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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04095923
Other study ID # 19-0158
Secondary ID R01AG064092
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2019
Est. completion date May 31, 2025

Study information

Verified date June 2023
Source The University of Texas Medical Branch, Galveston
Contact Eloisa Martinez, BS
Phone 409-266-9643
Email esmartin@utmb.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date May 31, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 65 Years to 85 Years
Eligibility Inclusion Criteria: 1. Female 2. Age between 65 and 85 3. Able to read and understand English 4. Willingness to be randomized to any condition 5. Daily availability of an iOS or Android mobile device that is capable of taking and sending photos 6. Willingness to use a private Facebook group 7. Sufficient internet access to post photos to Facebook at least once per week 8. Having an existing Facebook account or willingness to create one Exclusion Criteria: 1. Unable to find transportation to the study location 2. Unable to walk for exercise (self-report) 3. Walk <475 meters in 6 minute walk test during baseline assessment 4. Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months 5. 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 6. Self-reported weekly PA = 150 minutes 7. BMI under 18 or over 40 8. Participant reports psychological issues that would interfere with study completion. Examples will be provided to illustrate potential psychological issues, such as dementia or schizophrenia. 9. 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 10. Clinical judgment concerning safety 11. Currently participating in an organized commercial or research physical activity program 12. Uses a wearable activity monitor other than a simple pedometer and is unwilling to stop during the trial 13. Another member of the household is a participant or staff member on this trial

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Social media game
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.
Standard self-regulation
Participants will track their steps using a wearable activity monitor and receive brief standard self-regulatory counseling.

Locations

Country Name City State
United States The University of Texas Medical Branch Galveston Texas

Sponsors (3)

Lead Sponsor Collaborator
The University of Texas Medical Branch, Galveston M.D. Anderson Cancer Center, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Exercise identity Perceptions of exercise identity on a scale from 1 (strongly disagree) to 7 (strongly agree) on the Exercise Identity Scale Baseline to 6 months
Other Engaged living 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
Other Playful experiences 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
Other Usability 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
Other Acceptability of walking challenge game Self-reported acceptability of challenges on a scale of 1 (strongly disagree) to 5 (strongly agree) Baseline to 6 months
Other Engagement in the social media group Objectively measured number of posts, comments, and reactions in the Facebook group Baseline to 12 months
Other Days the activity monitor was worn Objectively measured days the wearable activity monitor was worn during the intervention period Baseline to 12 months
Other Enjoyment of each weekly challenge 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
Primary Walking physical activity as measured by daily steps at 12 months Mean of daily steps taken from accelerometers worn for a 7 day period Baseline to 12 months
Secondary Walking physical activity as measured by daily steps at 6 months Mean of daily steps taken from accelerometers worn for a 7 day period Baseline to 6 months
Secondary Walking physical activity as measured by daily steps at 18 months Mean of daily steps taken from accelerometers worn for a 7 day period Baseline to 18 months
Secondary Intrinsic regulation 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
Secondary Integrated regulation 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
Secondary Autonomous regulation 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
Secondary Basic psychological needs 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
Secondary Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months Mean daily minutes of moderate-vigorous intensity physical activity taken from accelerometers for a 7 day period Baseline to 6 months
Secondary Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 12 months Mean daily minutes of moderate-vigorous intensity physical activity taken from accelerometers for a 7 day period Baseline to 12 months
Secondary Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 18 months Mean daily minutes of moderate-vigorous intensity physical activity taken from accelerometers for a 7 day period Baseline to 18 months
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