We Walk Plus Study for Older Adults With Intellectual Disabilities

Intellectual Disability Clinical Trial

Official title:

We Walk Plus Study: A Walking Program Using Physical Activity Monitors and Social Networking for Older Adults With Intellectual Disabilities

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04573530
• Other study ID #: 2020-1140
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2021
• Est. completion date: October 30, 2024

Study information

• Verified date: May 2024
• Source: University of Illinois at Chicago
• Contact: Kelly Hsieh, PhD
• Phone: 3124131530
• Email: hsieh[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: October 30, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intellectual Disability

Intervention

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.

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Trinity Services Inc.	New Lenox	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity	daily steps	12 weeks
Secondary	Cardiovascular fitness	modified six-minute walk test	12 weeks
Secondary	Self-efficacy to physical activity	Physical Activity Self-efficacy/Social Support scale will be used to assess confidence to perform physical activity	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks