Physical ActivityNCT03061357
Physical Activity Intervention Among College Students
A study testing Activity tracker in people with Physical Activity, run by Texas Tech University.
Trial summary
This project was to examine the effects of incorporating modern wearable technology into the credit-based Physical Activity Instructional Program for promoting habitual levels of physical activity among college students. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Activity tracker
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- No sites listed yet
- Study dates
- 6 Aug 2015to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- healthy college students who were enrolled in 1-credit physical activity instruction programs.
Who cannot join
- 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.
About this study
Official title: Incorporating Wearable Technology Into Physical Activity Instructional Program: A Cluster Randomized Trial in University Settings
This project was to examine the effects of incorporating modern wearable technology into the credit-based Physical Activity Instructional Program for promoting habitual levels of physical activity among college students.
Read the 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.
- Conditions
- Physical Activity
- Being tested
- Activity tracker
- Keywords
- activity tracker, behavior change
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity trackerBehavioural
Misfit Flash (Misfit Wearables Co., Burlingame, CA) activity tracker
| Study group | Role | What they receive |
|---|---|---|
| Activity tracker group | Experimental | 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. Receives: Behavioral: Activity tracker |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in objectively measured physical activity to 15 weeks
Physical activity was objectively measured using an ActiGraph Actitrainer (ActiGraph LLC, Pensacola, FL, USA) accelerometer.
Measured: baseline and 15 weeks
Secondary outcomes (1)
Change from baseline in subjectively measured physical activity
Physical activity was subjectively measured using International Physical Activity Questionnaire.
Measured: baseline and 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start6 Aug 2015
- Primary completion31 Jul 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youngdeok Kim, Texas Tech University
- Investigators
- Youngdeok Kim, PhD, Principal investigator, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061357
- Sponsor's protocol ID
- 505314
- Status last verified
- Feb 2017
- First submitted
- 9 Feb 2017
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporating Wearable Technology Into Physical Activity Instructional Program: A Cluster Randomized Trial in University Settings
- ClinicalTrials.gov ID
- NCT03061357
- Acronym / sponsor ID
- 505314
- Conditions
- Physical Activity
- Keywords
- activity tracker, behavior change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Study start
- 6 Aug 2015 (actual)
- Primary completion
- 31 Jul 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project was to examine the effects of incorporating modern wearable technology into the credit-based Physical Activity Instructional Program for promoting habitual levels of physical activity among college students.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activity tracker group | Experimental | Behavioral: Activity trackerParticipants 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. |
| Control group | No intervention | –Participants in control arm did not receive any additional instructions other than the scheduled class activities based on the standardized core-curriculum of PAIP |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- healthy college students who were enrolled in 1-credit physical activity instruction programs.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activity trackerMisfit Flash (Misfit Wearables Co., Burlingame, CA) activity tracker | Behavioural | Activity tracker group |
Primary outcome
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.
1 secondary outcome
Change from baseline in subjectively measured physical activity
Time frame: baseline and 15 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Youngdeok Kim, PhD principal investigator
Texas Tech University
Questions about this trial
What is this clinical trial studying?
A study testing Activity tracker in people with Physical Activity, run by Texas Tech University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in objectively measured physical activity to 15 weeks (time frame: baseline and 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.