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New Skills - No Scores Research Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04254666
Recruitment Status : Suspended (The COVID-19 pandemic required that we discontinue the study.)
First Posted : February 5, 2020
Last Update Posted : September 4, 2020
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Massachusetts, Boston
Tufts University
Information provided by (Responsible Party):
Carol Curtin, PhD, University of Massachusetts, Worcester

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.

Condition or disease Intervention/treatment Phase
Intellectual Disability Behavioral: Physical Literacy & Food Literacy Intervention. Not Applicable

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 combined sport sampling and healthy eating education program. Weekly sessions will include 60 minutes of sports activities and 45 minutes of educational and skill activities to promote healthy eating. Sport sampling activities will aim to develop locomotor and object control skills via 3 sports: soccer, basketball, and Run-Jump-Throw. 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 an at-home component called "Bring it Home, Give it Try." Children will be provided with a piece(s) of sports equipment (e.g., soccer ball, jump rope) and skill cards with instructions and fun ideas for practicing sport skills outside of program sessions, and will be provided recipes related to the weekly taste test to promote healthy eating at home. The pilot intervention will be delivered in 2 waves of 15 participants each at YMCAs/Boys & Girls Clubs in eastern/central MA. 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 Canadian Agility and Movement Skill Assessment, 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 of food knowledge, a test of rudimentary food preparation skills, 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Pilot and Feasibility Study to Promote Physical and Food Literacy Among Children With Intellectual Disabilities
Actual Study Start Date : January 24, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Physical Literacy & Food Literacy Intervention
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.
Behavioral: Physical Literacy & Food Literacy Intervention.
A 12-week intervention designed to expose adolescents with ID to a variety of sports and healthy eating concepts to equip them with skills and confidence to participate in physical activities 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 90 minutes at a Boys & Girls Club after school; 60 minutes will focus on sport activities with 45 minutes devoted to healthy eating.
Other Name: New Skills - No Scores




Primary Outcome Measures :
  1. Physical Self Concept [ Time Frame: Baseline and Post intervention (within 1 month) ]
    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.

  2. Movement Skills [ Time Frame: Baseline and Post intervention (within 1 month) ]
    Will be measured with the Canadian Agility and Movement Skill Assessment (CAMSA). The CAMSA requires participants to travel a distance of 20 m in a movement/agility course while completing 7 different movement skills in succession. Performance on the CAMSA is evaluated using an aggregate of time to complete the course and the quality of skills performed based on established criteria. Time is converted to a predefined point score (range 1-14), and the quality of each skill is scored as either performed (score of 1) or not (score of 0) (range 0-14). Thus, the total score which is time and skill combined has a range of 1-28; higher scores connote higher motor skill/ability.We will examine changes in participants' motor skills between baseline and post-intervention.

  3. Desire to participate in physical activity [ Time Frame: Baseline and Post intervention (within 1 month) ]
    Will be measured via 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). The CAPL-2 Questionnaire subscale will be verbally administered. Total scores will range from 0-6 with an item response assigned 0 or 1. Higher scores indicate higher self-perception and higher predilection for engagement in physical activity. We will examine changes in participants' desire to participate in physical activity between baseline and post-intervention.

  4. Food Knowledge and Skills [ Time Frame: Baseline and Post intervention (within 1 month) ]
    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.

  5. Healthy eating (dietary) behavior [ Time Frame: Baseline and Post intervention (within 1 month) ]
    Will be measured by parent proxy using the dietary assessment questions asked as part of the Youth Risk Behavioral Surveillance Survey. There are a 9 questions related to dietary intake, yielding the frequency with which foods were eaten in the past 7 days (range: 0 to 4+ times per day).We will examine changes in participants' dietary behavior between baseline and post-intervention.

  6. Food Frequency Questionnaire (FFQ) [ Time Frame: Baseline and Post intervention (within 1 month) ]
    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 :
  1. Participant enjoyment and satisfaction [ Time Frame: Week 6 and 12 ]
    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.

  2. Parent satisfaction [ Time Frame: Week 6 and 12 ]
    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.

  3. Attendance [ Time Frame: Weekly for 12 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04254666


Locations
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United States, Massachusetts
Woburn Boys & Girls Club
Woburn, Massachusetts, United States, 01801
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Massachusetts, Boston
Tufts University
Investigators
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Principal Investigator: Carol Curtin, PhD University of Massachusetts, Worcester
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Responsible Party: Carol Curtin, PhD, Associate Professor, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT04254666    
Other Study ID Numbers: H00017816
1R21HD099435-01 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to share data from this pilot project.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carol Curtin, PhD, University of Massachusetts, Worcester:
physical literacy
food literacy
Additional relevant MeSH terms:
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Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurodevelopmental Disorders
Mental Disorders