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CompletedNCT04573530Updated Aug 20, 2026

We Walk Plus Study for Older Adults With Intellectual Disabilities

An interventional study of We Walk Plus Intervention in Intellectual Disability, sponsored by University of Illinois at Chicago. Completed at 2 sites in United States. Open to participants aged 35 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Randomized
Ages
35 Years to 60 Years
Sex
All
01

Study summary

Determine the feasibility and acceptability of We Walk Plus intervention to promote physical activity and improve cognition for older adults with intellectual disabilities (ID).

Read the detailed description

We Walk Plus study consists of: (1) a user friendly physical activity tracker (i.e., Fitbit Charge HR ); (2) user-centered social networking (e.g., Fitbit community); and (3) the iCardia platform for monitoring daily Fitbit physical activity and wear time and sending personalized text-messages targeting physical activity and self-efficacy. The specific aims of this two-arm RCT pilot are to: 1) assess the feasibility and acceptability of the We Walk Plus intervention and 2) explore the preliminary efficacy of We Walk Plus on physical activity and well-being.

02

Conditions studied

  • Intellectual Disability

Keywords

  • physical activity
  • walking
  • older adults with an intellectual disability
03

In context

Intellectual Disability

363 studies on the registry are indexed under Intellectual Disability; 103 are open to participants now.

This study's enrollment of 53 is close to the median of 53 across 236 interventional studies indexed under Intellectual Disability.

Browse Intellectual Disability studies →

Lead sponsor

University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Men and women with mild or moderate intellectual disabilities;
  • ages 35-60;
  • able to speak, read English and willing to provide consent to enroll;
  • able to follow instructions and walk, physically inactive;
  • willing to receive SMS, wear Fitbit throughout the study;
  • living with family or in a community residence;
  • support persons are willing to assist participants to ensure the Fitbit functions properly.

Exclusion criteria

Exclusion Criteria:

  • Inability to follow instructions;
  • diagnosis of coronary disease or uncontrolled hypertension, smokers, physically active;
  • participating in a health promotion program;
  • having mental illness or behavior problems;
  • support persons unable or unwilling to assist participants with Fitbit devices, if needed.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    We Walk Plus Intervention

    The intervention group will receive a Fitbit, SMS and will be assigned to a private Fitbit community (4-5 participants per group) for 12 weeks. During the intervention, participants will receive weekly personalized SMS on their mobile phones including encouraging messages, reminders, and tips to increase steps, and weekly step goals. The investigators will use a secure, web-based platform, iCardia, to support continuous real-time remote monitoring of activity data from Fitbit devices and personalized communication via SMS based on incoming data. The investigators will set up the Fitbit networking settings on participants' phones to give notifications when there are posts to this group. Individual goals and a weekly team goal of steps will be set up by the research team. Each member will be awarded a badge upon reaching each individual's weekly goal. Teams will also be awarded badges when all team members reach their individual weekly goals.

    Behavioral: We Walk Plus Intervention

  • No intervention
    Attention control group

    The attention control group will also receive a Fitbit and will be asked to continue with normal daily activities. During the initial in-person session, they will receive the same PA recommendations as the intervention group to walk at least 30 minutes for 5 days or more a week or 10,000 steps a day. However, a plan for improving PA will not be discussed.

Interventions

  • BehavioralWe Walk Plus Intervention

    The frequency and content of weekly personalized SMS are based on each participant's preference. Prior to implementation of intervention, the investigators will conduct focus groups to learn participants' social network activities and preferences, strategies that can be used to encourage engagement via a private Fitbit community network.

06

What researchers measure

Primary outcomes

  1. Physical activity

    daily steps

    Time frame: 12 weeks

Secondary outcomes

  1. Cardiovascular fitness

    modified six-minute walk test

    Time frame: 12 weeks

  2. Self-efficacy to physical activity

    Physical Activity Self-efficacy/Social Support scale will be used to assess confidence to perform physical activity

    Time frame: 12 weeks

  3. Attention & executive function

    Flanker Inhibitory Control and Attention Test -a standard test from the NIH toolbox which has been adapted and validated for individuals with ID to assess one's limited capacities to deal with an abundance of environmental stimulation.

    Time frame: 12 weeks

  4. Working memory

    List Sorting Working Memory Test-a standard test from the NIH toolbox which has been adapted and validated for individuals with ID to assess the ability to store information.

    Time frame: 12 weeks

  5. Executive function

    Dimensional Change Card Sort Test -a standard test from the NIH toolbox which has been adapted and validated for individuals with ID to assess one's capacity to plan, organize, and monitor the executive of behaviors.

    Time frame: 12 weeks

  6. Processing speed

    Pattern Comparison Processing Speed Test- a standard test from the NIH toolbox which has been adapted and validated for individuals with ID to assess the amount of information that can be processed within a certain unit of time.

    Time frame: 12 weeks

07

Study locations

2 sites
  • University of Illinois at Chicago
    Chicago, Illinois 60608, United States
  • Trinity Services Inc.
    New Lenox, Illinois 60451, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04573530
Lead sponsor
University of Illinois at Chicago
Responsible party
Kueifang Hsieh (Research Associate Professor, University of Illinois at Chicago) — Principal investigator
First posted
Oct 5, 2020
Start date
Jun 15, 2021
Primary completion
Jan 15, 2026
Completion
Mar 13, 2026
Last update
Aug 20, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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