NCT02496728

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
302

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

May 20, 2019

Status Verified

May 1, 2019

Enrollment Period

3.8 years

First QC Date

May 29, 2015

Last Update Submit

May 17, 2019

Conditions

Keywords

Mobile HealthSmartphoneCardiovascular healthCollege studentsSmokingPhysical activityDietBMIBlood pressureCholesterolGlucoseTextFacebookInstagramPush NotificationsEcological Momentary Assessment

Outcome Measures

Primary Outcomes (1)

  • American Heart Association MyLifeCheck (Simple 7) score as a measure of cardiovascular health

    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

Study Arms (2)

Cardiovascular Health

EXPERIMENTAL

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 ApplicationBehavioral: Environmental CuesBehavioral: Social SupportBehavioral: Educational Materials

Whole Health

ACTIVE COMPARATOR

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 ApplicationBehavioral: Environmental CuesBehavioral: Social SupportBehavioral: Educational Materials

Interventions

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

Cardiovascular HealthWhole Health

Text messages, informational posts and reminders supporting healthy behaviors.

Cardiovascular HealthWhole Health
Social SupportBEHAVIORAL

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

Cardiovascular HealthWhole Health

Educational materials regarding healthy behaviors.

Cardiovascular HealthWhole Health

Eligibility Criteria

Age17 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Pregnant or trying to become pregnant
  • Established cardiovascular disease
  • Unstable psychiatric or medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Cardiovascular DiseasesSmokingMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Bonnie Spring, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Preventive Medicine

Study Record Dates

First Submitted

May 29, 2015

First Posted

July 14, 2015

Study Start

May 1, 2015

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

May 20, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations