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Promotion of Physical Activity in Adolescents With Intellectual and Developmental Disabilities

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ClinicalTrials.gov Identifier: NCT03684512
Recruitment Status : Not yet recruiting
First Posted : September 25, 2018
Last Update Posted : September 25, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
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 .

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 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
Estimated Study Start Date : January 25, 2019
Estimated Primary Completion Date : July 24, 2022
Estimated Study Completion Date : January 24, 2023


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




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



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Ages Eligible for Study:   10 Years to 19 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03684512


Contacts
Contact: Lauren Ptomey 913-588-7983 lptomey@ku.edu
Contact: Joseph E Donnelly 785-864-3880 jdonnelly@ku.edu

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

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT03684512     History of Changes
Other Study ID Numbers: STUDY00140784
R01HD094704 ( U.S. NIH Grant/Contract )
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
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
Developmental Disabilities
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders