 calories
STANDARD_DEVIATION 1155.95 • n=5 Participants
|
PRIMARY outcome
Timeframe: Average value from 28 daysPopulation: College students between ages 18-29
BP level (systolic and diastolic BP) was taken using the Withings Wireless BP cuff by the participant in the intervention group.
Outcome measures
| Measure |
Control
n=14 Participants
Following the educational session, the control group participants' BP, ASA24® Dietary Assessment Tool (ASA24; sodium intake), and pre-test knowledge on HTN will be obtained (using Qualitrics). Four weeks later, the participants were scheduled for a follow-up meeting to collect each participant's BP, ASA24, and post-test knowledge on HTN (using Qualitrics).
|
MOBILE Intervention Group
n=15 Participants
Intervention participants were required to take daily BP, provide their motivation level, and send them to the research assistant to receive the appropriate text messages.
Intervention group was asked to take their BP daily and rate their motivation level and communicate with the research assistant. Their level will trigger the appropriate behavioral change SMS prompt.: The investigators showed participants how to use the Health Mate app, upload Withings BP cuff readings, upload historical data to the cloud, read trend lines in their record, rank their daily motivational level, and answer a brief short message service (SMS) question about whether the participants completed the behavioral change task encouraged by the daily message. A one-page instruction sheet with the research team's contact information was provided. Participants were instructed to take their BP daily, before their first meal and encouraged to avoid prior alcohol and caffeine intake as well as physical activity. The participants were instructed to rate their motivational level as low, moderate, or high via SMS when transmitting their BP value. Their level will trigger the appropriate behavioral change SMS prompt.
|
|---|---|---|
|
BP Level
Systolic Blood Pressure
|
124.0 mm Hg
Standard Deviation 12.31
|
118.7 mm Hg
Standard Deviation 11.32
|
|
BP Level
Diastolic Blood Pressure
|
77.9 mm Hg
Standard Deviation 7.90
|
73.7 mm Hg
Standard Deviation 7.60
|
SECONDARY outcome
Timeframe: Average of Day 1 and Day 28Population: College students between the ages of 18-29.
ASA24 dietary intake were measured in all participants and sodium intake was evaluated using this measurement.
Outcome measures
| Measure |
Control
n=14 Participants
Following the educational session, the control group participants' BP, ASA24® Dietary Assessment Tool (ASA24; sodium intake), and pre-test knowledge on HTN will be obtained (using Qualitrics). Four weeks later, the participants were scheduled for a follow-up meeting to collect each participant's BP, ASA24, and post-test knowledge on HTN (using Qualitrics).
|
MOBILE Intervention Group
n=15 Participants
Intervention participants were required to take daily BP, provide their motivation level, and send them to the research assistant to receive the appropriate text messages.
Intervention group was asked to take their BP daily and rate their motivation level and communicate with the research assistant. Their level will trigger the appropriate behavioral change SMS prompt.: The investigators showed participants how to use the Health Mate app, upload Withings BP cuff readings, upload historical data to the cloud, read trend lines in their record, rank their daily motivational level, and answer a brief short message service (SMS) question about whether the participants completed the behavioral change task encouraged by the daily message. A one-page instruction sheet with the research team's contact information was provided. Participants were instructed to take their BP daily, before their first meal and encouraged to avoid prior alcohol and caffeine intake as well as physical activity. The participants were instructed to rate their motivational level as low, moderate, or high via SMS when transmitting their BP value. Their level will trigger the appropriate behavioral change SMS prompt.
|
|---|---|---|
|
Sodium Intake
|
3046.2 mg
Standard Deviation 1095.85
|
3799.39 mg
Standard Deviation 2540.8
|
SECONDARY outcome
Timeframe: Average of Day 1 and Day 28Assess all participants' knowledge on HTN using the Hypertension Knowledge-Level Scale (HK-LS). 6 sub-dimensions: definition, medical treatment, drug compliance, lifestyle, diet, and complications 22-item; Responses; Score ranges from 0-22; Higher scores reflect greater knowledge of HTN. Reliability: Cronbach's alpha 0.82 \& Validity: good content, face, and construct validity, test re-test reliability (0.79), and discriminative validity (0.27-\>0.40).
Outcome measures
| Measure |
Control
n=14 Participants
Following the educational session, the control group participants' BP, ASA24® Dietary Assessment Tool (ASA24; sodium intake), and pre-test knowledge on HTN will be obtained (using Qualitrics). Four weeks later, the participants were scheduled for a follow-up meeting to collect each participant's BP, ASA24, and post-test knowledge on HTN (using Qualitrics).
|
MOBILE Intervention Group
n=15 Participants
Intervention participants were required to take daily BP, provide their motivation level, and send them to the research assistant to receive the appropriate text messages.
Intervention group was asked to take their BP daily and rate their motivation level and communicate with the research assistant. Their level will trigger the appropriate behavioral change SMS prompt.: The investigators showed participants how to use the Health Mate app, upload Withings BP cuff readings, upload historical data to the cloud, read trend lines in their record, rank their daily motivational level, and answer a brief short message service (SMS) question about whether the participants completed the behavioral change task encouraged by the daily message. A one-page instruction sheet with the research team's contact information was provided. Participants were instructed to take their BP daily, before their first meal and encouraged to avoid prior alcohol and caffeine intake as well as physical activity. The participants were instructed to rate their motivational level as low, moderate, or high via SMS when transmitting their BP value. Their level will trigger the appropriate behavioral change SMS prompt.
|
|---|---|---|
|
HTN Knowledge
|
19.1 units on a scale
Standard Deviation 1.54
|
19.3 units on a scale
Standard Deviation 1.35
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MOBILE Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place