Promotion of Physical Activity in Adolescents With Intellectual and Developmental Disabilities

Physical Activity Clinical Trial

Official title:

Individual and Family-based Approaches to Increase Physical Activity in Adolescents With IDD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03684512
• Other study ID #: STUDY00140784
• Secondary ID: R01HD094704
• Status: Completed
• Phase: N/A
• Start date: January 7, 2019
• Est. completion date: October 28, 2022

Study information

• Verified date: June 2023
• Source: University of Kansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to compare the effect of two strategies to increase MVPA in adolescents with intellectual and developmental disabilities (IDD): a single level intervention delivered to the adolescent only, and a multi-level intervention delivered to both the adolescent and a parent .

Description:

We will study adolescents with mild to moderate IDD. Each participant will have 1 designated parent who supports the participant during the physical activity (PA) intervention and in the adolescent and parent arm does the physical activity with the participant. Approximately 29 participants/yr. over 4 yrs. will be randomized in a 1:1 allocation to a remote group-based program of MVPA delivered to the adolescent (AO) or a multi-level intervention delivered to both the adolescent and a parent (A+P). Both interventions will be 12 mos. (6 mos. active intervention, 6 mos. maintenance intervention) with a 6 mos. no-contact follow-up targeted to increase MVPA to the recommended 60 min/d. Both intervention will include real-time MVPA sessions delivered to groups of 5-7 adolescents in their homes using video conferencing software (ZoomTM) with homework assignments designed to increase MVPA on the non-group session days. Parents of adolescents in the A+P group will be asked to participate in the group video MVPA sessions and homework activity, and to attend sessions (0-6 mos. 2 session/mo.; 7-12 mos. 1 session/mo.) with their adolescent and the health coach designed to educate/support parents regarding the role of MVPA in health and function and strategies for increasing MVPA and decreasing sedentary time in both their adolescent and themselves. All participants will monitor their daily PA using a Fitbit wireless activity tracker.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: October 28, 2022
• Est. primary completion date: October 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 21 Years

Eligibility

Inclusion Criteria:

• Mild to moderate IDD (IQ of 74-40).
• Sufficient functional ability to understand directions, communicate preferences, wants, and needs through spoken language.
• Living at home with a parent or guardian who is willing to participate in the intervention, with no plans to change this living situation and/or to leave the study area in the next 18 mos.
• Wireless internet access in the home.

Exclusion Criteria:

• Unable to participate in moderate to vigorous physical activity (MVPA).
• Pregnancy during the previous 6 mos., currently lactating, or planned pregnancy in the following 18 mos.
• Unwilling to be randomized.

Related Conditions & MeSH terms

• Adolescent Behavior
• Down Syndrome
• Intellectual Disability
• Physical Activity

Intervention

Behavioral:
• Group Exercise Sessions
Remote exercise sessions delivered over group video conference
• Individual Support Sessions
Individual education/support/feedback sessions delivered over video chat
• Facebook Group
Facebook group for parents to provide additional support and education

Locations

Country	Name	City	State
United States	University of Kansas	Lawrence	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Adolescent Physical Activity From Baseline to 6 Months	Moderate to vigorous physical activity was assessed using an ActiGraph accelerometer worn during waking hours for 7 consecutive days, with the exception of bathing, and swimming. Data were considered valid if they wore the accelerometer for at least 8 hours on 3 days, including 1 weekend day.	Change from baseline to 6 months
Secondary	Change in Adolescent Moderate to Vigorous Physical Activity From Baseline to 18 Months	Moderate to vigorous physical activity was assessed using an ActiGraph accelerometer worn during waking hours for 7 consecutive days, with the exception of bathing, and swimming. Data were considered valid if they wore the accelerometer for at least 8 hours on 3 days, including 1 weekend day.	Change from baseline to 18 months
Secondary	Change in Parent Physical Activity	Moderate to Vigorous Physical Activity in parents of participants will be assessed at baseline, 3, 6, 12, and 18 months using an ActiGraph accelerometer over 7 days	Change from baseline to 18 months
Secondary	Change in Sedentary Time	Sedentary Time in adolescents with IDD will be assessed at baseline, 3, 6, 12, and 18 months, using an ActiGraph accelerometer over 7 days.	Change from baseline to 18 months
Secondary	Change in Parent Sedentary Time	Sedentary Time in parents of participants will be assessed at baseline, 3, 6, 12, and 18 months, using an ActiGraph accelerometer over 7 days.	Change from baseline to 18 months
Secondary	Change in Cardiovascular Fitness	Cardiovascular fitness will be assessed by treadmill at baseline, 3, 6, 12, and 18 months	Change from baseline to 18 months
Secondary	Change in Muscular Strength	Assessed at baseline, 6, 12, and 18 months by chest press and leg press	Change from baseline to 18 months
Secondary	Change in Motor Ability	Assessed by the Gross Motor Quotient and Percentile obtained from Test of Gross Motor Development-second edition	Change from baseline to 18 months
Secondary	Change in Quality of Life	Assessed a using the PedsQL 4.0 Generic Core Scale designed to measure health-related quality of life in healthy children and adolescents and in those with chronic health conditions	Change from baseline to 18 months