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MOBILE Intervention in College Students With Elevated Blood Pressure (MOBILE)

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
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.
Sponsored by
University of Nevada, Las Vegas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring mhealth, hypertension, college students, self-monitoring, lifestyle modifications

Eligibility Criteria

18 Years - 29 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Nevada Las Vegas

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

MOBILE Intervention Group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

BP level
Daily BP level (systolic and diastolic BP) taken using the Withings Wireless BP cuff by the participant in the intervention group.

Secondary Outcome Measures

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

Full Information

First Posted
June 22, 2023
Last Updated
July 13, 2023
Sponsor
University of Nevada, Las Vegas
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1. Study Identification

Unique Protocol Identification Number
NCT05956925
Brief Title
MOBILE Intervention in College Students With Elevated Blood Pressure
Acronym
MOBILE
Official Title
MOBILE Intervention in College Students With Elevated Blood Pressure: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 3, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nevada, Las Vegas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
mhealth, hypertension, college students, self-monitoring, lifestyle modifications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention group vs control group
Masking
None (Open Label)
Masking Description
No masking was done.
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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).
Arm Title
MOBILE Intervention Group
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
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.
Intervention Description
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 Outcome Measure Information:
Title
BP level
Description
Daily BP level (systolic and diastolic BP) taken using the Withings Wireless BP cuff by the participant in the intervention group.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Sodium intake
Description
ASA24 dietary intake were measured in all participants and sodium intake was evaluated using this measurement.
Time Frame
Day 1 and Day 28 of the 28 days
Title
HTN knowledge
Description
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
Day 1 and Day 28 of the 28 days
Other Pre-specified Outcome Measures:
Title
Motivation Level
Description
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.
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Nevada Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89154
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The pilot study has limited data.

Learn more about this trial

MOBILE Intervention in College Students With Elevated Blood Pressure

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