Clinical trial NCT03684512: 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
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Behavior
Intellectual Disability
Down Syndrome
Physical Activity
Lead sponsor: University of Kansas
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-09-25
Enrollment: 116
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change in Adolescent Physical Activity From Baseline to 6 Months
timeFrame: Change from baseline to 6 months
Secondary outcomes:
measure: Change in Adolescent Moderate to Vigorous Physical Activity From Baseline to 18 Months
timeFrame: Change from baseline to 18 months
measure: Change in Parent Physical Activity
timeFrame: Change from baseline to 18 months
measure: Change in Sedentary Time
timeFrame: Change from baseline to 18 months
measure: Change in Parent Sedentary Time
timeFrame: Change from baseline to 18 months
measure: Change in Cardiovascular Fitness
timeFrame: Change from baseline to 18 months
measure: Change in Muscular Strength
timeFrame: Change from baseline to 18 months
measure: Change in Motor Ability
timeFrame: Change from baseline to 18 months
measure: Change in Quality of Life
timeFrame: Change from baseline to 18 months
Other outcomes:
Locations:
city: Lawrence
country: United States
facility: University of Kansas
state: Kansas
Study officials:
affiliation: University of Kansas
name: Lauren T Ptomey
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kansas
name: Joseph Donnelly
role: PRINCIPAL_INVESTIGATOR
References:
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.