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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02496728
Other study ID # 14SFRN20480260
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2015
Est. completion date February 28, 2019

Study information

Verified date May 2019
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 302
Est. completion date February 28, 2019
Est. primary completion date February 28, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 17 Years to 26 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Northwestern University Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
Northwestern University American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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