Promotion of Physical Activity in Adolescents With Intellectual and Developmental Disabilities

NCT03684512 | Completed Results

• 2 other identifiers: STUDY00140784R01HD094704
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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 .

Conditions

Adolescent Behavior; Intellectual Disability; Down Syndrome; Physical Activity

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline to 6 months

Secondary Outcomes (8)

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

  Change from baseline to 18 months

• Change in Parent Physical Activity

  Change from baseline to 18 months

• Change in Sedentary Time

  Change from baseline to 18 months

• Change in Parent Sedentary Time

  Change from baseline to 18 months

• Change in Cardiovascular Fitness

  Change from baseline to 18 months

Study Arms (2)

Adolescent Only

EXPERIMENTAL

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.

Behavioral: Group Exercise Sessions; Behavioral: Individual Support Sessions

Adolescent and Parent

ACTIVE COMPARATOR

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.

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

Interventions

Group Exercise Sessions BEHAVIORAL

Remote exercise sessions delivered over group video conference

Adolescent Only; Adolescent and Parent

Individual Support Sessions BEHAVIORAL

Individual education/support/feedback sessions delivered over video chat

Adolescent Only; Adolescent and Parent

Facebook Group BEHAVIORAL

Facebook group for parents to provide additional support and education

Adolescent and Parent

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Kansas

Lawrence, Kansas, 66045, United States

Location

Related Publications (2)

• 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.

  PMID: 38967389 DERIVED

• 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.

  PMID: 31344519 DERIVED

MeSH Terms

Conditions

Adolescent Behavior; Intellectual Disability; Down Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Results Point of Contact

• Title: Dr. Lauren Ptomey
• Organization: University of Kansas Medical Center

lptomey@kumc.edu

913-588-7983

Study Officials

• Lauren T Ptomey

  University of Kansas

  PRINCIPAL INVESTIGATOR

• Joseph Donnelly

  University of Kansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: September 25, 2018
• Study Start: January 7, 2019
• Primary Completion: October 29, 2021
• Study Completion: October 28, 2022
• Last Updated: July 3, 2023
• Results First Posted: July 3, 2023

Record last verified: 2023-06

Locations

US (1)