NCT04095923

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

5.7 years

First QC Date

September 17, 2019

Last Update Submit

September 24, 2025

Conditions

Keywords

Physical activitySocial mediaWearableIntrinsic motivationGameWomen's health

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Walking physical activity as measured by daily steps at 6 months

    Baseline to 6 months

  • Walking physical activity as measured by daily steps at 18 months

    Baseline to 18 months

  • Intrinsic regulation

    Baseline to 6 months

  • Integrated regulation

    Baseline to 6 months

  • Autonomous regulation

    Baseline to 6 months

  • +4 more secondary outcomes

Other Outcomes (8)

  • Exercise identity

    Baseline to 6 months

  • Engaged living

    Baseline to 6 months

  • Playful experiences

    Baseline to 6 months

  • +5 more other outcomes

Study Arms (2)

Social media game

EXPERIMENTAL

Private Facebook group with weekly walking challenges, Fitbit wearable activity monitor, and brief counseling

Behavioral: Social media game

Standard self-regulation

ACTIVE COMPARATOR

Fitbit wearable activity monitor and brief counseling

Behavioral: Standard self-regulation

Interventions

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.

Social media game

Participants will track their steps using a wearable activity monitor and receive brief standard self-regulatory counseling.

Standard self-regulation

Eligibility Criteria

Age65 Years - 85 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipants must self-report as women
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Medical Branch

Galveston, Texas, 77550, United States

Location

Related Publications (1)

  • Robertson MC, Swartz MC, Basen-Engquist KM, Li Y, Jennings K, Thompson D, Baranowski T, Volpi E, Lyons EJ. A social media game to increase physical activity among older adult women: protocol of a randomized controlled trial to evaluate CHALLENGE. BMC Public Health. 2024 Aug 12;24(1):2172. doi: 10.1186/s12889-024-19662-9.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Elizabeth Lyons, PhD, MPH

    University of Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2019

First Posted

September 19, 2019

Study Start

December 1, 2019

Primary Completion

August 13, 2025

Study Completion

February 28, 2026

Last Updated

September 26, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, 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.

Locations