NUYou:mHealth Intervention to Preserve and Promote Ideal Cardiovascular Health (NUYou)

May 17, 2019 updated by: Bonnie Spring, Northwestern University

American Heart Association Strategically Focused Research Network: mHealth Intervention to Preserve and Promote Ideal Cardiovascular Health

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

302

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 26 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Behavioral: Mobile Health Application
An application on a smart phone that is designed to help individuals self-monitor health behaviors.
Behavioral: Environmental Cues
Text messages, informational posts and reminders supporting healthy behaviors.
Behavioral: Social Support
Participants may interact with each other through a private Facebook group.
Behavioral: Educational Materials
Educational materials regarding healthy behaviors.
Active Comparator: 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).
Behavioral: Mobile Health Application
An application on a smart phone that is designed to help individuals self-monitor health behaviors.
Behavioral: Environmental Cues
Text messages, informational posts and reminders supporting healthy behaviors.
Behavioral: Social Support
Participants may interact with each other through a private Facebook group.
Behavioral: Educational Materials
Educational materials regarding healthy behaviors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American Heart Association MyLifeCheck (Simple 7) score as a measure of cardiovascular health
Time Frame: 2 years
Participant's Simple 7 score is the sum of 7 cardiovascular health metrics attained at ideal levels as defined by American Heart Association. 1) physically active - Exercising at least 150 minutes of moderate or 75 minutes of vigorous physical activity per week. 2) Good diet quality - Eating 5 servings of fruits and vegetables per day, at least 3 servings of whole grain, and no more than 16 oz. of soda per day, rarely or never eats high sodium foods or processed meats. 3) nonsmoking - nonsmoker for at least a year. 4) not overweight - BMI < 25 kg/m2. 5) normoglycemic - fasting glucose < 100 mg/dl. 6) not hypercholesterolemic : total Cholesterol < 200 mg/dl. 7) not hypertensive. Blood Pressure <120/<80.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

American Heart Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

February 28, 2019

Study Completion (Actual)

February 28, 2019

Study Registration Dates

First Submitted

May 29, 2015

First Submitted That Met QC Criteria

July 9, 2015

First Posted (Estimate)

July 14, 2015

Study Record Updates

Last Update Posted (Actual)

May 20, 2019

Last Update Submitted That Met QC Criteria

May 17, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14SFRN20480260

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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