Promotion of Physical Activity in Adolescents With Intellectual and Developmental Disabilities

NCT ID: NCT03684512

Last Updated: 2023-07-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-07

Study Completion Date

2022-10-28

Brief Summary

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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

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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.

Conditions

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Adolescent Behavior Intellectual Disability Down Syndrome Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Group Exercise Sessions

Intervention Type BEHAVIORAL

Remote exercise sessions delivered over group video conference

Individual Support Sessions

Intervention Type BEHAVIORAL

Individual education/support/feedback sessions delivered over video chat

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.

Group Type ACTIVE_COMPARATOR

Group Exercise Sessions

Intervention Type BEHAVIORAL

Remote exercise sessions delivered over group video conference

Individual Support Sessions

Intervention Type BEHAVIORAL

Individual education/support/feedback sessions delivered over video chat

Facebook Group

Intervention Type BEHAVIORAL

Facebook group for parents to provide additional support and education

Interventions

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Group Exercise Sessions

Remote exercise sessions delivered over group video conference

Intervention Type BEHAVIORAL

Individual Support Sessions

Individual education/support/feedback sessions delivered over video chat

Intervention Type BEHAVIORAL

Facebook Group

Facebook group for parents to provide additional support and education

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

University of Kansas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lauren T Ptomey

Role: PRINCIPAL_INVESTIGATOR

University of Kansas

Joseph Donnelly

Role: PRINCIPAL_INVESTIGATOR

University of Kansas

Locations

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University of Kansas

Lawrence, Kansas, United States

Site Status

Countries

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United States

References

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Ptomey LT, Washburn RA, Lee J, Sherman JR, Rice AM, Danon JC, White DA, Szabo-Reed AN, Helsel BC, Donnelly JE. An Individual versus Parent Supported Physical Activity Intervention in Adolescents with Intellectual Disabilities. Med Sci Sports Exerc. 2024 Dec 1;56(12):2256-2266. doi: 10.1249/MSS.0000000000003515. Epub 2024 Jul 4.

Reference Type DERIVED
PMID: 38967389 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31344519 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R01HD094704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00140784

Identifier Type: -

Identifier Source: org_study_id

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