MOBILE Intervention in College Students With Elevated Blood Pressure

NCT05956925 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2024-08-19

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of Nevada, Las Vegas

    lead OTHER

Principal Investigators

  • Dieu-My T Tran, PhD, RN · University of Nevada, Las Vegas

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
29 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-03
Primary Completion
2021-06-30
Completion
2022-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05956925 on ClinicalTrials.gov