Clinical trial NCT04254666: New Skills - No Scores Research Study
Official title: A Pilot and Feasibility Study to Promote Physical and Food Literacy Among Children With Intellectual Disabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intellectual Disability
Keywords: physical literacy
food literacy
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: University of Massachusetts, Boston
name: Tufts University
First posted: 2020-02-05
Enrollment: 6
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Motivation and Confidence in Physical Activity
timeFrame: Baseline and Post intervention (within 1 month)
measure: Movement/Motor Skills
timeFrame: Baseline and Post intervention (within 1 month)
measure: Desire to Participate in Physical Activity
timeFrame: Baseline and Post intervention (within 1 month)
measure: Healthy Food Knowledge.
timeFrame: Baseline and Post intervention (within 1 month)
measure: Foods Participant is Willing to Eat
timeFrame: Baseline and Post intervention (within 1 month)
measure: Food Categorization
timeFrame: Baseline and Post Intervention (within 1 month)
Secondary outcomes:
measure: Participant (Teen) Enjoyment and Satisfaction
timeFrame: Week 12
measure: Parent Satisfaction
timeFrame: Week 12
measure: Attendance
timeFrame: Weekly for 12 weeks
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Carol Curtin, PhD
role: PRINCIPAL_INVESTIGATOR
References: