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New Skills - No Scores Research Study

Primary Purpose

Intellectual Disability

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Literacy & Food Literacy Intervention.
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Intellectual Disability focused on measuring physical literacy, food literacy

Eligibility Criteria

12 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Massachusetts Medical School

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Physical Literacy & Food Literacy Intervention

Arm Description

This is a pilot project to assess the feasibility of a physical literacy and food literacy intervention for adolescents with ID ages 12-16 years.

Outcomes

Primary Outcome Measures

Motivation and Confidence in Physical Activity
Physical Self-Concept will be measured using the Very Short Form of the Physical Self-Inventory-Intellectual Disability (PSI-VSF-ID). The PSI-VSF-ID is a 12-item questionnaire that measures six dimensions of self-concept: 1) Global Self-Concept; 2) Physical Self-Worth; 3) Sport Competence; 4) Physical Attractiveness; 5) Physical Condition; and 6) Physical Strength. Four response options range from "very true" to "not at all true", and a visual answer scale uses smiling/frowning faces effective for use with adolescents with ID. Higher scores indicate higher self-concept in the aforementioned domains. We will examine changes in participants' physical self-concept between baseline and post-intervention.
Movement/Motor Skills
Movement/Motor Skills will be assessed using the Test of Gross Motor Development (3rd ed). The TGMD-3 assesses 13 fundamental motor skills related to 1) locomotor skills and 2) ball skills. The TGMD-3 is a direct observation skill assessment with 3-5 performance criteria for each skill. We will assess: skipping, two-foot jumping, one-foot hopping, sideways sliding, overhand throw, underhand throw, catch, hand dribble, and kick. The TGMD-3 will be administered via Zoom at baseline and post-12 weeks. A trained tester will provide verbal instructions and demonstrations for each skill during the session. Additionally, instructional videos for each TGMD skill will be provided to the participants and parents in advance for them to review and practice before the testing session. It should take approximately 30-40 minutes to administer. A trained professional will review and code the video-recorded TGMD-3 performance on each skill and provide a score at baseline and post-test.
Desire to participate in physical activity
The adequacy and predilection for physical activity subscale of the Canadian Assessment of Physical Literacy - Second Edition (CAPL-2) Questionnaire will estimate the participant's desire to participate in physical activity. The 6-item questionnaire subscale includes 3 items that assess perceived adequacy (i.e., self-perception that one has the capability to achieve an acceptable standard of success conceptualized by the self and others) and 3 items that assess perceived predilection for physical activity (i.e., likelihood of selecting physical activity over sedentary behavior when given the choice). This shortened and refined version of the original CAPL Questionnaire is underpinned by self-determination theory which is often used to understand motivation and perceived competence (Gunnell et al., 2018). The adequacy and predilection subscale, called "What's Most Like Me?", uses an alternative response choice format to present statements about preferences and feelings about physical
Healthy Food Knowledge.
Will be measured with a hands-on Food Knowledge/Skills test adapted from knowledge tests for typically developing children and children with ID developed by the investigative team. Participants will be asked to classify individual foods into food groups (e.g., an apple belongs in the fruit group), and other healthy eating concepts such as identifying whole grains, choosing the healthiest meal between two pictures of plates with food on them, and identifying beverages that have less sugar. For each item, answers will be scored as correct or incorrect (0 or 1) or "I don't know" (0) and summed for a total of percent correct. We will examine changes in participants' food knowledge/skills between baseline and post-intervention.
Healthy eating (dietary) behavior
This pictorial-based knowledge assessment will be based on the content of the food literacy curriculum. We will provide participants with pictures of 25 different foods and ask them to classify them by the correct food group. We will do qualitative probes to understand why/how the participant selected their response. Participants will also be asked to identify the healthiest beverage and healthiest meal from a set of pictures presented to them.
Food Frequency Questionnaire (FFQ)
We will administer a modified food frequency questionnaire (FFQ) that we have developed for other studies that contains lists of foods organized by food group. Parents will be asked to indicate which foods their teen eats, which foods their teen will not eat, and whether any of the foods are never served to the teen. There is also a single question that asks parents to indicate how willing their teen is to try new foods. The FFQ will allow us to assess whether the teen's willingness to try new foods changes as a result of the intervention and whether there is an increase in the proportion of foods of the total that they consume post-intervention compared to baseline.

Secondary Outcome Measures

Participant enjoyment and satisfaction
Will be measured with a survey of enjoyment, satisfaction, and perceived appropriateness of key elements of the program. Survey will include closed-ended questions with Likert scale response categories, and will be verbally administered.
Parent satisfaction
Will be measured with a survey of satisfaction and perceptions of the program that queries key elements of the program. Survey will include closed-ended questions with Likert scale response categories, and space for open-ended comments and feedback.
Attendance
Attendance will be recorded at each weekly session of the 12-week intervention. Absences and withdrawals will be documented. We will determine the proportion (%) of sessions attended by each participant.

Full Information

First Posted
January 29, 2020
Last Updated
September 26, 2022
Sponsor
University of Massachusetts, Worcester
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Massachusetts, Boston, Tufts University
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1. Study Identification

Unique Protocol Identification Number
NCT04254666
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 24, 2020 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Massachusetts, Boston, Tufts University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intellectual Disability
Keywords
physical literacy, food literacy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical Literacy & Food Literacy Intervention
Arm Type
Other
Arm Description
This is a pilot project to assess the feasibility of a physical literacy and food literacy intervention for adolescents with ID ages 12-16 years.
Intervention Type
Behavioral
Intervention Name(s)
Physical Literacy & Food Literacy Intervention.
Other Intervention Name(s)
New Skills - No Scores
Intervention Description
A 12-week intervention designed to expose adolescents with ID to a variety of sports skills and healthy eating concepts to equip them with skills and confidence to participate in sports and make healthy food choices. The program will follow a protocol adapted to meet the needs of a diverse group of children with ID. Sessions will be held 1 time/week for 75 minutes virtually; 35 minutes will focus on sport skills activities with 35 minutes devoted to healthy eating.
Primary Outcome Measure Information:
Title
Motivation and Confidence in Physical Activity
Description
Physical Self-Concept will be measured using the Very Short Form of the Physical Self-Inventory-Intellectual Disability (PSI-VSF-ID). The PSI-VSF-ID is a 12-item questionnaire that measures six dimensions of self-concept: 1) Global Self-Concept; 2) Physical Self-Worth; 3) Sport Competence; 4) Physical Attractiveness; 5) Physical Condition; and 6) Physical Strength. Four response options range from "very true" to "not at all true", and a visual answer scale uses smiling/frowning faces effective for use with adolescents with ID. Higher scores indicate higher self-concept in the aforementioned domains. We will examine changes in participants' physical self-concept between baseline and post-intervention.
Time Frame
Baseline and Post intervention (within 1 month)
Title
Movement/Motor Skills
Description
Movement/Motor Skills will be assessed using the Test of Gross Motor Development (3rd ed). The TGMD-3 assesses 13 fundamental motor skills related to 1) locomotor skills and 2) ball skills. The TGMD-3 is a direct observation skill assessment with 3-5 performance criteria for each skill. We will assess: skipping, two-foot jumping, one-foot hopping, sideways sliding, overhand throw, underhand throw, catch, hand dribble, and kick. The TGMD-3 will be administered via Zoom at baseline and post-12 weeks. A trained tester will provide verbal instructions and demonstrations for each skill during the session. Additionally, instructional videos for each TGMD skill will be provided to the participants and parents in advance for them to review and practice before the testing session. It should take approximately 30-40 minutes to administer. A trained professional will review and code the video-recorded TGMD-3 performance on each skill and provide a score at baseline and post-test.
Time Frame
Baseline and Post intervention (within 1 month)
Title
Desire to participate in physical activity
Description
The adequacy and predilection for physical activity subscale of the Canadian Assessment of Physical Literacy - Second Edition (CAPL-2) Questionnaire will estimate the participant's desire to participate in physical activity. The 6-item questionnaire subscale includes 3 items that assess perceived adequacy (i.e., self-perception that one has the capability to achieve an acceptable standard of success conceptualized by the self and others) and 3 items that assess perceived predilection for physical activity (i.e., likelihood of selecting physical activity over sedentary behavior when given the choice). This shortened and refined version of the original CAPL Questionnaire is underpinned by self-determination theory which is often used to understand motivation and perceived competence (Gunnell et al., 2018). The adequacy and predilection subscale, called "What's Most Like Me?", uses an alternative response choice format to present statements about preferences and feelings about physical
Time Frame
Baseline and Post intervention (within 1 month)
Title
Healthy Food Knowledge.
Description
Will be measured with a hands-on Food Knowledge/Skills test adapted from knowledge tests for typically developing children and children with ID developed by the investigative team. Participants will be asked to classify individual foods into food groups (e.g., an apple belongs in the fruit group), and other healthy eating concepts such as identifying whole grains, choosing the healthiest meal between two pictures of plates with food on them, and identifying beverages that have less sugar. For each item, answers will be scored as correct or incorrect (0 or 1) or "I don't know" (0) and summed for a total of percent correct. We will examine changes in participants' food knowledge/skills between baseline and post-intervention.
Time Frame
Baseline and Post intervention (within 1 month)
Title
Healthy eating (dietary) behavior
Description
This pictorial-based knowledge assessment will be based on the content of the food literacy curriculum. We will provide participants with pictures of 25 different foods and ask them to classify them by the correct food group. We will do qualitative probes to understand why/how the participant selected their response. Participants will also be asked to identify the healthiest beverage and healthiest meal from a set of pictures presented to them.
Time Frame
Baseline and Post intervention (within 1 month)
Title
Food Frequency Questionnaire (FFQ)
Description
We will administer a modified food frequency questionnaire (FFQ) that we have developed for other studies that contains lists of foods organized by food group. Parents will be asked to indicate which foods their teen eats, which foods their teen will not eat, and whether any of the foods are never served to the teen. There is also a single question that asks parents to indicate how willing their teen is to try new foods. The FFQ will allow us to assess whether the teen's willingness to try new foods changes as a result of the intervention and whether there is an increase in the proportion of foods of the total that they consume post-intervention compared to baseline.
Time Frame
Baseline and Post intervention (within 1 month)
Secondary Outcome Measure Information:
Title
Participant enjoyment and satisfaction
Description
Will be measured with a survey of enjoyment, satisfaction, and perceived appropriateness of key elements of the program. Survey will include closed-ended questions with Likert scale response categories, and will be verbally administered.
Time Frame
Week 6 and 12
Title
Parent satisfaction
Description
Will be measured with a survey of satisfaction and perceptions of the program that queries key elements of the program. Survey will include closed-ended questions with Likert scale response categories, and space for open-ended comments and feedback.
Time Frame
Week 6 and 12
Title
Attendance
Description
Attendance will be recorded at each weekly session of the 12-week intervention. Absences and withdrawals will be documented. We will determine the proportion (%) of sessions attended by each participant.
Time Frame
Weekly for 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol Curtin, PhD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan to share data from this pilot project.

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New Skills - No Scores Research Study

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