- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04254666
New Skills - No Scores Research Study
A Pilot and Feasibility Study to Promote Physical and Food Literacy Among Children With Intellectual Disabilities
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Worcester, Massachusetts, United States, 01655
- University of Massachusetts Medical School
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: 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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Motivation and Confidence in Physical Activity
Time Frame: Baseline and Post intervention (within 1 month)
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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.
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Baseline and Post intervention (within 1 month)
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Movement/Motor Skills
Time Frame: Baseline and Post intervention (within 1 month)
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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 professional will review and code the video-recorded TGMD-3 performance on each skill and provide a score at baseline and post-test.
For all of the ranges higher scores equal greater motor proficiency.
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Baseline and Post intervention (within 1 month)
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Desire to Participate in Physical Activity
Time Frame: Baseline and Post intervention (within 1 month)
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The adequacy and predilection for physical activity subscale of the Canadian Assessment of Physical Literacy - 2nd Ed (CAPL-2) Questionnaire estimates 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 is a shortened and refined version of the original CAPL Questionnaire.
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 activity.
For all ranges higher scores indicate higher levels of perceived self concept, motivation, and competency for physical activity.
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Baseline and Post intervention (within 1 month)
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Healthy Food Knowledge.
Time Frame: Baseline and Post intervention (within 1 month)
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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.
Higher scores indicate increased knowledge.
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Baseline and Post intervention (within 1 month)
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Foods Participant is Willing to Eat
Time Frame: Baseline and Post intervention (within 1 month)
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To assess teens' willingness to eat specific foods, parents completed a modified Food Frequency Questionnaire that contained a list of 108 common foods to report their teen's willingness to eat various food items ("no, my teen will not eat this" and "yes, my teen will eat this"). Parents who reported that they have not served the food item to their child were coded as missing. Parent responses were dichotomized to indicate teen willingness to eat the food and summed within their respective food groups (vegetables, fruits, proteins, grains, and dairy). The mean number of foods for each food group was used for analysis. Higher values indicate an increase in the participants' willingness to eat the foods in the specified food group. |
Baseline and Post intervention (within 1 month)
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Food Categorization
Time Frame: Baseline and Post Intervention (within 1 month)
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Participants will be asked to classify individual foods into food groups (e.g., an apple belongs in the fruit group).
For each item, answers are scored as correct or incorrect (0 or 1) or "I don't know" (0) and summed for a total of percent correct.
Higher percentage scores indicate increased ability to classify foods correctly.
Range is 0-100%.
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Baseline and Post Intervention (within 1 month)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Participant (Teen) Enjoyment and Satisfaction
Time Frame: Week 12
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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.
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Week 12
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Parent Satisfaction
Time Frame: Week 12
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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.
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Week 12
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Attendance
Time Frame: Weekly for 12 weeks
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Attendance was recorded at each weekly session of the 12-week intervention.
Absences and withdrawals were documented.
The total % of sessions that all participants attended is reported.
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Weekly for 12 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Carol Curtin, PhD, University of Massachusetts, Worcester
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H00017816
- 1R21HD099435-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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