A Social Media Game to Increase Physical Activity Among Older Adult Women (CHALLENGE)

• ClinicalTrials.gov Identifier: NCT04095923
• Recruitment Status: Recruiting
• First Posted: September 19, 2019
• Last Update Posted: June 10, 2022
• Sponsor: The University of Texas Medical Branch, Galveston
• Collaborators: National Institute on Aging (NIA); M.D. Anderson Cancer Center
• Information provided by (Responsible Party): The University of Texas Medical Branch, Galveston

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Aging	Behavioral: Social media game; Behavioral: Standard self-regulation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Social Media Game to Increase Physical Activity Among Older Adult Women
• Actual Study Start Date: December 1, 2019
• Estimated Primary Completion Date: January 1, 2024
• Estimated Study Completion Date: May 31, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Social media game; Private Facebook group with weekly walking challenges, Fitbit wearable activity monitor, and brief counseling	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.
Active Comparator: Standard self-regulation; Fitbit wearable activity monitor and brief counseling	Behavioral: Standard self-regulation; Participants will track their steps using a wearable activity monitor and receive brief standard self-regulatory counseling.

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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
2. 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
3. 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
4. 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
5. 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
6. 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
7. 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
8. 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
9. 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

Other Outcome Measures:

1. 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
2. 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
3. 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
4. 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
5. 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)
6. Engagement in the social media group [ Time Frame: Baseline to 12 months ]
   Objectively measured number of posts, comments, and reactions in the Facebook group
7. 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
8. 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)

Eligibility Criteria

• Ages Eligible for Study: 65 Years to 85 Years (Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Participants must self-report as women
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Contacts

Contact: Eloisa Martinez, BS; 409-266-9643; esmartin@utmb.edu

Contact: Elizabeth Lyons, PhD, MPH; 409-772-2575; ellyons@utmb.edu

Locations

United States, Texas

The University of Texas Medical Branch; Recruiting

Galveston, Texas, United States, 77550

Contact: Eloisa Martinez 409-266-9643 esmartin@utmb.edu

Principal Investigator: Elizabeth J Lyons, PhD, MPH

Sponsors and Collaborators

The University of Texas Medical Branch, Galveston

National Institute on Aging (NIA)

M.D. Anderson Cancer Center

Investigators

• Principal Investigator: Elizabeth Lyons, PhD, MPH; University of Texas

More Information

• Responsible Party: The University of Texas Medical Branch, Galveston
• ClinicalTrials.gov Identifier: NCT04095923
• Other Study ID Numbers: 19-0158; R01AG064092 ( U.S. NIH Grant/Contract )
• First Posted: September 19, 2019
• Last Update Posted: June 10, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP)
• Time Frame: Data will only be available upon request
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The University of Texas Medical Branch, Galveston:

Physical activity; Social media; Wearable; Intrinsic motivation; Game; Women's health