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Completed

NCT Number: NCT03684512

Promotion of Physical Activity in Adolescents With Intellectual and Developmental Disabilities

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 .

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Key information

Conditions

Adolescent Behavior Abnormalities, Multiple Behavior Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Down Syndrome Genetic Diseases, Inborn Intellectual Disability Mental Disorders Motor Activity Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Physical Activity Signs and Symptoms

Age range

10 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas

Lawrence, Kansas, 66045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group Exercise Sessions

Behavioral

Remote exercise sessions delivered over group video conference

Individual Support Sessions

Behavioral

Individual education/support/feedback sessions delivered over video chat

Facebook Group

Behavioral

Facebook group for parents to provide additional support and education

Primary outcomes

  1. Change in Adolescent Physical Activity From Baseline to 6 Months

    Time frame: 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 outcomes

  1. Change in Adolescent Moderate to Vigorous Physical Activity From Baseline to 18 Months

    Time frame: 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.

  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

Sponsors and collaborators

Lead sponsor

University of Kansas

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Sep 25, 2018
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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