Clinical trial NCT02059382: EXercise Continuation Incorporating Technology Enhancements (EXCITE) Study
Official title: EXercise Continuation Incorporating Technology Enhancements (EXCITE) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Inactivity
Keywords: daily physical activity
exercise
social support
online social network
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2014-02-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to inform the integration of mobile and social media components into larger interventions aimed at increasing adherence and maintenance of physical activity. Nearly half of the US population do not meet physical activity recommendations of ≥150 minutes of moderate activity per week. The use of smartphones to "self track" data and upload that data to an online social network is becoming increasingly common and may be an effective way to motivate physical activity adherence and maintenance. We are proposing a two phase study to develop and evaluate a mobile health ("mHealth") intervention that includes the use of two existing technologies: 1) the RunKeeper mobile app to collect and upload exercise data (distance, pace, time), and 2) the RunKeeper.com online social network as a place to analyze uploaded data and engage with a coach and online community. Phase 1 (n=10) will iteratively develop the mHealth intervention and phase 2 (n=30) will pilot the mHealth intervention (participants will be randomized to either mHealth intervention (n=20) or control (n=10)) to collect feasibility, acceptability and preliminary efficacy data. All participants will attend a day-long ChiWalk/Run training to help them avoid potential injuries and meet their coach and community in-person. All participants will also be asked to wear a FitBit accelerometer from one week before the beginning of the intervention through one week after the end of the intervention to collect total physical activity data. This data will be uploaded automatically to the study data base. Primary outcomes will be total physical activity as collected by the FitBit accelerometer (and the RunKeeper mobile app for the intervention group) and secondary outcomes will be changes in psychological factors that may mediate adherence to physical activity.


Eligibility criteria: Inclusion Criteria:

* healthy underactive adults interested in using mobile and web based technologies to increase their physical activity
* low risk of cardiovascular disease
* comfortable reading and communicating in English
* owns a smartphone and is does not regularly use a fitness tracking mobile app
* has regular access to the internet and a wireless connection for data uploading.

Exclusion Criteria:

* currently meeting/exceeding recommend 450 MET min per week
* previous condition that would contraindicate regular moderate to vigorous physical activity

Primary outcomes:
measure: Feasibility of recruitment
timeFrame: End of 8 weeks of recruitment
measure: Feasibility of retention
timeFrame: End of 10 weeks of participation
measure: Feasibility for participant adherence
timeFrame: Measured through out the 10 weeks of active participation
measure: Acceptability of study procedures
timeFrame: End of 10 weeks of active participation
Secondary outcomes:
measure: Total number of new exercise related injury
timeFrame: Measured through out the 10 weeks of active participation
measure: Average weekly physical activity in steps
timeFrame: Measured through out the 10 weeks of active participation
measure: Average weekly MET min of structured exercise
timeFrame: Measured through out the 10 weeks of active participation
measure: Change in mindfulness
timeFrame: Baseline and end of 10 weeks of active participation
measure: Change in body awareness
timeFrame: Baseline and end of 10 weeks of active participation
measure: Change in exercise self efficacy
timeFrame: Baseline and end of 10 weeks of active participation
measure: Change in social support
timeFrame: Baseline and end of 10 weeks of active participation
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Osher Center for Integrative Medicine
state: California
Study officials:
affiliation: University of California, San Francisco
name: Kelly McDermott, PhD
role: PRINCIPAL_INVESTIGATOR
References: