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Promotion of Physical Activity in Adolescents With Intellectual and Developmental Disabilities

Primary Purpose

Adolescent Behavior, Intellectual Disability, Down Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Exercise Sessions
Individual Support Sessions
Facebook Group
Sponsored by
University of Kansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adolescent Behavior

Eligibility Criteria

10 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Kansas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adolescent Only

Adolescent and Parent

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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 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 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 in Cardiovascular Fitness
Cardiovascular fitness will be assessed by treadmill at baseline, 3, 6, 12, and 18 months
Change in Muscular Strength
Assessed at baseline, 6, 12, and 18 months by chest press and leg press
Change in Motor Ability
Assessed by the Gross Motor Quotient and Percentile obtained from Test of Gross Motor Development-second edition
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

Full Information

First Posted
September 24, 2018
Last Updated
June 30, 2023
Sponsor
University of Kansas
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03684512
Brief Title
Promotion of Physical Activity in Adolescents With Intellectual and Developmental Disabilities
Official Title
Individual and Family-based Approaches to Increase Physical Activity in Adolescents With IDD
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
October 29, 2021 (Actual)
Study Completion Date
October 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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 .
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Behavior, Intellectual Disability, Down Syndrome, Physical Activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adolescent Only
Arm Type
Experimental
Arm Description
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.
Arm Title
Adolescent and Parent
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group Exercise Sessions
Intervention Description
Remote exercise sessions delivered over group video conference
Intervention Type
Behavioral
Intervention Name(s)
Individual Support Sessions
Intervention Description
Individual education/support/feedback sessions delivered over video chat
Intervention Type
Behavioral
Intervention Name(s)
Facebook Group
Intervention Description
Facebook group for parents to provide additional support and education
Primary Outcome Measure Information:
Title
Change in Adolescent Physical Activity From Baseline to 6 Months
Description
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.
Time Frame
Change from baseline to 6 months
Secondary Outcome Measure Information:
Title
Change in Adolescent Moderate to Vigorous Physical Activity From Baseline to 18 Months
Description
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.
Time Frame
Change from baseline to 18 months
Title
Change in Parent Physical Activity
Description
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
Time Frame
Change from baseline to 18 months
Title
Change in Sedentary Time
Description
Sedentary Time in adolescents with IDD will be assessed at baseline, 3, 6, 12, and 18 months, using an ActiGraph accelerometer over 7 days.
Time Frame
Change from baseline to 18 months
Title
Change in Parent Sedentary Time
Description
Sedentary Time in parents of participants will be assessed at baseline, 3, 6, 12, and 18 months, using an ActiGraph accelerometer over 7 days.
Time Frame
Change from baseline to 18 months
Title
Change in Cardiovascular Fitness
Description
Cardiovascular fitness will be assessed by treadmill at baseline, 3, 6, 12, and 18 months
Time Frame
Change from baseline to 18 months
Title
Change in Muscular Strength
Description
Assessed at baseline, 6, 12, and 18 months by chest press and leg press
Time Frame
Change from baseline to 18 months
Title
Change in Motor Ability
Description
Assessed by the Gross Motor Quotient and Percentile obtained from Test of Gross Motor Development-second edition
Time Frame
Change from baseline to 18 months
Title
Change in Quality of Life
Description
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
Time Frame
Change from baseline to 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren T Ptomey
Organizational Affiliation
University of Kansas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph Donnelly
Organizational Affiliation
University of Kansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31344519
Citation
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.
Results Reference
derived

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Promotion of Physical Activity in Adolescents With Intellectual and Developmental Disabilities

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