NUYou:mHealth Intervention to Preserve and Promote Ideal Cardiovascular Health

NCT ID: NCT02496728

Last Updated: 2019-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2019-02-28

Brief Summary

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The purpose of the study is to investigate the preservation or promotion of health in students during the college years.

Detailed Description

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Freshman college students at Northwestern University will be cluster randomized to two groups based on their dorm. The intervention for one group will target smoking, physical activity, BMI and consumption of fruits and vegetables. The intervention in the second group will target traveling behavior, sexual risk behaviors, sunscreen use and hydration. Baseline health and lifestyle measures will be assessed for each participant prior to intervention. Health assessments will measure height, weight, fasting glucose, total cholesterol and carbon monoxide. The lifestyle measure will ask questions about physical activity, diet, alcohol and tobacco use, safe sex practices, driving habits, and sunscreen use. These same measures will be repeated during the fall of the students' sophomore and junior years.

Participants will be given a mobile application and encouraged to track some behaviors. In addition, participants will be asked to answer weekly questions regarding health behaviors.

Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cardiovascular Health

Participants will be given the results of their health assessment and feedback regarding their health behaviors and overall health. Recommendations for change will be given if warranted. Participants will download the study's mobile health application on their smartphone. They will then be asked to report once a week about their health behaviors on the application. Participants will also be asked to self-monitor health behaviors that are not already at ideal levels using the study application (environmental cues). Participants will be asked to join a secret Facebook group where informational materials will be posted, participants can post about study health behaviors and social interaction around health behaviors can occur (social support and environmental cues).

Group Type EXPERIMENTAL

Mobile Health Application

Intervention Type BEHAVIORAL

An application on a smart phone that is designed to help individuals self-monitor health behaviors.

Environmental Cues

Intervention Type BEHAVIORAL

Text messages, informational posts and reminders supporting healthy behaviors.

Social Support

Intervention Type BEHAVIORAL

Participants may interact with each other through a private Facebook group.

Educational Materials

Intervention Type BEHAVIORAL

Educational materials regarding healthy behaviors.

Whole Health

Participants will be given the results of their health assessment. They will then receive educational materials about sunscreen use, safe sex, hydration and vehicular safety. Participants will download the study's mobile health application on their smartphone. They will then be asked to report once a week about their health behaviors on the application. Participants will also be asked to self-monitor how much water they drink using the study application. Participants will be asked to join a secret Facebook group where informational materials will be posted, they can post about study health behaviors and social interaction around health behaviors can occur (social support and environmental cues).

Group Type ACTIVE_COMPARATOR

Mobile Health Application

Intervention Type BEHAVIORAL

An application on a smart phone that is designed to help individuals self-monitor health behaviors.

Environmental Cues

Intervention Type BEHAVIORAL

Text messages, informational posts and reminders supporting healthy behaviors.

Social Support

Intervention Type BEHAVIORAL

Participants may interact with each other through a private Facebook group.

Educational Materials

Intervention Type BEHAVIORAL

Educational materials regarding healthy behaviors.

Interventions

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Mobile Health Application

An application on a smart phone that is designed to help individuals self-monitor health behaviors.

Intervention Type BEHAVIORAL

Environmental Cues

Text messages, informational posts and reminders supporting healthy behaviors.

Intervention Type BEHAVIORAL

Social Support

Participants may interact with each other through a private Facebook group.

Intervention Type BEHAVIORAL

Educational Materials

Educational materials regarding healthy behaviors.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Freshman at Northwestern University in the fall of 2015
* Live on campus
* Read, write and speak English
* Own an Iphone or Android smart phone

Exclusion Criteria

* Pregnant or trying to become pregnant
* Established cardiovascular disease
* Unstable psychiatric or medical condition
Minimum Eligible Age

17 Years

Maximum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Bonnie Spring

Professor Preventive Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bonnie Spring, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Pfammatter AF, Champion KE, Finch LE, Siddique J, Hedeker D, Spring B. A mHealth intervention to preserve and promote ideal cardiovascular health in college students: Design and protocol of a cluster randomized controlled trial. Contemp Clin Trials. 2020 Nov;98:106162. doi: 10.1016/j.cct.2020.106162. Epub 2020 Oct 8.

Reference Type DERIVED
PMID: 33038506 (View on PubMed)

Other Identifiers

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14SFRN20480260

Identifier Type: -

Identifier Source: org_study_id

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