N/A
Completed N=116
Promotion of Physical Activity in Adolescents With Intellectual and Developmental Disabilities
Adolescent Behavior · Intellectual Disability · Down Syndrome · Physical Activity
Source: ClinicalTrials.gov NCT03684512 ↗
Enrolled (actual)
116
Serious AEs
2.6%
Results posted
Jul 2023
Primary outcomePrimary: Change in Adolescent Physical Activity From Baseline to 6 Months — -3.2; -0.6 minutes per day
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 .
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Adolescent Physical Activity From Baseline to 6 Months |
-3.2; -0.6 | — |
| SECONDARY Change in Adolescent Moderate to Vigorous Physical Activity From Baseline to 18 Months |
-1.5; 7.6 | — |
| SECONDARY Change in Parent Physical Activity |
— | — |
| SECONDARY Change in Sedentary Time |
— | — |
| SECONDARY Change in Parent Sedentary Time |
— | — |
| SECONDARY Change in Cardiovascular Fitness |
— | — |
| SECONDARY Change in Muscular Strength |
— | — |
| SECONDARY Change in Motor Ability |
— | — |
| SECONDARY Change in Quality of Life |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT03684512). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.