New Skills - No Scores Research Study
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|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
|Condition or disease||Intervention/treatment||Phase|
|Intellectual Disability||Behavioral: Physical Literacy & Food Literacy Intervention.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|United States, Massachusetts|
|Woburn Boys & Girls Club|
|Woburn, Massachusetts, United States, 01801|
|University of Massachusetts Medical School|
|Worcester, Massachusetts, United States, 01655|
|Principal Investigator:||Carol Curtin, PhD||University of Massachusetts, Worcester|