NCT02059382

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 11, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 31, 2014

Status Verified

July 1, 2014

Enrollment Period

10 months

First QC Date

December 24, 2013

Last Update Submit

July 29, 2014

Conditions

Keywords

daily physical activityexercisesocial supportonline social network

Outcome Measures

Primary Outcomes (4)

  • Feasibility of recruitment

    Meeting 75% of recruitment goal of 40 participants

    End of 8 weeks of recruitment

  • Feasibility of retention

    Retaining 75% of enrolled participants.

    End of 10 weeks of participation

  • 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

  • Acceptability of study procedures

    Did participants find study procedures acceptable?

    End of 10 weeks of active participation

Secondary Outcomes (7)

  • Total number of new exercise related injury

    Measured through out the 10 weeks of active participation

  • Average weekly physical activity in steps

    Measured through out the 10 weeks of active participation

  • Average weekly MET min of structured exercise

    Measured through out the 10 weeks of active participation

  • Change in mindfulness

    Baseline and end of 10 weeks of active participation

  • Change in body awareness

    Baseline and end of 10 weeks of active participation

  • +2 more secondary outcomes

Study Arms (2)

Control

ACTIVE COMPARATOR

ChiRunning training Weekly training log Blinded accelerometer

Behavioral: ChiRunning training

Technology support for behavior change

EXPERIMENTAL

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

Behavioral: ChiRunning trainingBehavioral: unblinded accelerometerBehavioral: participation in online social networkBehavioral: participation in study websiteBehavioral: Technology support for behavior change

Interventions

ControlTechnology support for behavior change
Technology support for behavior change
Technology support for behavior change
Technology support for behavior change
Technology support for behavior change

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osher Center for Integrative Medicine

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Kelly McDermott, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2013

First Posted

February 11, 2014

Study Start

August 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

July 31, 2014

Record last verified: 2014-07

Locations