Clinical trial NCT05956925: MOBILE Intervention in College Students With Elevated Blood Pressure
Official title: MOBILE Intervention in College Students With Elevated Blood Pressure: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: mhealth
hypertension
college students
self-monitoring
lifestyle modifications
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group vs control group
Primary purpose: PREVENTION

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.

Eligibility criteria: 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 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.

Primary outcomes:
measure: BP Level
timeFrame: Average value from 28 days
Secondary outcomes:
measure: Sodium Intake
timeFrame: Average of Day 1 and Day 28
measure: HTN Knowledge
timeFrame: Average of Day 1 and Day 28
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: University of Nevada Las Vegas
state: Nevada
Study officials:
affiliation: University of Nevada, Las Vegas
name: Dieu-My T Tran, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: