NCT04573530

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

June 15, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2026

Completed
Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

4.6 years

First QC Date

September 14, 2020

Last Update Submit

December 12, 2025

Conditions

Keywords

physical activitywalkingolder adults with an intellectual disability

Outcome Measures

Primary Outcomes (1)

  • Physical activity

    daily steps

    12 weeks

Secondary Outcomes (6)

  • Cardiovascular fitness

    12 weeks

  • Self-efficacy to physical activity

    12 weeks

  • Attention & executive function

    12 weeks

  • Working memory

    12 weeks

  • Executive function

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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.

We Walk Plus Intervention

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Illinois at Chicago

Chicago, Illinois, 60608, United States

Location

Trinity Services Inc.

New Lenox, Illinois, 60451, United States

Location

MeSH Terms

Conditions

Intellectual DisabilityMotor Activity

Interventions

Methods

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: Participants are randomized to the intervention or control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

September 14, 2020

First Posted

October 5, 2020

Study Start

June 15, 2021

Primary Completion

January 15, 2026

Study Completion

February 15, 2026

Last Updated

December 15, 2025

Record last verified: 2025-12

Locations