Hypertension
Conditions
Keywords
mhealth, hypertension, college students, self-monitoring, lifestyle modifications
Brief summary
The investigators' long-term goal is to develop tailored interventions to influence self-management behaviors in young adults with elevated blood pressure (BP). The investigators seek to test an intervention, mobile health (mHealth) to Optimize BP Improvement (MOBILE), that takes advantage of existing applications and our prior work to allow participants to (1) perform self-measured BP monitoring; (2) receive feedback from a cloud-based cardiovascular disease (CVD) detection platform; and (3) receive tailored text messages that encourage engagement in BP reduction behavior. mHealth technology provides an ideal way to deliver healthcare interventions to young adults. Text messaging is especially appealing to college students, more than 91% of whom use smartphones as their main communication device. For this study, the investigators will recruit 42 college students, ages 18 to 29, with elevated BP to participate in formative developmental project and then a 4-week two-armed trial of MOBILE. The aims of this study are: Aim 1. To refine the MOBILE intervention during a formative phase involving 8-10 students. Outcomes will include finalized motivation-level-tailored text messages designed to prompt behavior change and a self-administered motivational scale to be employed in the Aim 2 and Exploratory Aim study. Aim 2. To evaluate the feasibility of implementing the MOBILE intervention in 32 college students with elevated BP. The investigators will operationalize MOBILE feasibility as: (a) acceptability to participants, (b) participation rate, (c) texts delivered and opened, (d) fidelity to daily BP measurement protocol, (e) reported technical problems and challenges, and (f) recruitment and attrition rates. Exploratory Aim. To examine the preliminary impact of the MOBILE intervention on BP reduction (primary outcome) along with sodium intake and hypertension (HTN) knowledge improvement (secondary outcomes) among 32 college students with elevated BP. Hypothesis: The intervention group will have a significantly greater reduction in BP and sodium intake and greater increase in HTN knowledge from baseline to completion, compared to control group.
Detailed description
The investigators seek to test an intervention, mHealth to Optimize BP Improvement (MOBILE), that takes advantage of existing applications and our prior work to allow participants to (1) perform self-measured BP monitoring; (2) receive feedback from a cloud-based CVD detection platform; and (3) receive tailored text messages that encourage engagement in BP reduction behavior. mHealth technology provides an ideal way to deliver healthcare interventions to young adults.
Interventions
BEHAVIORALIntervention 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.
Sponsors
University of Nevada, Las Vegas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
No masking was done.
Intervention model description
Intervention group vs control group
Eligibility
Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
No
Inclusion criteria
Aim 1 Formative Phase: * Full-time (≥ 12 credits for undergraduate and ≥ 9 credits for graduate) college student at the University of Nevada, Las Vegas (UNLV) * Aged 18-29 years. Aim 2 Inclusion criteria: * Full-time (≥ 12 credits for undergraduate and ≥ 9 credits for graduate) college student at UNLV * Aged 18-29 years * Regular access to a mobile smart-phone with unlimited texting * Elevated BP (SBP 120-129 mm Hg and diastolic blood pressure \[DBP\] \<80 mm Hg) or undiagnosed HTN stage 1 (SBP 130-139 mm Hg or DBP 80-89 mm Hg). Interested participants who have HTN stage 2 (SBP \>140 mm Hg or DBP \>90 mm Hg) will need clearance from their primary healthcare provider to participate in the study.
Exclusion criteria
Aim 2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BP Level | Average value from 28 days | BP level (systolic and diastolic BP) was taken using the Withings Wireless BP cuff by the participant in the intervention group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sodium Intake | Average of Day 1 and Day 28 | ASA24 dietary intake were measured in all participants and sodium intake was evaluated using this measurement. |
| HTN Knowledge | Average of Day 1 and Day 28 | Assess 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). |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 14 |
| 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. | 15 |
| Total | 29 |
Baseline characteristics
| Characteristic | Control | MOBILE Intervention Group | Total |
|---|---|---|---|
| Age, Customized Mean | 21.7 years STANDARD_DEVIATION 2.4 | 24.1 years STANDARD_DEVIATION 3.03 | 22.9 years STANDARD_DEVIATION 2.95 |
| Blood Pressure Diastolic Blood Pressure | 80.9 mm Hg STANDARD_DEVIATION 9.01 | 80.6 mm Hg STANDARD_DEVIATION 8.7 | 80.7 mm Hg STANDARD_DEVIATION 8.69 |
| Blood Pressure Systolic Blood Pressure | 125.5 mm Hg STANDARD_DEVIATION 12.04 | 131.2 mm Hg STANDARD_DEVIATION 11.3 | 128.45 mm Hg STANDARD_DEVIATION 11.81 |
| Body mass index category Normal or Healthy Weight | 3 Participants | 4 Participants | 7 Participants |
| Body mass index category Obese | 6 Participants | 4 Participants | 10 Participants |
| Body mass index category Overweight | 4 Participants | 7 Participants | 11 Participants |
| Body mass index category Underweight | 1 Participants | 0 Participants | 1 Participants |
| Daily Caloric Intake | 1874.2 calories STANDARD_DEVIATION 752.16 | 2446.5 calories STANDARD_DEVIATION 1425.86 | 2160.38 calories STANDARD_DEVIATION 1155.95 |
| Daily Sodium Intake | 3765.5 mg STANDARD_DEVIATION 1953.08 | 3955.4 mg STANDARD_DEVIATION 2530.53 | 3863.77 mg STANDARD_DEVIATION 2232.07 |
| Education Graduate | 0 Participants | 9 Participants | 9 Participants |
| Education Undergraduate | 14 Participants | 6 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 6 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 9 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Family History of Heart Disease | 8 Participants | 4 Participants | 12 Participants |
| Hypertension Knowledge-Level Scale (HK-LS) | 17.14 units on a scale STANDARD_DEVIATION 2.48 | 17.87 units on a scale STANDARD_DEVIATION 3.07 | 17.52 units on a scale STANDARD_DEVIATION 2.77 |
| Insurance coverage | 12 Participants | 12 Participants | 24 Participants |
| Martial Status Divorced/Separated | 0 Participants | 1 Participants | 1 Participants |
| Martial Status Married or living together | 2 Participants | 3 Participants | 5 Participants |
| Martial Status Single | 12 Participants | 11 Participants | 23 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 8 Participants | 14 Participants |
| Region of Enrollment United States | 14 participants | 15 participants | 29 participants |
| Sex: Female, Male Female | 7 Participants | 9 Participants | 16 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 15 |
| other Total, other adverse events | 0 / 14 | 0 / 15 |
| serious Total, serious adverse events | 0 / 14 | 0 / 15 |
Outcome results
Primary
BP Level
BP level (systolic and diastolic BP) was taken using the Withings Wireless BP cuff by the participant in the intervention group.
Time frame: Average value from 28 days
Population: College students between ages 18-29
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | BP Level | Systolic Blood Pressure | 124.0 mm Hg | Standard Deviation 12.31 |
| Control | BP Level | Diastolic Blood Pressure | 77.9 mm Hg | Standard Deviation 7.9 |
| MOBILE Intervention Group | BP Level | Systolic Blood Pressure | 118.7 mm Hg | Standard Deviation 11.32 |
| MOBILE Intervention Group | BP Level | Diastolic Blood Pressure | 73.7 mm Hg | Standard Deviation 7.6 |
Secondary
HTN Knowledge
Assess 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).
Time frame: Average of Day 1 and Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | HTN Knowledge | 19.1 units on a scale | Standard Deviation 1.54 |
| MOBILE Intervention Group | HTN Knowledge | 19.3 units on a scale | Standard Deviation 1.35 |
Secondary
Sodium Intake
ASA24 dietary intake were measured in all participants and sodium intake was evaluated using this measurement.
Time frame: Average of Day 1 and Day 28
Population: College students between the ages of 18-29.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Sodium Intake | 3046.2 mg | Standard Deviation 1095.85 |
| MOBILE Intervention Group | Sodium Intake | 3799.39 mg | Standard Deviation 2540.8 |