Intellectual DisabilityNCT04573530
We Walk Plus Study for Older Adults With Intellectual Disabilities
A study testing We Walk Plus Intervention in people with Intellectual Disability, run by University of Illinois Chicago at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Intellectual Disability
- What is being tested?
- We Walk Plus Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jun 2021to 13 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Illinois at Chicago
Chicago, Illinois, 60608
Trinity Services Inc.
New Lenox, Illinois, 60451
About this study
Official title: We Walk Plus Study: A Walking Program Using Physical Activity Monitors and Social Networking for Older Adults With Intellectual Disabilities
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.
- Conditions
- Intellectual Disability
- Being tested
- We Walk Plus Intervention
- Keywords
- physical activity, walking, older adults with an intellectual disability
- Medical subject headings
- Intellectual Disability, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
We Walk Plus InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| We Walk Plus Intervention | Experimental | 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. Receives: Behavioral: We Walk Plus Intervention |
| Attention control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
daily steps
Measured: 12 weeks
Secondary outcomes (6)
Cardiovascular fitness
modified six-minute walk test
Measured: 12 weeks
Self-efficacy to physical activity
Physical Activity Self-efficacy/Social Support scale will be used to assess confidence to perform physical activity
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start15 Jun 2021
- Primary completion15 Jan 2026
- Study completion13 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Participants are randomized to the intervention or control group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kueifang Hsieh, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573530
- Sponsor's protocol ID
- 2020-1140
- Status last verified
- Aug 2026
- First submitted
- 14 Sep 2020
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- We Walk Plus Study: A Walking Program Using Physical Activity Monitors and Social Networking for Older Adults With Intellectual Disabilities
- ClinicalTrials.gov ID
- NCT04573530
- Acronym / sponsor ID
- 2020-1140
- Conditions
- Intellectual Disability
- Keywords
- physical activity, walking, older adults with an intellectual disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 13 Mar 2026 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine the feasibility and acceptability of We Walk Plus intervention to promote physical activity and improve cognition for older adults with intellectual disabilities (ID).
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized to the intervention or control group
| Arm | Type | Receives |
|---|---|---|
| We Walk Plus Intervention | Experimental | Behavioral: We Walk Plus InterventionThe 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. |
| Attention control group | No intervention | –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. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| We Walk Plus InterventionThe 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. | Behavioural | We Walk Plus Intervention |
Primary outcome
Physical activity
Time frame: 12 weeks
daily steps
6 secondary outcomes
Cardiovascular fitness
Time frame: 12 weeks
Self-efficacy to physical activity
Time frame: 12 weeks
Attention & executive function
Time frame: 12 weeks
Working memory
Time frame: 12 weeks
Executive function
Time frame: 12 weeks
Processing speed
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing We Walk Plus Intervention in people with Intellectual Disability, run by University of Illinois Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.