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New Skills - No Scores Research Study

A Pilot and Feasibility Study to Promote Physical and Food Literacy Among Children With Intellectual Disabilities

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04254666
Enrollment
6
Registered
2020-02-05
Start date
2020-01-24
Completion date
2022-08-01
Last updated
2023-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intellectual Disability

Keywords

physical literacy, food literacy

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.

Interventions

BEHAVIORALPhysical Literacy & Food Literacy Intervention.

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.

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
University of Massachusetts, Boston
CollaboratorOTHER
Tufts University
CollaboratorOTHER
University of Massachusetts, Worcester
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 16 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Food CategorizationBaseline and Post Intervention (within 1 month)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%.
Desire to Participate in Physical ActivityBaseline and Post intervention (within 1 month)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.
Healthy Food Knowledge.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. Higher scores indicate increased knowledge.
Foods Participant is Willing to EatBaseline and Post intervention (within 1 month)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.
Motivation and Confidence in Physical ActivityBaseline 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/Motor SkillsBaseline and Post intervention (within 1 month)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.

Secondary

MeasureTime frameDescription
Participant (Teen) Enjoyment and SatisfactionWeek 12Will 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.
AttendanceWeekly for 12 weeksAttendance 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.
Parent SatisfactionWeek 12Will 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. Physical Literacy & Food Literacy Intervention.: 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.
6
Total6

Baseline characteristics

CharacteristicPhysical Literacy & Food Literacy Intervention
Age, Categorical
<=18 years
6 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
5 Participants
Region of Enrollment
United States
6 participants
Sex: Female, Male
Female
2 Participants
Sex: Female, Male
Male
4 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 6
other
Total, other adverse events
0 / 6
serious
Total, serious adverse events
0 / 6

Outcome results

Primary

Desire to Participate in Physical Activity

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.

Time frame: Baseline and Post intervention (within 1 month)

ArmMeasureGroupValue (MEAN)Dispersion
Physical Literacy & Food Literacy InterventionDesire to Participate in Physical ActivityBaseline - Perceived Competence for PA (Range: 0 - 3)1.5 score on a scaleStandard Deviation 1.38
Physical Literacy & Food Literacy InterventionDesire to Participate in Physical ActivityPost Intervention - Perceived Competence for PA (Range: 0 - 3)2.67 score on a scaleStandard Deviation 0.52
Physical Literacy & Food Literacy InterventionDesire to Participate in Physical ActivityBaseline - Intrinsic Motivation for PA (Range: 0 - 3)2.0 score on a scaleStandard Deviation 0.89
Physical Literacy & Food Literacy InterventionDesire to Participate in Physical ActivityPost Intervention - Intrinsic Motivation for PA (Range: 0 - 3)2.67 score on a scaleStandard Deviation 0.52
Physical Literacy & Food Literacy InterventionDesire to Participate in Physical ActivityBaseline - Perceived Adequacy for Sports and Active Games (Summed score; Range: 0 - 6)4.17 score on a scaleStandard Deviation 1.94
Physical Literacy & Food Literacy InterventionDesire to Participate in Physical ActivityPost Intervention - Perceived Adequacy for Sports and Active Games (Summed score; Range: 0 - 6)4.67 score on a scaleStandard Deviation 1.86
Primary

Food Categorization

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%.

Time frame: Baseline and Post Intervention (within 1 month)

ArmMeasureGroupValue (MEAN)Dispersion
Physical Literacy & Food Literacy InterventionFood CategorizationBaseline Categorization of food into food groups (% Correct)64.7 percent correctStandard Deviation 47.8
Physical Literacy & Food Literacy InterventionFood CategorizationPost Intervention Categorization of food into food groups (% Correct)79.3 percent correctStandard Deviation 40.5
Primary

Foods Participant is Willing to Eat

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.

Time frame: Baseline and Post intervention (within 1 month)

ArmMeasureGroupValue (MEAN)Dispersion
Physical Literacy & Food Literacy InterventionFoods Participant is Willing to EatBaseline - Vegetables (mean)20.83 number of foods in food groupStandard Deviation 4.58
Physical Literacy & Food Literacy InterventionFoods Participant is Willing to EatPost Intervention - Vegetables (mean)23.5 number of foods in food groupStandard Deviation 4.81
Physical Literacy & Food Literacy InterventionFoods Participant is Willing to EatBaseline - Fruits (mean)16.17 number of foods in food groupStandard Deviation 4.67
Physical Literacy & Food Literacy InterventionFoods Participant is Willing to EatPost Intervention - Fruits (mean)17.00 number of foods in food groupStandard Deviation 4.43
Physical Literacy & Food Literacy InterventionFoods Participant is Willing to EatBaseline - Proteins (mean)13.83 number of foods in food groupStandard Deviation 1.94
Physical Literacy & Food Literacy InterventionFoods Participant is Willing to EatPost Intervention - Proteins (mean)14.83 number of foods in food groupStandard Deviation 1.6
Physical Literacy & Food Literacy InterventionFoods Participant is Willing to EatBaseline - Grains (mean)11.50 number of foods in food groupStandard Deviation 1.64
Physical Literacy & Food Literacy InterventionFoods Participant is Willing to EatPost Intervention - Grains (mean)13.17 number of foods in food groupStandard Deviation 1.17
Physical Literacy & Food Literacy InterventionFoods Participant is Willing to EatBaseline - Dairy (mean)3.50 number of foods in food groupStandard Deviation 0.55
Physical Literacy & Food Literacy InterventionFoods Participant is Willing to EatPost Intervention - Dairy (mean)3.83 number of foods in food groupStandard Deviation 0.41
Primary

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. Higher scores indicate increased knowledge.

Time frame: Baseline and Post intervention (within 1 month)

ArmMeasureGroupValue (MEAN)Dispersion
Physical Literacy & Food Literacy InterventionHealthy Food Knowledge.Baseline - Identifying Whole Grain Foods (Range: 0 - 5)3.17 score on a scaleStandard Deviation 0.75
Physical Literacy & Food Literacy InterventionHealthy Food Knowledge.Post Intervention - Identifying Whole Grain Foods (Range: 0 - 5)3.33 score on a scaleStandard Deviation 0.82
Physical Literacy & Food Literacy InterventionHealthy Food Knowledge.Baseline - Identifying Drinks with Less Sugar (Range: 0 - 2)1.5 score on a scaleStandard Deviation 0.84
Physical Literacy & Food Literacy InterventionHealthy Food Knowledge.Post Intervention - Identifying Drinks with Less Sugar (Range: 0 - 2)1.83 score on a scaleStandard Deviation 0.41
Physical Literacy & Food Literacy InterventionHealthy Food Knowledge.Baseline - Identifying the Healthier Meal (Range: 0 - 2)1.33 score on a scaleStandard Deviation 1.03
Physical Literacy & Food Literacy InterventionHealthy Food Knowledge.Post Intervention - Identifying the Healthier Meal (Range: 0 - 2)1.83 score on a scaleStandard Deviation 0.41
Physical Literacy & Food Literacy InterventionHealthy Food Knowledge.Baseline - Identifying the Healthier Snack (Range: 0 - 3)2.33 score on a scaleStandard Deviation 1.03
Physical Literacy & Food Literacy InterventionHealthy Food Knowledge.Post Intervention - Identifying the Healthier Snack (Range: 0 - 3)2.33 score on a scaleStandard Deviation 1.21
Primary

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.

Time frame: Baseline and Post intervention (within 1 month)

ArmMeasureGroupValue (MEAN)Dispersion
Physical Literacy & Food Literacy InterventionMotivation and Confidence in Physical ActivityBaseline - Global Self-concept (Range: 0 - 4)3.42 score on a scaleStandard Deviation 0.74
Physical Literacy & Food Literacy InterventionMotivation and Confidence in Physical ActivityPost Intervention - Global Self-concept (Range: 0 - 4)3.42 score on a scaleStandard Deviation 0.8
Physical Literacy & Food Literacy InterventionMotivation and Confidence in Physical ActivityBaseline - Physical Self-worth (Range: 0 - 4)3.17 score on a scaleStandard Deviation 0.98
Physical Literacy & Food Literacy InterventionMotivation and Confidence in Physical ActivityPost Intervention - Physical Self-worth (Range: 0 - 4)3.42 score on a scaleStandard Deviation 0.92
Physical Literacy & Food Literacy InterventionMotivation and Confidence in Physical ActivityBaseline - Physical Condition (Range: 0 - 4)2.50 score on a scaleStandard Deviation 1.26
Physical Literacy & Food Literacy InterventionMotivation and Confidence in Physical ActivityPost Intervention - Physical Condition (Range: 0 - 4)2.75 score on a scaleStandard Deviation 0.69
Physical Literacy & Food Literacy InterventionMotivation and Confidence in Physical ActivityBaseline - Sport Competence (Range: 0 - 4)2.92 score on a scaleStandard Deviation 0.8
Physical Literacy & Food Literacy InterventionMotivation and Confidence in Physical ActivityPost Intervention - Sport Competence (Range: 0 - 4)3.33 score on a scaleStandard Deviation 0.52
Physical Literacy & Food Literacy InterventionMotivation and Confidence in Physical ActivityBaseline - Physical Attractiveness (Range: 0 - 4)3.08 score on a scaleStandard Deviation 0.66
Physical Literacy & Food Literacy InterventionMotivation and Confidence in Physical ActivityPost Intervention - Physical Attractiveness (Range: 0 - 4)3.17 score on a scaleStandard Deviation 0.88
Physical Literacy & Food Literacy InterventionMotivation and Confidence in Physical ActivityBaseline - Physical Strength (Range: 0 - 4)2.92 score on a scaleStandard Deviation 0.86
Physical Literacy & Food Literacy InterventionMotivation and Confidence in Physical ActivityPost Intervention - Physical Strength (Range: 0 - 4)3.17 score on a scaleStandard Deviation 0.68
Primary

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 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.

Time frame: Baseline and Post intervention (within 1 month)

ArmMeasureGroupValue (MEAN)Dispersion
Physical Literacy & Food Literacy InterventionMovement/Motor SkillsBaseline - Catch (Range: 0 - 6)5.0 score on a scaleStandard Deviation 1.1
Physical Literacy & Food Literacy InterventionMovement/Motor SkillsBaseline - Total Motor Skills (Range: 0 - 66) (higher indicate better motor skills)24.0 score on a scaleStandard Deviation 10.6
Physical Literacy & Food Literacy InterventionMovement/Motor SkillsPost Intervention - Total Motor Skills (Range: 0 - 66)27.8 score on a scaleStandard Deviation 14.2
Physical Literacy & Food Literacy InterventionMovement/Motor SkillsBaseline - Locomotive Skills (Range: 0 - 30)7.8 score on a scaleStandard Deviation 6.4
Physical Literacy & Food Literacy InterventionMovement/Motor SkillsPost Intervention - Locomotive Skills (Range: 0-30)7.7 score on a scaleStandard Deviation 5.5
Physical Literacy & Food Literacy InterventionMovement/Motor SkillsBaseline - Hop (Range: 0 - 8)2.17 score on a scaleStandard Deviation 1.83
Physical Literacy & Food Literacy InterventionMovement/Motor SkillsPost Intervention - Hop (Range: 0 - 8)2.5 score on a scaleStandard Deviation 2.17
Physical Literacy & Food Literacy InterventionMovement/Motor SkillsBaseline - Skip (Range: 0 - 6)1.33 score on a scaleStandard Deviation 2.07
Physical Literacy & Food Literacy InterventionMovement/Motor SkillsPost Intervention - Skip (Range: 0 - 6)0.66 score on a scaleStandard Deviation 1.03
Physical Literacy & Food Literacy InterventionMovement/Motor SkillsBaseline - Jump (Range: 0 - 8)2.67 score on a scaleStandard Deviation 1.51
Physical Literacy & Food Literacy InterventionMovement/Motor SkillsPost Intervention - Jump (Range: 0 - 8)2.83 score on a scaleStandard Deviation 2.48
Physical Literacy & Food Literacy InterventionMovement/Motor SkillsBaseline - Slide (Range: 0 - 8)1.67 score on a scaleStandard Deviation 1.03
Physical Literacy & Food Literacy InterventionMovement/Motor SkillsPost Intervention - Slide (Range: 0 - 8)1.67 score on a scaleStandard Deviation 0.82
Physical Literacy & Food Literacy InterventionMovement/Motor SkillsBaseline - Ball Skills (Range: 0 - 36)16.2 score on a scaleStandard Deviation 7.1
Physical Literacy & Food Literacy InterventionMovement/Motor SkillsPost Intervention - Ball Skills (Range: 0 - 36)20.2 score on a scaleStandard Deviation 9
Physical Literacy & Food Literacy InterventionMovement/Motor SkillsBaseline - Dribble (Range: 0 - 6)2.17 score on a scaleStandard Deviation 2.14
Physical Literacy & Food Literacy InterventionMovement/Motor SkillsPost Intervention - Dribble (Range: 0 - 6)3.0 score on a scaleStandard Deviation 1.9
Physical Literacy & Food Literacy InterventionMovement/Motor SkillsPost Intervention - Catch (Range: 0 - 6)5.0 score on a scaleStandard Deviation 1.55
Physical Literacy & Food Literacy InterventionMovement/Motor SkillsBaseline - Kick (Range: 0 - 8)2.0 score on a scaleStandard Deviation 1.41
Physical Literacy & Food Literacy InterventionMovement/Motor SkillsPost Intervention - Kick (Range: 0 - 8)2.83 score on a scaleStandard Deviation 2.93
Physical Literacy & Food Literacy InterventionMovement/Motor SkillsBaseline - Overhand Throw (Range: 0 - 8)1.0 score on a scaleStandard Deviation 1.67
Physical Literacy & Food Literacy InterventionMovement/Motor SkillsPost Intervention - Overhand Throw (Range: 0 - 8)1.83 score on a scaleStandard Deviation 2.48
Physical Literacy & Food Literacy InterventionMovement/Motor SkillsBaseline - Underhand Throw (Range: 0 - 8)3.67 score on a scaleStandard Deviation 3.14
Physical Literacy & Food Literacy InterventionMovement/Motor SkillsPost Intervention - Underhand Throw (Range: 0 - 6)4.83 score on a scaleStandard Deviation 1.94
Secondary

Attendance

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.

Time frame: Weekly for 12 weeks

ArmMeasureValue (NUMBER)
Physical Literacy & Food Literacy InterventionAttendance87.5 % sessions the participants attended
Secondary

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.

Time frame: Week 12

ArmMeasureGroupValue (NUMBER)
Physical Literacy & Food Literacy InterventionParent Satisfaction% parents reporting that program was effective in motivating their teen to eat healthy foods.83 % parents indicating agreement
Physical Literacy & Food Literacy InterventionParent Satisfaction% parents reporting program was effective in increasing teens interest physical activity/sports50 % parents indicating agreement
Physical Literacy & Food Literacy InterventionParent Satisfaction% parents reporting they would recommend the program to other families of teens with ID83 % parents indicating agreement
Physical Literacy & Food Literacy InterventionParent Satisfaction% parents reporting overall satisfaction with the program83 % parents indicating agreement
Secondary

Participant (Teen) 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.

Time frame: Week 12

ArmMeasureGroupValue (NUMBER)
Physical Literacy & Food Literacy InterventionParticipant (Teen) Enjoyment and SatisfactionPercent reporting liking the sport skills part of the program100 % participants indicating agreement
Physical Literacy & Food Literacy InterventionParticipant (Teen) Enjoyment and Satisfactionpercent reporting liking the sports skills practice between sessions50 % participants indicating agreement
Physical Literacy & Food Literacy InterventionParticipant (Teen) Enjoyment and Satisfactionpercent reporting liking the nutrition education83 % participants indicating agreement
Physical Literacy & Food Literacy InterventionParticipant (Teen) Enjoyment and Satisfactionpercent reporting liking the taste tests83 % participants indicating agreement
Physical Literacy & Food Literacy InterventionParticipant (Teen) Enjoyment and Satisfactionpercent reporting liking trying two new foods each week100 % participants indicating agreement
Physical Literacy & Food Literacy InterventionParticipant (Teen) Enjoyment and Satisfactionpercent reporting that the sports skills were just right83 % participants indicating agreement
Physical Literacy & Food Literacy InterventionParticipant (Teen) Enjoyment and Satisfactionpercent reporting the nutrition education sessions were just right83 % participants indicating agreement

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026