Using Smartphones to Improve Physical Activity Levels of Individuals With Spinal Cord Injury

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Temple University
Study ID
NCT05317832
Phase
PHASE2
Status
Recruiting
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Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • WI program — BEHAVIORAL
    This 14-week web-based physical activity intervention (WI) program was developed by the National Center on Health, Physical Activity and Disability. The WI program was developed with guidance from literature and practice in health behavior change and internet-based health promotion programming. The content and features of the WI program include motivational resource, updated weekly resources, and customizable features.
  • WI Program Reminder — BEHAVIORAL
    Participants will be provided with reminders to use the WI program
  • JITAI Goal Setting — BEHAVIORAL
    Participants will be provided with standard, tailored, or no goal for the day. The goal will focus on recommending minutes of moderate-intensity (or higher) physical activity and a reminder to perform strength exercises.
  • JITAI physical activity message — BEHAVIORAL
    Participants will be provided with minutes of moderate-intensity (or higher) physical activity achieved, minutes of physical activity remaining, or no message.
  • Notification EMA — OTHER
    Participants will be inquired through an ecological momentary assessment (EMA) if they received a JITAI physical activity message.
  • End of day EMA — OTHER
    Participants will be inquired, through an ecological momentary assessment (EMA), if they performed aerobic and/or strength exercises for the day.
  • Wake up time EMA — OTHER
    Participants will be inquired, through an ecological momentary assessment (EMA), about the time they plan to wake up next day. This information will be used to provide a goal setting message for next day.
  • Weekly PA Information — OTHER
    Participants will have access to minutes of moderate-intensity (or higher) physical activity performed over the last 7 days.
  • Daily PA Information — OTHER
    Participants will have access to minutes of moderate-intensity (or higher) physical activity performed over the day.

Study Details

The overarching goal of this research study is to evaluate a sensor-enabled, just-in-time adaptive intervention (JITAI) strategy to increase and sustain physical activity levels among individuals with spinal cord injury (SCI) in their communities. A primary objective of this study is to evaluate the integration of a JITAI with a web-based physical activity intervention program. We hypothesize that the integration of web-based physical activity intervention program with JITAI will result in significantly higher physical activity levels compared to the standard web-based physical activity intervention program alone. A secondary objective of this study is to extend existing algorithms that use commercial wearable technology to robustly detect physical activity behaviors to facilitate the delivery of tailored just-in-time actionable feedback and physical activity recommendations for individuals with SCI.

Key Dates

Start date
May 25, 2023
Status verified
Oct 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
196 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Web-based physical activity intervention (WI) program
    Participants in the WI arm will take part in the WI program (weeks 3 to 16). After the WI program is completed in week 16, the participants will transition to the physical activity sustainability phase which will include participants having continued access to the information provided during the WI program (weeks 17 to 24).
  • Experimental: Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI)
    Participants in the WI + JITAI arm will take part in the WI program (weeks 3 to 16). After the WI program is completed in week 16, the participants will transition to the physical activity sustainability phase which will include participants having continued access to the information provided during the WI program (weeks 17 to 24). In addition, participants will have access to the JITAI that will provide just-in-time feedback and physical activity recommendations (weeks 3 to 24). The type of the feedback and recommendation messages in the WI + JITAI arm will be delivered using micro-randomization, which involves random selection of intervention components at each possible time of delivery.

Primary Outcome Measure

Change in moderate-intensity (or higher) physical activity [ Time Frame: Baseline (week 2) and WI Program (week 16) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Temple UniversityPhiladelphiaPennsylvania19121
Shivayogi V Hiremath, PhD
[email protected]
215-204-0496
Shivayogi V Hiremath, PhD (PRINCIPAL_INVESTIGATOR)

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Temple University· Philadelphia, PA

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