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Completed

NCT Number: NCT05956925

MOBILE Intervention in College Students With Elevated Blood Pressure

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nevada Las Vegas

Las Vegas, Nevada, 89154, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Behavioral

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.

Primary outcomes

  1. BP Level

    Time frame: 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 outcomes

  1. Sodium Intake

    Time frame: Average of Day 1 and Day 28

    ASA24 dietary intake were measured in all participants and sodium intake was evaluated using this measurement.

  2. HTN Knowledge

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Nevada, Las Vegas

Other

Registry information

Official study title

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

Acronym: MOBILE

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jul 24, 2023
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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