Exercise, Activity and Smoking in Young Adults (EASY-A)

January 22, 2018 updated by: University of Minnesota

Exercise to Promote Quit Attempts in Young Adults

The purpose of this study is to evaluate how physical activity levels change in young adults when they start a specific exercise program.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate how physical activity levels change in young adults when they start a specific exercise program. Physical activity levels will be monitored daily via a FitBit Flex. Outcome measures include number of minutes of activity per day and distance traveled per day.

Study Type

Interventional

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
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • DCRU

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-40 years old,
  • stable physical/mental health,
  • current smoker
  • currently minimally active,
  • ambulatory,
  • interested in increasing their physical activity,
  • willingness to attend weekly exercise intervention sessions at a SNAP Fitness location within 10 miles of the University of Minnesota campus,
  • the ability to comply with the study protocol and provide informed consent

Exclusion Criteria:

  • Contraindications to increasing physical activity including, but not limited to,
  • abnormal electrocardiogram or V02 test results,
  • high blood pressure (defined as systolic blood pressure over 165 or diastolic blood pressure over 100),
  • heart attack, acute (2 days) cardiac event or stroke in preceding six months,
  • unstable angina,
  • uncontrolled dysrhythmias causing hemodynamic compromise,
  • symptomatic severe aortic stenosis,
  • uncontrolled symptomatic heart failure,
  • acute pulmonary embolism or pulmonary infarction,
  • acute myocarditis or
  • pericarditis,
  • dissecting aneurism,
  • acute systemic infection and
  • unstable pulmonary or cardiovascular conditions.

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: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Intensity Interval Training/FitBit Flex
Meet with personal trainer once per week for 20-minute exercise session
Behavioral: High Intensity Interval Training
High Intensity Interval Training
Other Names:
  • FitBit Flex
Device: FitBit Flex
Use to measure increase in Physical Activity
Experimental: Moderate Intensity/FitBit Flex
Meet with personal trainer once per week for 30-minute exercise session and exercise two times a week outside of personal trainer
Device: FitBit Flex
Use to measure increase in Physical Activity
Behavioral: Moderate Intensity
Moderate Intensity Training
Placebo Comparator: Delayed Control/FtBit Flex
No exercise offered
Device: FitBit Flex
Use to measure increase in Physical Activity
Behavioral: Delayed Control
Delayed Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Increase in Physical Activity as assessed by FitBit
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

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

Sponsor

University of Minnesota

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

August 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

August 5, 2015

First Submitted That Met QC Criteria

August 17, 2015

First Posted (Estimate)

August 19, 2015

Study Record Updates

Last Update Posted (Actual)

January 24, 2018

Last Update Submitted That Met QC Criteria

January 22, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1505m70321

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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