Promotion of Physical Activity in Adolescents With Intellectual and Developmental Disabilities

Not Applicable

Completed

Conditions: Physical Activity
Adolescent Behavior
Down Syndrome
Intellectual Disability

Interventions: Behavioral: Group Exercise Sessions
Behavioral: Individual Support Sessions
Behavioral: Facebook Group

Registration Number: NCT03684512

Lead Sponsor: University of Kansas

Brief 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 .

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 116

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adolescent Only	Individual Support Sessions	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.
Adolescent and Parent	Group Exercise Sessions	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.
Adolescent and Parent	Facebook Group	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.
Adolescent and Parent	Individual Support Sessions	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.
Adolescent Only	Group Exercise Sessions	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.

Primary Outcome Measures

Name	Time	Method
Change in Adolescent Physical Activity From Baseline to 6 Months	Change 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.

Secondary Outcome Measures

Name	Time	Method
Change in Adolescent Moderate to Vigorous Physical Activity From Baseline to 18 Months	Change 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 in Quality of Life	Change from baseline to 18 months	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 in Parent Sedentary Time	Change from baseline to 18 months	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 in Muscular Strength	Change from baseline to 18 months	Assessed at baseline, 6, 12, and 18 months by chest press and leg press
Change in Cardiovascular Fitness	Change from baseline to 18 months	Cardiovascular fitness will be assessed by treadmill at baseline, 3, 6, 12, and 18 months
Change in Motor Ability	Change from baseline to 18 months	Assessed by the Gross Motor Quotient and Percentile obtained from Test of Gross Motor Development-second edition
Change in Parent Physical Activity	Change from baseline to 18 months	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 in Sedentary Time	Change from baseline to 18 months	Sedentary Time in adolescents with IDD will be assessed at baseline, 3, 6, 12, and 18 months, using an ActiGraph accelerometer over 7 days.