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Completed

NCT Number: NCT02059382

EXercise Continuation Incorporating Technology Enhancements (EXCITE) Study

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.

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Key information

Conditions

Physical Inactivity Behavior Motor Activity Sedentary Behavior

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Osher Center for Integrative Medicine

San Francisco, California, 94115, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ChiRunning training

Behavioral

unblinded accelerometer

Behavioral

participation in online social network

Behavioral

participation in study website

Behavioral

Technology support for behavior change

Behavioral

Primary outcomes

  1. Feasibility of recruitment

    Time frame: End of 8 weeks of recruitment

    Meeting 75% of recruitment goal of 40 participants

  2. Feasibility of retention

    Time frame: End of 10 weeks of participation

    Retaining 75% of enrolled participants.

  3. Feasibility for participant adherence

    Time frame: 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

    Time frame: End of 10 weeks of active participation

    Did participants find study procedures acceptable?

Secondary outcomes

  1. Total number of new exercise related injury

    Time frame: 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

    Time frame: Measured through out the 10 weeks of active participation

    Daily step measured using a digital accelerometer.

  3. Average weekly MET min of structured exercise

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Acronym: EXCITE

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 11, 2014
Registry last updated
Jul 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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