N/A
Completed N=6
New Skills - No Scores Research Study
Source: ClinicalTrials.gov NCT04254666 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcomePrimary: Motivation and Confidence in Physical Activity — 3.42; 3.42; 3.17; 3.42 score on a scale
Summary
The purpose of this study is to test the feasibility of a physical literacy and food literacy intervention for children with Intellectual Disabilities ages 12-16 years. The Investigators plan to assess preliminary efficacy of the intervention for increasing 1) physical literacy including movement skills, physical self-concept, and desire to participate in physical activity and 2) food literacy including knowledge around making healthy food choices, basic food preparation skills, and engaging in healthy eating behavior.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Motivation and Confidence in Physical Activity |
3.42; 3.42; 3.17; 3.42; 2.50; 2.75 | — |
| PRIMARY Movement/Motor Skills |
24.0; 27.8; 7.8; 7.7; 2.17; 2.5 | — |
| PRIMARY Desire to Participate in Physical Activity |
1.5; 2.67; 2.0; 2.67; 4.17; 4.67 | — |
| PRIMARY Healthy Food Knowledge. |
3.17; 3.33; 1.5; 1.83; 1.33; 1.83 | — |
| PRIMARY Foods Participant is Willing to Eat |
20.83; 23.5; 16.17; 17.00; 13.83; 14.83 | — |
| PRIMARY Food Categorization |
64.7; 79.3 | — |
| SECONDARY Participant (Teen) Enjoyment and Satisfaction |
100; 50; 83; 83; 100; 83 | — |
| SECONDARY Parent Satisfaction |
83; 50; 83; 83 | — |
| SECONDARY Attendance |
87.5 | — |
Eligibility Criteria
Inclusion Criteria
- measured IQ and adaptive functioning scores of ≤75 as measured by the Kaufman Brief Intelligence Test-2 (KBIT-2) and Vineland Adaptive Behavior Scales-III (VABS-III). A score > 75 for participants that do not have a syndrome that is associated with ID will be exclusionary. However, participants with such syndromes (e.g., Down syndrome) may have scores above this cut-point but are still classified as having an intellectual disability and thus will qualify for the study.
- Participants must be ambulatory and in sufficiently good health to engage in moderate-to-vigorous physical activity
- able to communicate verbally in English, follow simple instructions, and provide assent.
- approval from the participants' primary care physician and specialists (as necessary) will be required for participation.
Exclusion Criteria
- uncontrolled medical or significant psychiatric condition
- insulin-dependent diabetes
- physical/orthopedic impairment that would preclude participation in physical activity
- legally blind or deaf
- habitual problem behaviors such as aggression, noncompliance, or leaving an activity area.
Data sourced from ClinicalTrials.gov (NCT04254666). 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.