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We Walk Plus Study for Older Adults With Intellectual Disabilities

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04573530
Recruitment Status : Recruiting
First Posted : October 5, 2020
Last Update Posted : March 25, 2022
Sponsor:
Information provided by (Responsible Party):
Kueifang "Kelly" Hsieh. PhD, University of Illinois at Chicago

Brief 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).

Condition or disease Intervention/treatment Phase
Intellectual Disability Behavioral: We Walk Plus Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Participants are randomized to the intervention or control group
Masking: None (Open Label)
Primary Purpose: Other
Official Title: We Walk Plus Study: A Walking Program Using Physical Activity Monitors and Social Networking for Older Adults With Intellectual Disabilities
Actual Study Start Date : January 27, 2022
Estimated Primary Completion Date : September 15, 2022
Estimated Study Completion Date : September 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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.

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.



Primary Outcome Measures :
  1. Physical activity [ Time Frame: 12 weeks ]
    daily steps


Secondary Outcome Measures :
  1. Cardiovascular fitness [ Time Frame: 12 weeks ]
    modified six-minute walk test

  2. Self-efficacy to physical activity [ Time Frame: 12 weeks ]
    Physical Activity Self-efficacy/Social Support scale will be used to assess confidence to perform physical activity

  3. Attention & executive function [ Time Frame: 12 weeks ]
    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.

  4. Working memory [ Time Frame: 12 weeks ]
    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.

  5. Executive function [ Time Frame: 12 weeks ]
    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.

  6. Processing speed [ Time Frame: 12 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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.

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): NCT04573530


Contacts
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Contact: Kelly Hsieh, PhD 3124131530 hsieh@uic.edu
Contact: Andrew DeMott, MPH 3123553174 ademot1@uic.edu

Locations
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United States, Illinois
University of Illinois at Chicago Not yet recruiting
Chicago, Illinois, United States, 60608
Trinity Services Inc. Recruiting
New Lenox, Illinois, United States, 60451
Contact: Tina Fogarty    815-717-3750    tfogarty@trinityservices.org   
Sponsors and Collaborators
University of Illinois at Chicago
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Responsible Party: Kueifang "Kelly" Hsieh. PhD, Research Associate Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT04573530    
Other Study ID Numbers: 2020-1140
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: March 25, 2022
Last Verified: March 2022

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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 Kueifang "Kelly" Hsieh. PhD, University of Illinois at Chicago:
physical activity
walking
older adults with an intellectual disability
Additional relevant MeSH terms:
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Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurodevelopmental Disorders
Mental Disorders