- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03061357
Physical Activity Intervention Among College Students
Incorporating Wearable Technology Into Physical Activity Instructional Program: A Cluster Randomized Trial in University Settings
Study Overview
Detailed Description
This project was a cluster randomized trial examining the effects of utilizing a wearable activity tracker in a credit-based Physical Activity Instructional Program on promoting habitual levels of physical activity (PA) in college students.
The project was conducted in a large public university located in the mid-south region of the US. The university offers more than one hundred 1-credit hour PAIPs per academic semester. Considering the pilot nature of the study, the target PAIPs was limited to those meeting the following inclusion criteria: 1) PAIP with a size of 30 students that generally show an approximately equal gender distribution; and 2) PAIP that delivers the principles and practice of individually tailored habitual activity plans. The investigators randomly selected 14 eligible PAIPs and assigned them into intervention (k=7) and control (k=7) groups. The outcome measures of interests were the changes in objectively and subjectively measured physical activity over an academic semester.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- healthy college students who were enrolled in 1-credit physical activity instruction programs.
Exclusion Criteria:
- did not wish to participate;
- have currently used their own wearable activity tracker;
- indicated any major physical, psychiatric, or cardiovascular-related problems diagnosed by a physician.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Activity tracker group
Participants in intervention arm were provided with a small and lightweight activity tracker, Misfit Flash (Misfit Wearables Co., Burlingame, CA), that can be worn with a clasp or watch band.
A handout detailing the step-by-step instructions for utilizing the activity tracker with Misfit App on their smartphone was provided.
There was no intervention component mandated in the curriculum of intervention PAIP courses; rather, participants were continuously encouraged by the instructors to track their activity levels and use all the features in Misfit App on a daily basis as they learned health benefits of PA and as to how to develop individualized, life-long PA plan during the course of semester.
|
Misfit Flash (Misfit Wearables Co., Burlingame, CA) activity tracker
|
No Intervention: Control group
Participants in control arm did not receive any additional instructions other than the scheduled class activities based on the standardized core-curriculum of PAIP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in objectively measured physical activity to 15 weeks
Time Frame: baseline and 15 weeks
|
Physical activity was objectively measured using an ActiGraph Actitrainer (ActiGraph LLC, Pensacola, FL, USA) accelerometer.
|
baseline and 15 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in subjectively measured physical activity
Time Frame: baseline and 15 weeks
|
Physical activity was subjectively measured using International Physical Activity Questionnaire.
|
baseline and 15 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Youngdeok Kim, PhD, Texas Tech University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 505314
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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