EXercise Continuation Incorporating Technology Enhancements (EXCITE) Study

Sponsor
University of California, San Francisco (Other)
Overall Status
Completed
CT.gov ID
NCT02059382
Collaborator
(none)
40
1
2
10
4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: ChiRunning training
  • Behavioral: unblinded accelerometer
  • Behavioral: participation in online social network
  • Behavioral: participation in study website
  • Behavioral: Technology support for behavior change
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
EXercise Continuation Incorporating Technology Enhancements (EXCITE) Study
Study Start Date :
Aug 1, 2013
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control

ChiRunning training Weekly training log Blinded accelerometer

Behavioral: ChiRunning training

Experimental: Technology support for behavior change

ChiRunning training unblinded accelerometer tracking structured exercise using mobile app participation in online social network participation in study website

Behavioral: ChiRunning training

Behavioral: unblinded accelerometer

Behavioral: participation in online social network

Behavioral: participation in study website

Behavioral: Technology support for behavior change

Outcome Measures

Primary Outcome Measures

  1. Feasibility of recruitment [End of 8 weeks of recruitment]

    Meeting 75% of recruitment goal of 40 participants

  2. Feasibility of retention [End of 10 weeks of participation]

    Retaining 75% of enrolled participants.

  3. Feasibility for participant adherence [Measured through out the 10 weeks of active participation]

    Whether participants complete at least 75% of the exercise that they committed to at the beginning of the study.

  4. Acceptability of study procedures [End of 10 weeks of active participation]

    Did participants find study procedures acceptable?

Secondary Outcome Measures

  1. Total number of new exercise related injury [Measured through out the 10 weeks of active participation]

    Measure of pain or injury associated with structured exercise.

  2. Average weekly physical activity in steps [Measured through out the 10 weeks of active participation]

    Daily step measured using a digital accelerometer.

  3. Average weekly MET min of structured exercise [Measured through out the 10 weeks of active participation]

    Average weekly metabolic equivalent of task (MET) minutes are a measure of time and intensity of physical activity.

  4. Change in mindfulness [Baseline and end of 10 weeks of active participation]

    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 α=0.75-0.91.

  5. Change in body awareness [Baseline and end of 10 weeks of active participation]

    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 α=0.83; 0.82; 0.79 on the Self-Regulation, Body Listening, and Trusting subscales, respectively.

  6. Change in exercise self efficacy [Baseline and end of 10 weeks of active participation]

    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).

  7. Change in social support [Baseline and end of 10 weeks of active participation]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Osher Center for Integrative Medicine San Francisco California United States 94115

Sponsors and Collaborators

  • University of California, San Francisco

Investigators

  • Principal Investigator: Kelly McDermott, PhD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02059382
Other Study ID Numbers:
  • 13-10688
First Posted:
Feb 11, 2014
Last Update Posted:
Jul 31, 2014
Last Verified:
Jul 1, 2014
Keywords provided by University of California, San Francisco

Study Results

No Results Posted as of Jul 31, 2014