MOBILE Intervention in College Students With Elevated Blood Pressure

Hypertension Clinical Trial

— MOBILE  

Official title:

MOBILE Intervention in College Students With Elevated Blood Pressure: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05956925
• Other study ID #: 1565271
• Status: Completed
• Phase: N/A
• Start date: December 3, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2023
• Source: University of Nevada, Las Vegas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

Inclusion Criteria:

Aim 1 Formative Phase:

• Full-time (= 12 credits for undergraduate and = 9 credits for graduate) college student at 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 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 Exclusion criteria:

• Taking antihypertensive medication (e.g. angiotensin-converting enzyme [ACE] inhibitors, angiotensin II receptor blockers [ARBs], calcium channel blockers [CCBs], beta-blockers, diuretics, or vasodilators)

• Currently pregnant, lactating, or planning to become pregnant during the study duration

• Having diabetes mellitus, hyperlipidemia, or a life-threatening illness or condition associated with HTN.

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Nevada Las Vegas	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
University of Nevada, Las Vegas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Motivation Level	Daily motivation level was assessed in the intervention group (1 low, 3 moderate, 5 high motivation). From a scale of 1 through 5, 5 being the highest motivation to be able to complete the most difficult tasks whereas 1 being the lowest motivation and therefore can and should complete simple tasks.	28 days
Primary	BP level	Daily BP level (systolic and diastolic BP) taken using the Withings Wireless BP cuff by the participant in the intervention group.	28 days
Secondary	Sodium intake	ASA24 dietary intake were measured in all participants and sodium intake was evaluated using this measurement.	Day 1 and Day 28 of the 28 days
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).	Day 1 and Day 28 of the 28 days