Promotion of Physical Activity in Adolescents With Intellectual and Developmental Disabilities

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

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 .

Study Overview

• Status: Completed
• Conditions: Physical Activity; Intellectual Disability; Down Syndrome; Adolescent Behavior
• Intervention / Treatment: Behavioral: Group Exercise Sessions; Behavioral: Individual Support Sessions; Behavioral: Facebook Group

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lawrence, Kansas, United States, 66045
      • University of Kansas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adolescent Only; Remote based physical activity intervention delivered to adolescents only. Adolescents will be asked to attend weekly group exercise sessions, individual support sessions, and monitor their daily physical activity.	Behavioral: Group Exercise Sessions; Remote exercise sessions delivered over group video conference; Behavioral: Individual Support Sessions; Individual education/support/feedback sessions delivered over video chat
Active Comparator: Adolescent and Parent; Remote based physical activity intervention delivered to adolescents and their parent. Adolescents and a parent will be asked to attend weekly group exercise sessions, individual support sessions, and monitor their daily physical activity. Parents will have access to a Parent Facebook group.	Behavioral: Group Exercise Sessions; Remote exercise sessions delivered over group video conference; Behavioral: Individual Support Sessions; Individual education/support/feedback sessions delivered over video chat; Behavioral: Facebook Group; Facebook group for parents to provide additional support and education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Change in Muscular Strength	Assessed at baseline, 6, 12, and 18 months by chest press and leg press	Change from baseline to 18 months
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
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
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

Collaborators and Investigators

• Sponsor: University of Kansas
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Lauren T Ptomey, University of Kansas; Principal Investigator: Joseph Donnelly, University of Kansas

Publications and helpful links

General Publications

• Ptomey LT, Washburn RA, Lee J, Greene JL, Szabo-Reed AN, Sherman JR, Danon JC, Osborne LN, Little TD, Donnelly JE. Individual and family-based approaches to increase physical activity in adolescents with intellectual and developmental disabilities: Rationale and design for an 18 month randomized trial. Contemp Clin Trials. 2019 Sep;84:105817. doi: 10.1016/j.cct.2019.105817. Epub 2019 Jul 22.

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2019
• Primary Completion (Actual): October 29, 2021
• Study Completion (Actual): October 28, 2022

Study Registration Dates

• First Submitted: September 24, 2018
• First Submitted That Met QC Criteria: September 24, 2018
• First Posted (Actual): September 25, 2018

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 30, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Congenital Abnormalities; Genetic Diseases, Inborn; Neurodevelopmental Disorders; Abnormalities, Multiple; Chromosome Disorders; Down Syndrome; Intellectual Disability
• Other Study ID Numbers: STUDY00140784; R01HD094704 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No