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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 : Recruiting
First Posted : September 25, 2018
Last Update Posted : January 18, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Kansas

Tracking Information
First Submitted Date  ICMJE September 24, 2018
First Posted Date  ICMJE September 25, 2018
Last Update Posted Date January 18, 2019
Actual Study Start Date  ICMJE January 7, 2019
Estimated Primary Completion Date July 24, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03684512 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2018)
  • 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
  • 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
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Promotion of Physical Activity in Adolescents With Intellectual and Developmental Disabilities
Official Title  ICMJE Individual and Family-based Approaches to Increase Physical Activity in Adolescents With IDD
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Adolescent Behavior
  • Intellectual Disability
  • Down Syndrome
  • Physical Activity
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: Group Exercise Sessions
    • Behavioral: Individual Support Sessions
  • 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.
    Interventions:
    • Behavioral: Group Exercise Sessions
    • Behavioral: Individual Support Sessions
    • Behavioral: Facebook Group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 24, 2018)
114
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 24, 2023
Estimated Primary Completion Date July 24, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lauren Ptomey 913-588-7983 lptomey@ku.edu
Contact: Joseph E Donnelly 785-864-3880 jdonnelly@ku.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03684512
Other Study ID Numbers  ICMJE STUDY00140784
R01HD094704 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Kansas
Study Sponsor  ICMJE University of Kansas
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Lauren T Ptomey University of Kansas
Principal Investigator: Joseph Donnelly University of Kansas
PRS Account University of Kansas
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP