Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2025-12-24 @ 4:03 PM
Study NCT ID:
NCT04254666
Status:
COMPLETED
Last Update Posted:
2023-12-13
First Post:
2020-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
New Skills - No Scores Research Study
Sponsor:
University of Massachusetts, Worcester
Organization:
Study Overview
Official Title:
A Pilot and Feasibility Study to Promote Physical and Food Literacy Among Children With Intellectual Disabilities
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
Children with intellectual disabilities (ID) are more likely than typically developing children to have higher cardio-metabolic risk factors, lower levels of health-related fitness, and be overweight and obese. As such, they represent a health disparities population. Low physical activity levels, increased sedentary time, and poor diet quality are likely contributors to these inequities. The goal of the Investigators is to develop strategies that enable children with ID to attain optimal health by meeting US Physical Activity Guidelines and Dietary Guidelines for Americans. To achieve this goal, children with ID must develop physical literacy and food literacy - the knowledge, skills, confidence and desire to participate in physical activity and make healthy food choices. This project seeks to:1) test the feasibility of a physical literacy and food literacy intervention for children with ID, and 2) preliminarily assess the efficacy of the intervention for increasing physical literacy including movement skills, confidence, and desire to participate in physical activity, and food literacy including knowledge around making healthy food choices, basic food preparation skills, and engaging in healthy eating behavior. Thirty male (n=15) and female (n=15) children with ID ages 12-16 will participate in a 12-week , virtual, combined sport skills sampling and healthy eating education program. Weekly online sessions will include 35 minutes of sports skills activities and 35 minutes of educational and skill activities to promote healthy eating. Sport skill sampling activities will aim to develop locomotor and object control skills via four 3-week sessions including dribbling, locomotor skills, ball skills, and a fourth session combining them all. Healthy eating sessions will focus on increasing knowledge to identify healthy foods and to make healthy choices, basic skills for preparing food, and a taste test thematically related to the lesson. The intervention will also include a practice component called "Give it Try." Children will be provided with a piece(s) of sports equipment (e.g., soccer ball, basketball) and skill videos with instructions and fun ideas for practicing sport skills outside of program sessions, additionally as part of "Give it a Try" we encourage participants to try new foods outside of the intervention. Process measures of demand, acceptability, and implementation will be obtained to test feasibility, and a pre-test/post-test design will allow for preliminary data on efficacy of the intervention. Measures of physical literacy include the Test of Gross Motor Development, 3rd ed, Physical Self-Inventory-ID, and Children's Self- Perceptions of Adequacy in and Predilection for Physical Activity scale. Measures of food literacy include a questionnaire on food knowledge and parent proxy report of dietary patterns based on a modified food frequency questionnaire (FFQ), and questions from the Youth Risk Behavioral Surveillance Survey. This early phase study is a step toward promoting health and reducing the inequities that exist for children with ID.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R21HD099435-01 | NIH | None | https://reporter.nih.gov/quic… | View |