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
|Condition or disease||Intervention/treatment||Phase|
|Intellectual Disability||Behavioral: We Walk Plus Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Participants are randomized to the intervention or control group|
|Masking:||None (Open Label)|
|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|
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.
- Physical activity [ Time Frame: 12 weeks ]daily steps
- Cardiovascular fitness [ Time Frame: 12 weeks ]modified six-minute walk test
- 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
- 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.
- 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.
- 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.
- 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.
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
|Contact: Kelly Hsieh, PhDfirstname.lastname@example.org|
|Contact: Andrew DeMott, MPHemail@example.com|
|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 firstname.lastname@example.org|