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Trial record 1 of 297 for:    lyons Elizabeth
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A Social Media Game to Increase Physical Activity Among Older Adult Women (CHALLENGE)

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ClinicalTrials.gov Identifier: NCT04095923
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : December 17, 2019
Sponsor:
Collaborators:
National Institute on Aging (NIA)
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

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.

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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 31, 2024
Estimated Study Completion Date : October 31, 2024

Resource links provided by the National Library of Medicine


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.




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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04095923


Contacts
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Contact: Eloisa Martinez, BS 409-266-9643 esmartin@utmb.edu
Contact: Elizabeth Lyons, PhD, MPH 409-772-2575 ellyons@utmb.edu

Locations
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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
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Principal Investigator: Elizabeth Lyons, PhD, MPH University of Texas
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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT04095923    
Other Study ID Numbers: 19-0158
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019
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.

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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