Promotion of Physical Activity in Adolescents With Intellectual and Developmental Disabilities

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Adolescent Behavior, Intellectual Disability, Down Syndrome, Physical Activity

Intervention / Treatment
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* Behavioral: Group Exercise Sessions
* Behavioral: Individual Support Sessions
* Behavioral: Facebook Group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adolescent Only<br>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<br>* Remote exercise sessions delivered over group video conference<br>Behavioral: Individual Support Sessions<br>* Individual education/support/feedback sessions delivered over video chat<br>|
| Active Comparator: Adolescent and Parent<br>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<br>* Remote exercise sessions delivered over group video conference<br>Behavioral: Individual Support Sessions<br>* Individual education/support/feedback sessions delivered over video chat<br>Behavioral: Facebook Group<br>* Facebook group for parents to provide additional support and education<br>|

What is the study measuring?
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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 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 | 
| 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 |