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We Walk Plus Study for Older Adults With Intellectual Disabilities

Primary Purpose

Intellectual Disability

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
We Walk Plus Intervention
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Intellectual Disability focused on measuring physical activity, walking, older adults with an intellectual disability

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Illinois at Chicago
  • Trinity Services Inc.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

We Walk Plus Intervention

Attention control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Physical activity
daily steps

Secondary Outcome Measures

Cardiovascular fitness
modified six-minute walk test
Self-efficacy to physical activity
Physical Activity Self-efficacy/Social Support scale will be used to assess confidence to perform physical activity
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.
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.
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.
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.

Full Information

First Posted
September 14, 2020
Last Updated
May 5, 2023
Sponsor
University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT04573530
Brief Title
We Walk Plus Study for Older Adults With Intellectual Disabilities
Official Title
We Walk Plus Study: A Walking Program Using Physical Activity Monitors and Social Networking for Older Adults With Intellectual Disabilities
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2021 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intellectual Disability
Keywords
physical activity, walking, older adults with an intellectual disability

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Participants are randomized to the intervention or control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
We Walk Plus Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
We Walk Plus Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical activity
Description
daily steps
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Cardiovascular fitness
Description
modified six-minute walk test
Time Frame
12 weeks
Title
Self-efficacy to physical activity
Description
Physical Activity Self-efficacy/Social Support scale will be used to assess confidence to perform physical activity
Time Frame
12 weeks
Title
Attention & executive function
Description
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
Title
Working memory
Description
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
Title
Executive function
Description
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
Title
Processing speed
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Hsieh, PhD
Phone
3124131530
Email
hsieh@uic.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew DeMott, MPH
Phone
3123553174
Email
ademot1@uic.edu
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Trinity Services Inc.
City
New Lenox
State/Province
Illinois
ZIP/Postal Code
60451
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tina Fogarty
Phone
815-717-3750
Email
tfogarty@trinityservices.org

12. IPD Sharing Statement

Learn more about this trial

We Walk Plus Study for Older Adults With Intellectual Disabilities

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