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Clinical Trials/NCT05385016
NCT05385016
Completed
Not Applicable

The Promotion of Healthy Lifestyles for Young Adults With Intellectual Disabilities

University of Kansas Medical Center1 site in 1 country21 target enrollmentMay 24, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intellectual Disability, Mild to Moderate
Sponsor
University of Kansas Medical Center
Enrollment
21
Locations
1
Primary Endpoint
Retention
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The purpose of this study is to examine the feasibility and initial efficacy of a healthy lifestyles intervention for the prevention of weight gain and the promotion of basic life skills related to improving health in transition age young adults with intellectual disabilities.

Detailed Description

This is a single arm, longitudinal trial. 30 young adults with intellectual disabilities will be recruited to participate in a 12-week, healthy lifestyles intervention, delivered in person to a group of individuals with ID at the Center for Children's Healthy Lifestyles and Nutrition. Participants will be asked to attend one 2 hr group session each week (\~5-6 participants per group). All sessions will have an education component, a hands-on nutrition/cooking lesson, and a group exercise session. Additionally, participants will be asked to attend a 20-minute monthly individual goal setting session conducted remotely over Zoom video conferencing. All sessions will be conducted by a trained health educator experienced in working with individuals with intellectual disabilities. Tablet computers and Fitbit wireless activity monitors will be provided to all participants, with study issued HIPPA compliant Zoom and Fitbit accounts. Outcome assessments will be collected at baseline and after the 12-week intervention.

Registry
clinicaltrials.gov
Start Date
May 24, 2022
End Date
October 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of an Intellectual Disability.
  • Age: 18-30 yrs.
  • Functional ability sufficient to understand directions and to communicate through spoken language.
  • Reside in a supported living condition either at home or with no more than 1-4 residents and have a study partner (i.e., parent, staff who agrees to serve as support partner).
  • Wireless Internet access in the home.
  • Ability to walk without assistance.
  • Consent from physician to do physical activity.

Exclusion Criteria

  • Actively participating in another research study

Outcomes

Primary Outcomes

Retention

Time Frame: Across 12 weeks

We will calculate the percent of participants who complete the 12 week intervention.

Attendance

Time Frame: Across 12 weeks

The health coach will record attendance at all sessions. The outcome variable will be the percentage of attendance out of the total 12 scheduled exercise sessions attended.

Secondary Outcomes

  • Height(Change from Baseline to 12 weeks)
  • Fitness(Change from Baseline to 12 weeks)
  • Lower Body Strength(Change from Baseline to 12 weeks)
  • Waist circumference(Change from Baseline to 12 weeks)
  • Individual Goals(Across 12 weeks)
  • Upper Body Strength(Change from Baseline to 12 weeks)
  • Daily Physical Activity(Across 12 weeks)
  • Cooking Skills(Change from Baseline to 12 weeks)
  • Weight(Change from Baseline to 12 weeks)
  • Body Mass Index(Change from Baseline to 12 weeks)
  • Caregiver Stress(Change from Baseline to 12 weeks)
  • Work Capacity(Across 12 weeks)
  • Accelerometer(Change from Baseline to 12 weeks.)

Study Sites (1)

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