Promotion of Physical Activity in Adolescents With Intellectual and Developmental Disabilities

• ClinicalTrials.gov Identifier: NCT03684512
• Recruitment Status: Active, not recruiting
• First Posted: September 25, 2018
• Last Update Posted: April 1, 2021
• Sponsor: University of Kansas
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by (Responsible Party): University of Kansas

Study Description

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 .

Condition or disease	Intervention/treatment	Phase
Adolescent Behavior; Intellectual Disability; Down Syndrome; Physical Activity	Behavioral: Group Exercise Sessions; Behavioral: Individual Support Sessions; Behavioral: Facebook Group	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 116 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Individual and Family-based Approaches to Increase Physical Activity in Adolescents With IDD
• Actual Study Start Date: January 7, 2019
• Estimated Primary Completion Date: October 19, 2021
• Estimated Study Completion Date: October 19, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change in Physical Activity [ Time Frame: Change from baseline to 6 months ]
   Moderate to vigorous physical activity will be assessed at baseline, 3, and 6 months using an ActiGraph accelerometer. Participants will be asked to wear the ActiGraph on a belt over the non-dominant hip at the anterior axillary line during waking hours for 7 consecutive days, with the exception of bathing, and swimming.

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 10 Years to 21 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Kansas

University of Kansas

Lawrence, Kansas, United States, 66045

Sponsors and Collaborators

University of Kansas

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Kansas
• ClinicalTrials.gov Identifier: NCT03684512
• Other Study ID Numbers: STUDY00140784; R01HD094704 ( U.S. NIH Grant/Contract )
• First Posted: September 25, 2018
• Last Update Posted: April 1, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Down Syndrome; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Neurodevelopmental Disorders; Mental Disorders