- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04095923
A Social Media Game to Increase Physical Activity Among Older Adult Women (CHALLENGE)
June 26, 2023 updated by: The University of Texas Medical Branch, Galveston
This study will test the effects of a social media game on the physical activity of older adult women.
The game will consist of playful weekly challenges that require sharing photographs on a private social media group and also wearing an activity monitor to track steps.
Participants will be randomized to this game group or to receive the activity monitor only.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Older adult women are at risk for negative health impacts of physical inactivity, but current strategies to increase their activity have had disappointing long-term results.
The intervention tested in this study seeks to test an innovative intervention that targets older womens' perceptions of enjoyment and their personal identity and values.
The investigators will test the efficacy of a 12-month social media-based physical activity intervention for sedentary older adult women.
Participants will be randomized to receive a standard Fitbit-only intervention or to an enhanced Fitbit + weekly social challenges intervention.
The investigators hypothesize that participants in the enhanced intervention will demonstrate greater increases in autonomous regulation and objectively-measured steps as compared to those in the standard intervention.
The investigators will also measure outcomes after a 6 month maintenance period (18 months after beginning the intervention).
Additional outcomes will include engagement with the social network and self-reported playful experiences.
Study Type
Interventional
Enrollment (Estimated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eloisa Martinez, BS
- Phone Number: 409-266-9643
- Email: esmartin@utmb.edu
Study Contact Backup
- Name: Elizabeth Lyons, PhD, MPH
- Phone Number: 409-772-2575
- Email: ellyons@utmb.edu
Study Locations
-
-
Texas
-
Galveston, Texas, United States, 77550
- Recruiting
- The University of Texas Medical Branch
-
Contact:
- Eloisa Martinez
- Phone Number: 409-266-9643
- Email: esmartin@utmb.edu
-
Principal Investigator:
- Elizabeth J Lyons, PhD, MPH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 85 years (Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Female
- Age between 65 and 85
- Able to read and understand English
- Willingness to be randomized to any condition
- Daily availability of an iOS or Android mobile device that is capable of taking and sending photos
- Willingness to use a private Facebook group
- Sufficient internet access to post photos to Facebook at least once per week
- Having an existing Facebook account or willingness to create one
Exclusion Criteria:
- Unable to find transportation to the study location
- Unable to walk for exercise (self-report)
- Walk <475 meters in 6 minute walk test during baseline assessment
- Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
- Participant answered "yes" to any question on the PAR-Q+ and does not provide a doctor's note giving permission to begin a physical activity program
- Self-reported weekly PA ≥ 150 minutes
- BMI under 18 or over 40
- Participant reports psychological issues that would interfere with study completion. Examples will be provided to illustrate potential psychological issues, such as dementia or schizophrenia.
- Participant plans to move away from the Galveston-Houston area or to be out of town for more than 2 weeks at a time during the study period
- Clinical judgment concerning safety
- Currently participating in an organized commercial or research physical activity program
- Uses a wearable activity monitor other than a simple pedometer and is unwilling to stop during the trial
- Another member of the household is a participant or staff member on this trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Social media game
Private Facebook group with weekly walking challenges, Fitbit wearable activity monitor, and brief counseling
|
Participants will engage in weekly challenges that require them to take photographs of interesting things they discover during their walks.
They will post and discuss these photographs with other participants on a private social media page.
They will track their steps using a wearable activity monitor and receive brief standard self-regulatory counseling.
|
Active Comparator: Standard self-regulation
Fitbit wearable activity monitor and brief counseling
|
Participants will track their steps using a wearable activity monitor and receive brief standard self-regulatory counseling.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Walking physical activity as measured by daily steps at 12 months
Time Frame: Baseline to 12 months
|
Mean of daily steps taken from accelerometers worn for a 7 day period
|
Baseline to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Walking physical activity as measured by daily steps at 6 months
Time Frame: Baseline to 6 months
|
Mean of daily steps taken from accelerometers worn for a 7 day period
|
Baseline to 6 months
|
Walking physical activity as measured by daily steps at 18 months
Time Frame: Baseline to 18 months
|
Mean of daily steps taken from accelerometers worn for a 7 day period
|
Baseline to 18 months
|
Intrinsic regulation
Time Frame: Baseline to 6 months
|
Self-reported intrinsic regulation on a scale from 0 (least motivated) to 4 (most motivated) using the Behavioral Regulation in Exercise Questionnaire - 3
|
Baseline to 6 months
|
Integrated regulation
Time Frame: Baseline to 6 months
|
Self-reported integrated regulation on a scale from 0 (least motivated) to 4 (most motivated) using the Behavioral Regulation in Exercise Questionnaire - 3
|
Baseline to 6 months
|
Autonomous regulation
Time Frame: Baseline to 6 months
|
Composite of subscales for intrinsic, integrated, and identified regulation as measured on a scale from 0 (least motivated) to 4 (most motivated) using the Behavioral Regulation in Exercise Questionnaire - 3
|
Baseline to 6 months
|
Basic psychological needs
Time Frame: Baseline to 6 months
|
Perceptions of autonomy, competence, and relatedness on a scale from 1 (don't agree) to 5 (completely agree) using the Psychological Needs in Exercise Scale
|
Baseline to 6 months
|
Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months
Time Frame: Baseline to 6 months
|
Mean daily minutes of moderate-vigorous intensity physical activity taken from accelerometers for a 7 day period
|
Baseline to 6 months
|
Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 12 months
Time Frame: Baseline to 12 months
|
Mean daily minutes of moderate-vigorous intensity physical activity taken from accelerometers for a 7 day period
|
Baseline to 12 months
|
Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 18 months
Time Frame: Baseline to 18 months
|
Mean daily minutes of moderate-vigorous intensity physical activity taken from accelerometers for a 7 day period
|
Baseline to 18 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exercise identity
Time Frame: Baseline to 6 months
|
Perceptions of exercise identity on a scale from 1 (strongly disagree) to 7 (strongly agree) on the Exercise Identity Scale
|
Baseline to 6 months
|
Engaged living
Time Frame: Baseline to 6 months
|
Perceptions of value-based living on a scale of 1 (completely disagree) to 5 (completely agree) on the Engaged Living Questionnaire
|
Baseline to 6 months
|
Playful experiences
Time Frame: Baseline to 6 months
|
Self-reported playful experiences during play of the game on a scale of 1 (totally disagree) to 5 (totally agree) using the Playful Experiences Questionnaire
|
Baseline to 6 months
|
Usability
Time Frame: Baseline to 6 months
|
Self-reported usability of the social media group on a scale of 1 (strongly disagree) to 5 (strongly agree) using the System Usability Scale
|
Baseline to 6 months
|
Acceptability of walking challenge game
Time Frame: Baseline to 6 months
|
Self-reported acceptability of challenges on a scale of 1 (strongly disagree) to 5 (strongly agree)
|
Baseline to 6 months
|
Engagement in the social media group
Time Frame: Baseline to 12 months
|
Objectively measured number of posts, comments, and reactions in the Facebook group
|
Baseline to 12 months
|
Days the activity monitor was worn
Time Frame: Baseline to 12 months
|
Objectively measured days the wearable activity monitor was worn during the intervention period
|
Baseline to 12 months
|
Enjoyment of each weekly challenge
Time Frame: Baseline to 12 months
|
Self-reported enjoyment measured via weekly text message inquiring as to enjoyment on a scale from 1 (strongly disagree) to 7 (strongly agree)
|
Baseline to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Elizabeth Lyons, PhD, MPH, University of Texas
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2019
Primary Completion (Estimated)
January 1, 2025
Study Completion (Estimated)
May 31, 2025
Study Registration Dates
First Submitted
September 17, 2019
First Submitted That Met QC Criteria
September 17, 2019
First Posted (Actual)
September 19, 2019
Study Record Updates
Last Update Posted (Actual)
June 27, 2023
Last Update Submitted That Met QC Criteria
June 26, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 19-0158
- R01AG064092 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The investigators will provide access to all data, regardless of publication, collected as a part of this project.
All external investigators must submit a written request identifying their research question(s) and specifying the data they would like to analyze.
The request must include a data security plan and explanation of how the data will be stored and who will have access.
All requests will be reviewed by the investigators in conjunction with UTMB's Institute for Translational Sciences key resources (in particular, the regulatory and ethics resources) to be sure appropriate NIH requirements are followed.
IPD Sharing Time Frame
Data will only be available upon request
IPD Sharing Access Criteria
All external investigators must submit a written request identifying their research question(s) and specifying the data they would like to analyze.
The request must include a data security plan and explanation of how the data will be stored and who will have access.
All requests will be reviewed by the investigators in conjunction with UTMB's Institute for Translational Sciences key resources (in particular, the regulatory and ethics resources) to be sure appropriate NIH requirements are followed.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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