EXercise Continuation Incorporating Technology Enhancements (EXCITE) Study

Physical Inactivity Clinical Trial

— EXCITE  

Official title:

EXercise Continuation Incorporating Technology Enhancements (EXCITE) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02059382
• Other study ID #: 13-10688
• Status: Completed
• Phase: N/A
• First received: December 24, 2013
• Last updated: July 29, 2014
• Start date: August 2013
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Physical Inactivity

Intervention

Behavioral:
• ChiRunning training

• unblinded accelerometer

• participation in online social network

• participation in study website

• Technology support for behavior change

Locations

Country	Name	City	State
United States	Osher Center for Integrative Medicine	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of recruitment	Meeting 75% of recruitment goal of 40 participants	End of 8 weeks of recruitment	No
Primary	Feasibility of retention	Retaining 75% of enrolled participants.	End of 10 weeks of participation	No
Primary	Feasibility for participant adherence	Whether participants complete at least 75% of the exercise that they committed to at the beginning of the study.	Measured through out the 10 weeks of active participation	No
Primary	Acceptability of study procedures	Did participants find study procedures acceptable?	End of 10 weeks of active participation	No
Secondary	Total number of new exercise related injury	Measure of pain or injury associated with structured exercise.	Measured through out the 10 weeks of active participation	Yes
Secondary	Average weekly physical activity in steps	Daily step measured using a digital accelerometer.	Measured through out the 10 weeks of active participation	No
Secondary	Average weekly MET min of structured exercise	Average weekly metabolic equivalent of task (MET) minutes are a measure of time and intensity of physical activity.	Measured through out the 10 weeks of active participation	No
Secondary	Change in mindfulness	We will use the Five Factor Mindfulness Questionnaire (FFMQ) to assess changes in mindfulness. FFMQ is a 39-item questionnaire with five subscales (observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience) and a summary score ranging from 39 to 195. Internal consistencies range from a=0.75-0.91.	Baseline and end of 10 weeks of active participation	No
Secondary	Change in body awareness	We used the Multi-dimensional Assessment of Interoceptive Awareness (MAIA) to measure body awareness. MAIA is a 32-item questionnaire with eight separately scored scales. .We used 3 of the 8 scales most relevant for an exercise intervention to assess body awareness. The subscales we used were: 1) Self-Regulation: ability to regulate distress by attention to body sensations; 2) Body Listening: active listening to the body for insight; 3) Trusting: experience of one's body as safe and trustworthy. Scales range from 0-5 with higher numbers representing higher aspects of body awareness with internal consistencies of a=0.83; 0.82; 0.79 on the Self-Regulation, Body Listening, and Trusting subscales, respectively.	Baseline and end of 10 weeks of active participation	No
Secondary	Change in exercise self efficacy	We will be using Multidimensional Self-Efficacy for Exercise Scale (MSES) to assess exercise related self efficacy. MSES is a 9-item instrument used to assess three dimension of exercise related self efficacy (task, scheduling and coping).	Baseline and end of 10 weeks of active participation	No
Secondary	Change in social support	We will use the Social support and exercise survey (SSES) to assess social support. SSES is 26 item survey of social support for exercise available to the individual using separate (13 item) scales each for friends and for family.	Baseline and end of 10 weeks of active participation	No