Promotion of Physical Activity in Adolescents With Intellectual and Developmental Disabilities

Kansas Board of Regents

Status: Completed

Conditions: Physical Activity; Down Syndrome; Intellectual Disability; Adolescent Behavior

Treatments: Behavioral: Individual Support Sessions; Behavioral: Group Exercise Sessions; Behavioral: Facebook Group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03684512

STUDY00140784

R01HD094704 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 10 to 21 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

116 participants in 2 patient groups

Adolescent Only

Experimental group

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.

Treatment:

Behavioral: Individual Support Sessions

Behavioral: Group Exercise Sessions

Adolescent and Parent

Active Comparator group

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.

Treatment:

Behavioral: Facebook Group

Behavioral: Individual Support Sessions

Behavioral: Group Exercise Sessions