N/A
N=6
New Skills - No Scores Research Study
Intellectual Disability
Bottom Line
View on ClinicalTrials.gov: NCT04254666 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Motivation and Confidence in Physical Activity — 3.42; 3.42; 3.17; 3.42 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Physical Literacy & Food Literacy Intervention. (Behavioral)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- University of Massachusetts, Worcester
- Primary completion
- Aug 2022
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 | — |
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.
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.