HypertensionMOBILENCT05956925
MOBILE Intervention in College Students With Elevated Blood Pressure
A study testing 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. in people with Hypertension, run by University of Nevada, Las Vegas at 1 site in United States.
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, mobile health (mHealth) to Optimize BP Improvement (MOBILE), that takes advantage of existing applications and… Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Hypertension
- What is being tested?
- 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.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nevada Las Vegas
Las Vegas, Nevada, 89154
About this study
Official title: MOBILE Intervention in College Students With Elevated Blood Pressure: A Pilot Study
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.
Read more
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- 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.
- Keywords
- mhealth, hypertension, college students, self-monitoring, lifestyle modifications
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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). |
| MOBILE Intervention Group | Experimental | 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BP Level
BP level (systolic and diastolic BP) was taken using the Withings Wireless BP cuff by the participant in the intervention group.
Measured: Average value from 28 days
Secondary outcomes (2)
Sodium Intake
ASA24 dietary intake were measured in all participants and sodium intake was evaluated using this measurement.
Measured: Average of Day 1 and Day 28
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).
Measured: Average of Day 1 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start3 Dec 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group vs control group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dieu-My T Tran, PhD, RN, Principal investigator, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956925
- Sponsor's protocol ID
- 1565271
- Acronym
- MOBILE
- Status last verified
- Mar 2024
- First submitted
- 22 Jun 2023
- Last updated
- 19 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The pilot study has limited data.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOBILE Intervention in College Students With Elevated Blood Pressure: A Pilot Study
- ClinicalTrials.gov ID
- NCT05956925
- Acronym / sponsor ID
- MOBILE / 1565271
- Conditions
- Hypertension
- Keywords
- mhealth, hypertension, college students, self-monitoring, lifestyle modifications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 24 Jul 2023 (actual)
- Results
- Posted 19 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention group vs control group
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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). |
| MOBILE Intervention Group | Experimental | 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.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. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | MOBILE Intervention Group |
Primary outcome
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.
2 secondary outcomes
Sodium Intake
Time frame: Average of Day 1 and Day 28
HTN Knowledge
Time frame: Average of Day 1 and Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The pilot study has limited data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dieu-My T Tran, PhD, RN principal investigator
University of Nevada, Las Vegas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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. in people with Hypertension, run by University of Nevada, Las Vegas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BP Level (time frame: Average value from 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.