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Physical InactivityEXCITENCT02059382

EXercise Continuation Incorporating Technology Enhancements (EXCITE) Study

A study testing ChiRunning training, unblinded accelerometer and participation in online social network in people with Physical Inactivity, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Physical Inactivity
What is being tested?
ChiRunning training, unblinded accelerometer and participation in online social network
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
Aug 2013to Jun 2014
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 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Osher Center for Integrative Medicine

    San Francisco, California, 94115

Other trials in United States

About this 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.

Being tested
ChiRunning training, unblinded accelerometer, participation in online social network, participation in study website, Technology support for behavior change
Keywords
daily physical activity, exercise, social support, online social network
Medical subject headings
Sedentary Behavior, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChiRunning trainingBehavioural

  • unblinded accelerometerBehavioural

  • participation in online social networkBehavioural

  • participation in study websiteBehavioural

  • Technology support for behavior changeBehavioural

Study groups in NCT02059382
Study groupRoleWhat they receive
ControlActive comparatorChiRunning training Weekly training log Blinded accelerometer
Receives: Behavioral: ChiRunning training
Technology support for behavior changeExperimentalChiRunning training unblinded accelerometer tracking structured exercise using mobile app participation in online social network participation in study website
Receives: Behavioral: ChiRunning training; Behavioral: unblinded accelerometer; Behavioral: participation in online social network; Behavioral: participation in study website; Behavioral: Technology support for behavior change

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of recruitment

    Meeting 75% of recruitment goal of 40 participants

    Measured: End of 8 weeks of recruitment

  2. Feasibility of retention

    Retaining 75% of enrolled participants.

    Measured: End of 10 weeks of participation

  3. Feasibility for participant adherence

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

    Measured: Measured through out the 10 weeks of active participation

  4. Acceptability of study procedures

    Did participants find study procedures acceptable?

    Measured: End of 10 weeks of active participation

Secondary outcomes (7)

  1. Total number of new exercise related injury

    Measure of pain or injury associated with structured exercise.

    Measured: Measured through out the 10 weeks of active participation

  2. Average weekly physical activity in steps

    Daily step measured using a digital accelerometer.

    Measured: Measured through out the 10 weeks of active participation

  3. 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: Measured through out the 10 weeks of active participation

  4. 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 α=0.75-0.91.

    Measured: Baseline and end of 10 weeks of active participation

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

    Measured: Baseline and end of 10 weeks of active participation

  6. 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).

    Measured: Baseline and end of 10 weeks of active participation

  7. 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.

    Measured: Baseline and end of 10 weeks of active participation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2014 (estimated)
  2. Study startAug 2013
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02059382
Sponsor's protocol ID
13-10688
Acronym
EXCITE
Status last verified
Jul 2014
First submitted
24 Dec 2013
Last updated
31 Jul 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing ChiRunning training, unblinded accelerometer and participation in online social network in people with Physical Inactivity, run by University of California, San Francisco at 1 site in United States.

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 5 inclusion and 2 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 31 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Feasibility of recruitment (time frame: End of 8 weeks of recruitment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02059382.

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 31 Jul 2014.

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