A Pilot and Feasibility Study to Promote Physical and Food Literacy Among Children With Intellectual Disabilities
Phase: NA
Conditions: Intellectual Disability
Sponsor: University of Massachusetts, Worcester

 
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DOCUMENT: INVESTIGATOR STUDY PLAN 
 
 
STUDY TITLE: A Pilot and Feasibility Study to Promote Physical and Food Literacy 
among Children with Intellectual Disabilities (Study Nickname: New Skills – No Scores) 
 
 
NCT#: NCT04254666 
 
 
DOCUMENT DATE: 11/9/21 (IRB approval 3/17/22) 
 
 
 

 
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1. TITLE 
A Pilot and Feasibility Study to Promote Physical and Food Literacy among Children with 
Intellectual Disabilities (Study Nickname: New Skills – No Scores 
 
2. EXTERNAL IRB REVIEW HISTORY* 
UMass Chan will be the lead institution and reliance agreements have been put in place with 
Tufts University and UMass Boston. 
 
3. PRIOR APPROVALS:  N/A 
 
4. OBJECTIVES* 
The specific aims of the study are as follows: 
 
(1) To test the feasibility of a remote physical literacy and food literacy intervention for 
adolescents with ID ages 12-16 years. 
 
(2)  To assess preliminary efficacy of the intervention for increasing: 
 
a) physical literacy including movement skills, physical self-concept, and desire to 
participate in physical activity. 
 
b) food literacy including knowledge around making healthy food choices, basic food 
preparation skills, and engaging in healthy eating behavior. 
 
We hypothesize that demand for the intervention will be similar to our previous studies (high 
level of interest), and attendance and retention will be high (≤10% dropout). We also hypothesize 
that participants will enjoy the intervention, and that parents and participants will be satisfied 
with the intervention and perceive it as appropriate. We expect that implementation fidelity will 
be high (>80% of checklist items on average) and that participants will show significant 
improvements in physical literacy and food literacy outcomes. This pilot and feasibility study 
represents an important first step toward promoting health and reducing inequities that exist for 
adolescents with ID. If successful, the next step is a larger controlled study to test whether 
changes in physical literacy and food literacy skills can promote increased physical activity and 
healthier food choices in adolescents with ID. 
 
5. BACKGROUND* 
This information described extensively in the grant narrative that has been uploaded into the 
eIRB system.  Below is a brief description of the background/context for the study: 
 
Regular participation in physical activity (PA) maintains health and reduces the risk of disease. 
In children and youth, benefits include improved blood pressure, bone health,4health-
relatedfitness, psychological health, and preventing/treating obesity.  The US guidelines for 
children recommend at least 60 min/day of moderate-to-vigorous activity but less than 25% 
children meet this goal. PA levels are lower in girls than boys, and decline from childhood to 
adolescence. 53 Children with intellectual disabilities (ID) are no exception; most do not meet 

 
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the guidelines and are less active than their typically developing (TD) peers.  A healthy diet is 
also necessary for overall health and well-being. The Dietary Guidelines for Americans are 
promulgated to help people make healthy food and beverage choices. Data from the 2015 Youth 
Risk Behavior Surveillance Survey suggest that a substantial number of youth do not meet these 
guidelines; only 61% of high school youth consumed ≥1 vegetables and only 63% consumed ≥1 
servings of fruit or 100% fruit juice daily. Although data on dietary intake of children and youth 
with ID are lacking, our work in youth with ID suggests that many do not meet the dietary 
guidelines for fruits/vegetable intake and that their diets are high in added sugars. Barriers to 
healthy eating include lack of knowledge about food in today’s complex food environment 
which makes decision-making around food choices difficult. Other barriers include difficulty 
estimating portions sizes, food selectivity, and limited of access to healthy foods.57 
 
The concept of physical literacy has gained considerable momentum internationally in health 
promotion research, practice, and policy. The International Physical Literacy Association 
describes physical literacy as “the motivation, confidence, physical competence, knowledge and 
understanding to value and take responsibility for engagement in physical activities for life.” It 
imparts the knowledge and tools to pursue and enjoy a variety of sports and PA. Physical literacy 
is considered the gateway to an active lifestyle. In the US, the physical literacy movement is 
embraced by organizations like the American College of Sports Medicine and President’s 
Council on Fitness, Sports & Nutrition. In 2014, “physically literate” replaced “physically 
educated” as the goal for all students in the US National Standards for Physical Education.  
 
The essential components of physical literacy, in the US definition, are:  
1) Ability: competency in basic movement skills and overall fitness: 
2) Confidence: self-efficacy for the ability to play sports or enjoy physical activities: and  
3) Desire: the intrinsic enthusiasm for PA.  
 
These components build on one another and provide the foundation to be active for life. 
Specifically, as children develop proficiency in movement skills, their increased confidence in 
their ability leads to greater enjoyment and motivation to participate. Mastering fundamental 
movement skills such as jumping, running, catching, and throwing is considered to be the most 
important step toward developing physical literacy. Children and adolescents with more 
developed motor skills are more active/fit, which enhances movement proficiency and increases 
overall activity levels.  
 
Food literacy has also gained recent attention and has been defined as “the capacity to obtain, 
process and understand basic information about food and nutrition as well as the competence to 
use that information in order to make appropriate health decisions,” although a standard 
definition of this concept is not yet established. A food literacy intervention for adolescents with 
ID must consider the adaptations needed to make information accessible and understandable, 
teach skills that are reasonable and manageable, and meet the needs of a heterogeneous 
population. The range of knowledge in adolescents with ID is likely to be quite variable.  
Although adolescents with ID may live in supervised settings or at home with their parents, they 
nevertheless make food choices throughout their day. Thus, they need to be able to identify 
healthy food choices and be able to identify unhealthy foods which are often the targets of 
marketing and advertising. Moreover, adolescents with ID have higher rates of food selectivity 

 
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than their TD peers, which may be a result of sensory sensitivities, behavioral rigidity, and/or 
preferences for familiar foods. These adolescents need to be exposed to healthy foods in a 
positive and supportive manner. Food literacy is critical to the health of adolescents with ID who 
require requisite knowledge and skills for making healthy choices, especially as they move 
toward more independent living. 
 
6. INCLUSION AND EXCLUSION CRITERIA* 
The participants in this study will be 30 male (n=15) and female (n=15) adolescents with 
intellectual disabilities (ID) ages 12-16 years. Because the etiology of ID is variable with many 
known and unknown causes, we expect the sample will include adolescents with various 
syndromes such as Down syndrome, Fragile X, Williams syndrome, as well as adolescents with 
ID of unknown etiology.  
 
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. 
• in-home space that is a minimum of 7 feet by 10 feet to allow the participant enough 
room to complete the TGMD-3 and the physical activity component of the intervention 
 
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 or noncompliance 
 
We will seek approval from participants’ physicians and specialists to ensure they can participate 
safely. 
 
7. STUDY-WIDE NUMBER OF SUBJECTS*  N/A 
 
8. STUDY-WIDE RECRUITMENT METHODS*  N/A  
 
9. STUDY TIMELINES* 
The table on the next page depicts study activities over the two years of the project. The 12-week 
intervention will run remotely in three concurrent waves/cohorts of 10 participants (winter/spring 
2022 through summer 2022). Conducting the intervention remotely will allow us to recruit 

 
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throughout the state of Massachusetts, which will assist in enrolling the planned number of 
participants (n=30).   
 
The study was put on-hold in March 2020 due to COVID shortly after enrolling participants and 
commencing with the intervention. The timeline listed below illustrates our new plan. 
 
 

 
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Year 2 
Sept  1 2020 to Aug 31 2021 
Year 3 – Current Year (no-cost extension) 
Sept 1 2021 to Aug 31 2022 
Tasks ò                  Months ð 
S 
O 
N 
D 
J 
F 
M 
A 
M 
J 
J 
A 
S 
O 
N 
D 
J 
F 
M 
A 
M 
J 
J 
A 
Participant-related activities suspended 
due to COVID-19 
X 
X 
X 
X 
XX 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Start-up activities – hire staff, training 
and preparation 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
Recruit, screen, & enroll participants 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
 
 
 
 
 
 
Data collection – baseline measures 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
 
 
 
 
 
 
Intervention  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
 
 
Data collection – post intervention 
measures 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Data coding, entry & analysis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
Dissemination - presentation and 
manuscript preparation. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 

 
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10. STUDY ENDPOINTS* 
The measures used in this project are designed test the feasibility of the intervention and assess 
its preliminary efficacy for increasing physical literacy and food literacy in adolescents with ID. 
Measures of physical literacy and food literacy will be obtained at baseline and after the 12-
week intervention. 
 
Below are brief descriptions of the measures – these are also described in the grant application, 
which includes bibliographic references for validated measures. 
 
(1) General sample characterization 
We will collect the following information at baseline to characterize the sample: 
• Demographic Questionnaire.  Parents will be asked to complete a demographic 
questionnaire that contains basic demographic questions about the adolescent’s date of 
birth, sex, adolescent/family race/ethnicity, and parent education.   This questionnaire 
also contains questions about individual, social, community, and family barriers to 
physical activity for the adolescent.  
 
(2) Feasibility Measures 
Process measures of demand, acceptability, and implementation will be obtained as follows: 
• Demand will be assessed by documenting number of inquiries into the program and 
number of participants screened and enrolled. Attendance will be recorded for each 
session and we will document reasons for any absences. Withdrawal, date of withdrawal, 
and reasons will also be documented.  
• Acceptability will be assessed via participant and parent surveys of enjoyment, 
satisfaction, and perceived appropriateness at weeks 6 and 12. Surveys will be adapted 
from those used in our previous work, and will include close-ended questions with Likert 
scale response options and opportunities for open-ended feedback. The participant survey 
will be simple and will include visual cues (e.g., happy face for “like it”) to assist in 
understanding questions and response choices. The survey will be administered orally 
and will take about 15 minutes. Participants will be queried about program elements such 
as: appropriateness and enjoyment of the sport/healthy eating activities; sports 
equipment; support/instructional methods used by staff; using Zoom to conduct the 
intervention remotely; barriers/facilitators of participation in physical activity and healthy 
eating; enjoyment of interactions with other adolescents; preferred sports and taste test 
foods; perceived improvements in physical/food literacy; and enjoyment/perceptions of 
“Bring it Home and Give it a Try” activities. Parent satisfaction via a survey will query 
perceptions such as: program quality; benefits to adolescent; staff effectiveness; 
appropriateness of activities; adolescent enjoyment; quality of the facility; and barriers 
to/facilitators of participation.  
• Implementation will be assessed via documenting the factors affecting program 
implementation and sufficiency of resources (e.g., space, staff), and fidelity checks. 
Through observation and discussions with staff, participants, and parents, we will 
document: adaptations made to increase success; effective/ineffective strategies used to 
promote participation; most appropriate sports; quality of activity sessions; and barriers 
and facilitators encountered. Fidelity checks will be conducted in 25% of the program 

 
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sessions starting in week 3 to assess the degree to which the intervention is implemented 
as planned. We will develop a checklist with critical elements of the program and will 
discretely observe and record if the elements are executed. Protocol “violations” will be 
recorded and brought to the investigative team for discussion and trouble-shooting. In 
addition, we will have all active staff complete a Field Notes form at the end of each 
session to note any challenges with the session and/or participants. While these forms 
will have participant names on them they will be stored in a locked box after the session 
and brought de-identified as soon as possible by redacting the name and adding the 
subject ID instead.        
• Session Observation Form: The Session Observation Form will be completed by 
nutrition students who will be involved in the intervention.  During and immediately 
following the session they will take notes and fill out the form in order to capture aspects 
of program implementation.  This form will assist us to evaluate the feasibility of and 
participant engagement with the program. 
 
(3) Measures of Physical Literacy  
• Movement Skills.   Test of Gross Motor Development-Third Edition (TGMD-3) will 
be used to measure movement skills. The TGMD-3 assesses 13 fundamental motor skills 
that are divided into two sub-scales: 1) locomotor skills and 2) ball skills. The TGMD-3 
is a direct observation skill assessment with 3-5 performance criteria for each skill.  The 
following skills from the TGMD-3 will be assessed: 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 (i.e., remotely) at baseline and post-
12 weeks. Specifically, a trained tester will provide verbal instructions and 
demonstrations for each skill on the TGMD during a recorded Zoom meeting.  A 
parent/guardian will assist by ensuring that the participant’s performance is clearly 
visible in the frame of the camera and may provide prompting and/or clarification to their 
child.  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.   
• 
Motivation and Confidence in Physical Activity. As an indicator of confidence, 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 simple, 
accommodates short attention span, and assesses the multidimensionality of physical self-
concept. The PSI-VSF-ID has 12 items that measure 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. We have modified the 
language of the items of the PSI-VSF-ID for clarity and understanding by children with 
ID based on our extensive experience with this population. The 3-item confidence 
subscale, and 3-item motivation subscale of the Canadian Assessment of Physical 
Literacy – Second Edition (CAPL-2) Questionnaire will also be used to assess 
participant confidence in their ability to be physically active and motivation to participate 
in physical activity. This combined 18-item questionnaire including the PSI-VSF-ID and 
CAPL-2 subscales will be verbally administered virtually over Zoom.  We reduced the 

 
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number of response options to four to accommodate children with ID who may find 5 or 
6 choices difficult, and modified the language so that there was consistency across all of 
the 18 items in the combined motivation and confidence questionnaire.  The response 
options are simply-worded for children with ID, and range from “yes, definitely” to “no, 
definitely not”.    
• 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 activities and an adolescent chooses the option that is most like them.  For 
example, “some kids don’t have much fun playing sports” and “other kids have a good 
time playing sports.” We have modified the response items to ask participants to select 
which option is most like them. The CAPL-2 Questionnaire subscale will be verbally 
administered virtually over Zoom. Total scores will range from 0-6 with an item response 
assigned 0 or 1.  
  
(4) Measures of Food Literacy 
• Healthy Food Knowledge. 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 (e.g., an apple 
belongs to the fruit group) (5 foods for each of the 5 food groups).  The participants will 
be shown three pictures of whole grain foods in their packaging and three pictures of 
non-whole grain foods in their packaging and asked to indicate whether or not each food 
is a whole grain. We will do qualitative probes to understand why/how the participant 
selected their response. Likewise, participants will be presented with a bottle of water and 
a bottle of soda and asked which has less sugar.  This will be repeated with water and a 
sports drink. Qualitative probes will query the reason for the answer. Participants will be 
shown 2 plates of food: (1) chicken, rice, and broccoli; and (2)  chicken, rice, and bread, 
and asked which is the healthier meal. Again, we will query why they made the choice 
they did. This question will be repeated with 2 other plates of food: (1) salmon, quinoa, 
and asparagus; and (2) salmon, quinoa, and bread. This assessment will be administered 
remotely via Zoom.  
• Healthy Eating Behavior.  
o Changes in adolescent dietary behavior will be obtained by parent proxy from 
modificiations of the dietary assessment questions as part of the Youth Risk 
Behavioral Surveillance Survey (YRBSS). There are 9 questions related to dietary 
intake that align with our lessons around fruit/vegetables and added sugars. 
Parents will be asked to answer questions on the YRBSS about their adolescents’ 

 
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intake of fruits and vegetables and sugar-sweetened beverages over the past week. 
A proxy measure of food intake is most appropriate given the wide range of 
cognitive abilities we expect among participants and difficulty with accurate 
recall. Parents will complete the 9 questions for their adolescent at baseline and 
post-intervention virtually over Zoom, to yield a summary dietary behavior score. 
o We will also administer a modified food frequency questionnaire (FFQ) that we 
have developed for other studies that contains lists of foods organized by food 
group.  This will be administered virtually over Zoom. 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. 
 
11. PROCEDURES INVOLVED* 
 
Overview 
The intervention will be conducted remotely using Zoom. 
 
We will recruit 15 male and 15 female adolescents with ID ages 12-16. To establish the presence 
of ID (IQ ≤ 75), the Kaufman Brief Intelligence Test, 2nd ed. (KBIT-2) will be used to determine 
IQ score and the Vineland Adaptive Behavior Scales-III (VABS-III) will be used to assess 
adaptive functioning. Because the etiology of ID is variable, we expect the sample will include 
adolescents with various syndromes (e.g., Down syndrome, Fragile X, Williams syndrome) as 
well as those with autism and ID of unknown etiology.   The KBIT-2 will be administered 
remotely via Zoom by a trained research assistant per the protocol developed by the test 
developer Pearson Assessments.  The VABS-III will be completed online via the online 
administration program developed by Pearson.  
 
Participant Screening & Enrollment   
Parents will be phone-screened for their adolescent child’s eligibility via a or Zoom phone 
interview. The procedures for adolescents who meet the inclusion criteria on the phone screen 
will be as follows: 
o In order to determine they key inclusion criteria of the adolescent having an intellectual 
disability, parents will first be asked to complete an online version of the Vineland 
Adaptive Behavioral Scales-III which enables us to ascertain the adolescent’s adaptive 
behavior. They must receive a score of 75 or less to be eligible.   The VABS-III can be 
done at the time of the screening call with the RA or at another time of the parent’s 
choosing.  The RA can offer to be present during the time that the parent is completing 
this questionnaire in the event they have questions, but this is not necessary or a 
requirement.  Will give parents the option of how/when they wish to complete the 
VABS-III. Pearson Assessments provides an online platform for parents to complete the 
VABS-III. The platform will then automatically score the questionnaire. Pearson will not 
be provided with or have access to any identifying information about the parent or child. 

 
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o If the VABS-III yields a score of 75 or less, we will then schedule a Zoom meeting for 
the adolescent and their parent.  The RA will meet briefly with the adolescent to 
introduce himself to the adolescent and briefly describe the program.  If the adolescent 
indicates an interest and willingness to proceed, the RA will administer the Kaufman 
Brief Intelligence Test – 2 (KBIT-2) to confirm an IQ of 75 or less, which is required for 
classifying the adolescent as having an intellectual disability (ID).  If the KBIT-2 yields a 
score of 75 or lower, the rest of the enrollment meeting will proceed as described below. 
If the score is 76 or higher, the adolescent and parent will be told that the adolescent does 
not meet our screening criteria for ID. The KBIT-2 will be administered to the adolescent 
over Zoom, according to remote administration guidelines published by Pearson. 
o If the adolescent meets criteria for ID, we will then review the online Assent Form which 
has been constructed as a “social story” which provides visual supports/information as 
the RA describes the program to the adolescent.  We have chosen to acquire assent after 
the IQ test so that the participant does not potentially become interested/excited about the 
program only to be informed of the inability to participate, should they not meet inclusion 
criteria.   
o Upon completing the assent we will administer the baseline questionnaires described 
above to both the adolescent and parent, including the Food Knowledge Test. We will 
provide the option to have these take place at a separate, second enrollment session that 
will be virtual. We will also provide the parent with the option to complete the parent 
questionnaires independently, offline, and offer additional Zoom calls in the event they 
have any questions or are unable to complete the forms on their own.  
 
At the last enrollment session that will again take place over Zoom, the Test of Gross Motor 
Development-Third Edition (TGMD-3) measures will be administered by a trained professional 
with the help of the participant’s parent.  
 
One week prior to the start of the intervention, we will hold parent orientation Zoom calls to 
orient parents to the session structure, at-home components, and what their week-to-week 
responsibilities will be. 
 
Physical Literacy & Food Literacy Intervention.  
The 12-week intervention is 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 physical 
activities and make healthy food choices. The proposed sport sampling and healthy eating 
program will follow a protocol that can be adapted to meet the needs of a diverse group of 
adolescents with ID. Sessions will be held weekly for an hour and fifteen minutes. One cohort 
will meet Thursday evenings, the second cohort will meet Saturday mornings, and the third 
cohort will meet at a day/time that is to be determined based on the input of participating 
families on other days/times that would have worked for their schedules. 35 minutes will be 
dedicated to sport activities followed by 35 minutes dedicated to the curriculum on healthy 
eating with a 5 minute break in between. All sessions will be recorded to be coded as data at a 
later time by graduate students. 
 
Sport Skills Sampling. The sport skills program will be delivered remotely with modifications 
that promote engagement in activities at home.  The program will be organized by general sport 

 
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types/categories that are familiar to youth with ID and share key underlying motor skills.  Four 
(4) weeks will be dedicated to each sport type including: striking sports, running and jumping 
sports, and ball sports.  This classification of sport types (which are not mutually exclusive) will 
allow us to focus on fundamental locomotor and object control skills that are building blocks for 
a variety of sports, games, and physical activities, and that youth with ID can enjoy and practice 
on their own or with others. The selection of sport types is based on those that are popular for the 
age group, readily available to youth with ID in schools/communities (e.g., YMCAs), and part of 
Special Olympics. These include: baseball (striking sport); tennis (striking sport),;basketball (ball 
sport); soccer (ball sport); track and field (running and jumping sport); floor hockey (striking 
sport); volleyball (running and jumping sport); and gymnastics (running and jumping sport). 
Available physical literacy resources, materials, and curricula have guided the development of 
the sport skills curriculum and lessons. A “sports kit” will be delivered to each participant 
containing all the equipment that they will need to engage in the sports activities during each 
session (e.g., soft foam balls, cones, targets, paddles, jump rope, agility ladder).  The items in the 
kit will all be usable in an indoor home setting and suitable for small spaces.  
 
Sport sessions will be delivered by a Physical Activity Instructor with experience running 
physical activity/sport programs for youth with ID and familiar with instructional, motivational, 
and behavior modification strategies appropriate for this population. The Instructor will also 
have some experience delivering physical activity programs remotely.  The Instructor will lead 
and demonstrate all activities in the session and provide verbal instruction, prompting, corrective 
feedback, and encouragement to engage participants in the activities using proper form. The 
Research Assistant (RA) will assist the Instructor during the remote sessions to help keep 
participants on task.  
 
The first 5 minutes of each session will be an interactive greeting to introduce participants to the 
sport skills of the day, to highlight having fun and trying one’s best, and to gather the equipment 
needed for the activities. A 10-minute dynamic warm-up will prepare and engage participants for 
the skill circuit.  These 10 minutes will focus on “footwork for sports and games” and include 
fundamental movement skills (e.g., running, skipping, hopping, jumping, sideways sliding) 
designed to engage participants and build excitement. The footwork activities will use equipment 
to add interest for participants.  For 20 minutes, participants will engage in age- and 
developmentally-appropriate activities designed to foster movement proficiency through a series 
of 5-7 sport skill activities for 2-3 minutes each with a short rest/transition between each one. 
Activities will include catching, throwing, kicking, striking with a paddle, juggling, foot 
dribbling, and jumping, jogging, and hopping in place using equipment.  To increase enthusiasm 
and engagement, we will include individual, partner, and group challenges with many of the 
activities.    
 
As originally proposed, the sport skills program will include an additional opportunity for skill 
development via an at-home play/practice component. Participants will be encouraged to use the 
equipment from their kit to practice skills outside of the session. We will create activity cards 
and videos with simple and fun ideas for playing with the equipment both indoors and outdoors. 
The cards and videos will contain instructions, pictures, and motivational cues to encourage 
participants to practice kicking, dribbling, throwing, catching, jumping, etc. The goal of the 
practice is to have participants enjoy sports/physical activities in an unstructured way and to 

 
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provide greater exposure. Each session, the Instructor will ask participants if they practiced and 
to share their experiences. This will be a positive interaction with reinforcement, encouragement, 
and strategies for practicing skills at home if youth report challenges.  As before, we will ask 
participants to record their participation and submit it to us, but instead of paper-based recording, 
we will use an online reporting tool through REDCap. Participants will be reminded to input 
their at-home practice into REDCap using an automated text messaging and emailing application 
called Remind.  
 
Healthy Eating. After a brief break, youth and parents will meet with the Nutrition Educator after 
the sport sampling portion of the program. In general, nutrition sessions will focus on a simple 
nutrition messages, and will include demonstrations, brief interactive activities, some food 
preparation, and a taste test. In our experience, these sessions are best done in 30-minute blocks. 
 
We previously developed modules around healthy eating for adolescents with ID, Health U: A 
Nutrition Curriculum for Teenagers with Intellectual & Developmental Disabilities 
(www.tinyurl.com/HealthUCurriculum) that uses hands-on activities to teach about healthy 
eating. We have implemented these sessions in our weight management interventions and 
nutrition education programs for youth with ID. We are adapting and building on this curriculum 
for remote delivery. The program will begin with an introduction, followed by sessions focusing 
on how to incorporate foods from each food group into meals/snacks using “MyPlate” 
(www.choosemyplate.gov). The 12 modules include  the following topics: 1) Introduction to the 
nutrition education component of the program; 2) Learn about MyPlate and food groups; 3) 
Fruits; 4) Vegetables; 5) Dairy; 6) Whole grains; 7) Proteins; 8) Putting a healthy meal together; 
9) Added sugars; 10) Healthy snacks; 11) Promoting healthy snacks with fruits and vegetables; 
and 12) Planning a meal. Healthy eating principles will be reflected in the activities and we will 
regularly review previously covered material, as youth with ID need repetition and review to 
promote knowledge retention and skill development. Parents and youth will participate together 
in the sessions.  
 
Each session will begin with an introduction of the topic, followed by an activity and a taste test. 
Taste tests will be thematically related to the lesson and participants will help with basic food 
preparation, learning the skills of assembling and spreading to prepare snacks, such as yogurt and 
fruit smoothies. We will ask participants to rate the food as: “I like it”; “I don’t like it”; “I 
didn’t try it”; and “Maybe I will try it next time” using a rating sheet that includes words and 
pictures (emoticons).  
 
Each week the Nutrition Educator will start the session by asking the youth whether they tried a 
new food the previous week and what they thought about it.  They will then engage the group in 
a brief review of the previous week’s topic.  Next the Nutrition Educator will provide a brief 
review of the current week’s topic, after which youth and parents will be assigned to Zoom 
breakout rooms with 2-3 other parent/youth dyads.  In each break-out room a nutrition student 
will lead an activity related to the topic.  In some lessons, the group will remain together.   
 
Health Eating activity materials will be sent to the participants’ homes three times throughout the 
intervention. We will provide the food to families for the weekly sessions by way of a direct 
grocery delivery, if feasible, or by providing them with the financial resources to make the 

 
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purchases themselves.  The taste test foods will not require any cooking or heating to help 
minimize the time away from the group, as well as parental burden.  
 
We will apply the at-home practice concept of “Give it a try” to the healthy food component of 
the intervention as with the sport sampling. Youth will record any new foods they tried over the 
week using a simple online form through REDCap. At the beginning of each session the 
instructor will ask the youth to report any new foods they tried during the week as a way to 
engage them in discussion and help motivate them to try new foods. 
 
12. DATA AND SPECIMEN BANKING*  N/A 
 
13. Data Analysis and Management* 
All data will be double entered and linked by a common identification number across data 
sources. We will minimize missing data through careful checking of all surveys and data forms 
at the time of completion. Baseline characteristics of participants who drop out will be compared 
to those who complete the study. 
 
Analyses for Specific Aim #1. The process measures of feasibility will assess attendance, degree 
of participant enjoyment, and participant and parental satisfaction based the aforementioned 
surveys. These measures will be summarized as means and proportions, with corresponding 95% 
confidence intervals, and compared across the two waves. If there are no important differences, 
we will pool across waves. We will use the 6-week and 12-week measures to assess if 
engagement builds, sustains or declines over the intervention period. We will also examine study 
completion and attendance by wave. 
 
Analyses for Specific Aim #2a. To assess if the intervention increases aspects of physical 
literacy including movement competence (ability), confidence, and desire to participate in 
physical activity, we will conduct 1-sample paired t-tests for change (against the null hypothesis 
of a change of zero) in separate tests for TGMD-3 scores, PSI-VSF-ID physical self-concept, and 
CSAPPA score. We will construct 95% confidence intervals around the measure of change 
separately for boys and girls, and pool them if we discern no important differences by sex. If, 
based on Aim #1, we believe there were important implementation differences between the two 
waves, we will analyze them separately, acknowledging our power will be more limited. 
 
Analyses for Specific Aim #2b. Analyses to assess if the intervention increases elements of food 
literacy (i.e., knowledge and skills) for promoting intake of fruits and vegetables and for 
decreasing intake of high energy low nutrient dense snack foods will proceed as for Aim #2a. 
We will use a 1-sample (paired) t-test to test Food Knowledge, Food Skill Master, and Dietary 
Behavior scores. We will construct 95% confidence intervals around the change separately for 
boys and girls, pooling them if we discern no important difference by sex. If, based on Aim #1, 
we believe that there were important implementation differences across the two waves, we will 
analyze them separately, acknowledging our power will be more limited. 
 
Sample Size Considerations. We established the sample size for this pilot study based on the 
aforementioned total and skill score on the CAMSA (Specific Aim #2a). Using available 
estimates from TD adolescents, we calculated the sample sizes needed to capture a 15% change 

 
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in score for boys and girls separately (score improvements of 6.63 total; 3.66 skill). Estimates on 
the CAMSA from adolescents with ID are unavailable in the literature; however, we have no 
reason to believe that the proposed intervention would have a different impact on adolescents 
with ID than TD adolescents. We estimated the standard deviation of the change in the measure 
(5.19 total; 3.10 skill) and the interclass correlation coefficient (0.91 total; 0.80 skill), as 
recommended. A sample size of 12 boys and 12 girls has, at an alpha level of 0.05, 80% power 
to assess a difference of 15% in total score and 15% in skill score, analyzing boys and girls 
separately. We have proposed to enroll 15 boys and 15 girls in our pilot study to allow for 
attrition and or missing data. If we do not identify important differences in the change in score by 
sex we will combine them, with the result that we would have adequate power to detect changes 
of the magnitude ~5% total and skill scores. 
 
14. PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF SUBJECTS* 
The physical and food literacy intervention and measurement protocols pose minimal risks to 
participants. As a supervised sport sampling and healthy eating program that requires approval 
from each participant’s primary care physician and medical specialists (as needed), the proposed 
study represents a low-risk intervention. The intensity of the sports/physical activities will be 
guided and monitored by a physical activity instructor with experience instructing adolescents 
with ID and an academic background in exercise science and/or physical education. The healthy 
eating activities will be delivered by an experienced nutritionist/registered dietitian with at least 
an undergraduate degree in nutrition. Because of the minimal risk, the data safety monitoring 
plan for this study focuses on close monitoring by the PI and a data safety officer, along with 
prompt reporting of excessive and/or unexpected serious adverse events to the NIH and to the 
IRB at UMass Chan. 
 
We have identified a data safety officer for this study who has experience conducting physical 
activity/health promotion intervention studies for adolescents and youth with 
neurodevelopmental and behavioral health disorders, and thus has a  thorough understanding of 
the issues that arise in a combined program of this type. The data safety officer will review 
reports of any adverse events or unanticipated problems recorded by the study team. Although 
highly unexpected, participants could be injured during their physical activity participation or 
choke on food during the taste tests. We have not experienced these types of events in our 
previous studies and programs, but they are within the realm of possibility. We will mitigate 
these risks by providing close supervision of the participants so they do not engage in risky 
physical behaviors (e.g., over-exertion) or engage in problematic eating behaviors (e.g., over-
stuffing their mouths or rapid eating).  
 
The data safety officer will use a checklist to indicate whether there is any corrective action, 
trigger of an ad hoc review, or stopping rule that should be communicated to the study 
investigators, the UMass Chan IRB, or the NIH institute to which the project has been assigned. 
In addition, the data safety officer will comment on whether the PI needs to report any specific 
concerns to the participant, their parent(s), and/or their primary care physician. 
 
Personal identifying information (PII). The names of the participants will be obtained to ensure 
that the data are organized during data collection and for the intervention. Names will be 
transferred to a participant number when the data are entered into the computer and no names 

 
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will ever be published. Age and birthdate will also be required as will sex. The addresses and 
telephone numbers of the parent(s) of each participant will be required in order to maintain 
contact during the intervention. There will be no attempt to link the PII to the study data. 
 
15. WITHDRAWAL OF SUBJECTS WITHOUT THEIR CONSENT*   
Although we do not anticipate the need to withdraw participants without their consent, if we find 
that an individual adolescent is unable to participate in the program safely (i.e., to keep 
him/herself or others safe), we will first seek to address the behavior (i.e., address anxiety or 
other issues that might be leading to the problematic behavior), and engage the adolescents’ 
parents in problem-solving.  If those efforts are not successful, we will proceed to withdraw the 
adolescent from the study. 
 
16. RISKS TO SUBJECTS* 
There is the risk of a breach in confidentiality. Measures, described above, will be put in place to 
lessen this risk.  
 
The physical literacy and food literacy intervention and measurement protocols pose minimal 
risks to participants. As a supervised sport sampling and healthy eating educational program that 
requires approval from each participant’s primary care physician and any medical specialists (as 
needed), the proposed study represents a low-risk intervention.  
 
Physical Literacy component. The sport/physical activity stations and small group games will be 
classified as moderate intensity physical activity, and the Physical Activity Instructor will adjust 
the intensity, duration, and nature of the activities to accommodate those with lower stamina and 
to ensure safe participation. Participants will be encouraged to slow down and/or take breaks as 
necessary. The sport sampling lesson plans and activities will be guided by the Co-I, an expert in 
adapted physical activity. We do not anticipate that the participants would experience anything 
different from what they might encounter in a physical education class in school or in a 
community-based PA program. However, there is some potential that participants could 
experience bruises, cuts, scrapes, and/or muscle strains as a result of falling. It is likely that any 
injury will be temporary and easily addressed within their home setting with applying ice or a 
bandage. Participants who have particularly low levels of cardiorespiratory fitness may also find 
physical exertion during sports to be uncomfortable, though this will be monitored carefully by 
the Physical Activity Instructor to ensure that they are not overexerting themselves. 
 
We have put several safeguards into place to protect participants. The sport sampling 
sessions and activities will be delivered by a qualified Physical Activity Instructor who has prior 
experience delivering physical activity/sport programming to youth with disabilities, with 
support from the RA and student assistants. The physical activities/sports/games will be 
developmentally- and age-appropriate to maximize safety and minimize risk of injury. 
Participants will be repeatedly reminded of safety rules and encouraged to adhere to the rules.  
 
Healthy Eating (food literacy) component.  This component of the intervention poses no 
discernable risk to participants. The session will involve games and activities to increase healthy 
food knowledge directed by a Nutritionist or nutrition graduate student with guidance from the 
Co-Investigator, an expert in the field of obesity and nutrition. The food preparation activities 

 
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will not require participants to use knives or other sharp kitchen tools. The Nutritionist will 
review safe food preparation and handling with participants and parents for the taste tests, and 
will have knowledge of any participant food allergies so that safe foods will be provided. 
 
The healthy eating activities, educational lessons, and taste tests will be delivered by a 
nutritionist with support from the RA and students, and pose no risk to participants. Parents will 
be asked to provide information about their adolescent’s food allergies prior to the first session. 
Substitutions for the foods used in preparation and in the taste tests will be made if a adolescent 
in the group has allergies so that all adolescents can participate and ensure that adolescents are 
not exposed to allergens. 
 
Potential risks associated with outcome measures. There are very few risks associated with 
completing the outcome measures.  The Test of Gross Motor Development-Third Edition 
(TGMD-3) poses no greater risk than the risks associated with the intervention itself, as 
described above.  
 
There are no discernable, unexpected risks in completing the survey/questionnaire-based 
measures. There are no risks associated with the measures of food preparation skills, healthy 
food knowledge, or healthy eating behavior. 
 
17. POTENTIAL DIRECT BENEFITS TO SUBJECTS* 
Participants may benefit from the intervention by increasing their physical literacy including 
movement skills, physical self-concept and desire to participate in sports/physical activities, and 
food literacy including healthy eating knowledge, basic food preparation skills, and improved 
healthy eating behavior. They may also benefit by participating in an enjoyable group-based 
intervention with their peers. However, these benefits cannot be guaranteed. 
 
18. VULNERABLE POPULATIONS* 
All participants in the project will be adolescents ages 12-16 years with an intellectual disability.   
 
We will obtain consent from a primary caregiver (i.e., father, mother, guardian); in the case of 
divorce, we will obtain consent from the both parents if they have joint legal custody, or the 
parent who has sole legal custody.  In the case where the adolescent is under the care of an 
agency such as the Department or Children and Families, we will seek permission/consent from 
the responsible party at the agency.   Adolescents who have guardianship other than their parents 
will be required to provide written proof of their authority to grant permission for the adolescent 
to participate in activities such as research (or to receive medical care).  
 
With the assent process, we will develop a simply worded document which we will read/review 
with the adolescent and invite them to ask questions.  If they indicate an interest in participating, 
we will ask them to sign their name to the form.  If they indicate that they do not wish to 
participate, we will try to ascertain their concerns and allay them, but if their unwillingness 
persists, we will not proceed with enrolling them in the program, and will make it clear to them 
that this is a choice that they have the right to make.  We have used these procedures in the past 
with this population and have had good success. 
 

 
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19. MULTI-SITE RESEARCH*  N/A 
 
20. COMMUNITY-BASED PARTICIPATORY RESEARCH*  N/A 
 
21. SHARING OF RESEARCH RESULTS WITH SUBJECTS* 
Upon completing the study, analyzing the results, and publishing the main paper(s) from the 
intervention, we will write to participants to provide them with a lay description of the findings 
and to give them references to the published papers. 
 
22. SETTING 
The project will be carried out at the E.K. Shriver Center at UMass Chan Medical School, 
although the intervention itself will be conducted remotely using Zoom. 
 
23. RESOURCES AVAILABLE 
The study team consists of researchers and personnel from University of Massachusetts Chan 
Medical School Eunice Kennedy Shriver Center, University of Massachusetts Boston (UMass 
Boston), Merrimack College, and Tufts University School of Medicine (TUSM) who will work 
collaboratively on this clinical trial.   
 
Principal Investigator is a well-established health researcher with a focus on obesity prevention 
and treatment through tailored interventions for youth with intellectual and developmental 
disabilities. She will oversee the entire project and ensure that it is carried out according to the 
approved protocol and established timelines.  She will manage the collaborative efforts among 
the Co-Investigators and will coordinate the weekly meetings of the research team.  The PI will 
also be responsible for supervising the work of the Project Coordinator and Research Assistant.  
She will oversee the recruitment, interactions with the IRB, and will be responsible for the 
budgetary aspects of the grant. The PI will direct the development of the satisfaction and 
enjoyment questionnaires to test the feasibility of the intervention, and will oversee the collection 
of the psychosocial data (i.e. confidence, perceived competence).  She will work with the Co-
Investigators, and the Data Analyst on data interpretation, manuscript preparation, and 
dissemination.  The PI will devote 10%FTE in both Years 1 and 2 of the project. 
 
Co-Investigators  
The Co-Investigators involved in the project are PhD-level investigators and accomplished 
researchers in the fields of nutrition and physical activity in children and youth with ASD/IDD.  
The co-investigators will work with the PI to carry out the project and will each oversee the 
following aspects of the project according to their areas of expertise: (1) development of the 
physical activity and food literacy curricula and the preparation of the related materials and 
resources; (2) supervise and support program interventionists; (3) oversee data collection, 
analysis, and interpretation; and (4) assist with manuscript preparation and dissemination.  Co-
investigators may also be involved in participant consenting activities, and other intervention-
related interactions with participants and their family members. They will participate between 
4% and10%FTE in Years 1 and 2 of the project.  
 
Project Coordinator (PC) will be responsible for working with the PI and the research team to 
support the implementation and evaluation of the physical and food literacy intervention.  The 

 
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Project Coordinator will work with the research team to develop the REDCap database for 
participant tracking and data entry.  S/he will oversee data entry and data management activities 
and record-keeping.  S/he will also work closely with the PI, Co-Investigators, Research 
Assistant, and other research staff to ensure the data are managed according to protocol.  The PC 
will participate in data interpretation and dissemination activities.  S/he will also coordinate 
communications with the IRB. S/he will participate on the project for 30% FTE in Year 1 and 
28% FTE in Year 2.  
 
Research Assistant The Research Assistant will assist with recruiting participants, coordinating 
screening/enrollment and intervention visits, coordinating communications with 
parents/participants, and coordinating fiscal aspects of the program (e.g., invoicing for study 
sites, track instructor hours, purchase supplies, etc.).  S/he will also assist and support the 
Physical Activity Instructor and Nutritionist during the intervention sessions to ensure that they 
are implemented according to the approved protocol.  The Research Assistant will coordinate 
and assist with data collection of physical and food literacy skills under the supervision of the 
Co-Investigators.  The Research Assistant will attend weekly meetings with research team and 
assist with day to day project-related tasks. S/he will participate 100% FTE in both Years 1 and 2 
of the project.  
 
Physical Activity Instructor will be an individual with prior experience delivering physical 
activity/sport programming to youth with disabilities.  S/he will work with the research team, 
under direct supervision of one of the Co-Is to develop and adapt the overall physical literacy 
curriculum and design the activity plans for the weekly sessions.  The Instructor will lead and 
supervise the weekly physical activity/sport sessions for the 12-week intervention and will 
oversee and support the student assistants during the activity sessions.  The Instructor will have 
regular meetings with the research team to ensure that the intervention is being implemented as 
planned and to develop strategies to adapt the curriculum and pedagogy as needed.  The Physical 
Activity Instructor will also support and assist the Nutritionist in the weekly food literacy 
activities as needed.  The PA Instructor will participate 5 hours/week for 19 weeks, Years 1 & 2.   
 
Nutritionist will work with the research team under the direct supervision of on of the Co-Is to 
develop the food literacy curriculum and design the activity plans for the weekly sessions.  The 
Nutritionist will be responsible for preparing the materials for the weekly lessons, including the 
food for the taste tests.  S/he will lead and supervise the weekly food literacy activities over the 
12-week intervention and will oversee and support the student assistants during the food literacy 
activities.  The Nutritionist will also support and assist the Physical Activity Instructor in the 
physical literacy activities as needed.  The Nutritionist will have regular meetings with the 
research team to ensure that the intervention is being implemented as planned. The Nutritionist 
will participate 5 hours/week for 19 weeks, Years 1 & 2. 
 
Data Analyst will work under the supervision of one of the Co-Is to assist with data 
management and will implement statistical programming relevant to testing the study hypotheses 
and for quality control.  S/he will participate in data interpretation and manuscript preparation 
activities, and will have extensive experience in data management and statistical analyses.   
 

 
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Graduate Students from Boston University will work under the supervision of the PI and Co-Is 
to implement the project, including offering support during the sessions and conducting short 
activities in breakout rooms. 
 
24. LOCAL RECRUITMENT METHODS 
 
Recruitment. 
 
Participants with ID will be recruited through area special education programs and schools, as 
well as through the many agencies that serve individuals with ID and their families such as local 
Arc chapters, city/town recreation programs, Federation for Children with Special Needs, MA 
Down Syndrome Congress, Department of Developmental Services, and MA Special Education 
Parent Advisory Councils. We will use our extensive connections in the community and the 
UMass Chan E.K. Shriver Center’s database of participants from previous studies to reach 
adolescents with ID. We aim to recruit a racially/ethnically diverse sample via postings to 
listservs, websites, phone, paper mailings, newsletters, and word of mouth. IRB-approved 
recruitment will be conducted locally using materials that are mailed or distributed via social 
media to organizations that serve youth with ID.  We will continue to submit all recruitment 
materials via a modification prior to utilizing the recruitment material. 
 
Recruitment materials (e.g. e-brochures, electronic messages) will clearly outline the details of 
the study and a parent/guardian will directly contact the research staff by telephone or email to 
express their interest in having their child participating. The intervention will be marketed as a 
non-competitive and engaging program involving sport skills sampling and healthy eating 
awareness activities to build physical literacy and food literacy. 
 
Our research plan allows for a 10% drop out rate, which is supported by our previous work in 
which we have had over 95% retention rates in several intervention studies.  
 
Recruitment – Inclusion/Exclusion Criteria 
We will recruit 30 male (n=15) and female (n=15) adolescents with intellectual disabilities (ID) 
ages 12-16 years. Because the etiology of ID is variable with many known and unknown causes, 
we expect the sample will include adolescents with various syndromes such as Down syndrome, 
Fragile X, Williams syndrome, as well as adolescents with ID of unknown etiology. To be 
included in the study adolescents will be required to have IQ and adaptive functioning scores of 
≤75 as measured by the Kaufman Brief Intelligence Test-2 and Vineland Adaptive Behavior 
Scales-III. Participants must be independently ambulatory and in sufficiently good health to 
engage in moderate-to-vigorous physical activity, and be able to communicate verbally in 
English, follow simple instructions, and provide assent/consent. Approval from the primary care 
physician and medical specialists (as necessary) will be required for participation. 
 
Exclusion criteria include: 1) uncontrolled medical or significant psychiatric condition; 2) 
insulin-dependent diabetes; 3) physical/orthopedic impairment that would preclude safe 
participation in physical activity; 4) legally blind or deaf; 5) habitual problem behaviors such as 
aggression or noncompliance 
 

 
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Screening 
Adolescents with ID will be initially screened for eligibility for the study via a telephone or 
Zoom interview with a parent by the Project Coordinator. During the interview, the intervention 
will be described and the concepts of physical literacy and food literacy will be explained to 
parents. Those adolescents who meet the inclusion criteria and a parent will then participate in an 
enrollment meeting via Zoom. During that meeting, the study protocol will be reviewed in detail 
and parental permission/informed consent will be obtained and adolescents will sign an assent 
from that will be administered in the form of a social story. After the consenting and assenting 
process, we will administer the KBIT-2 to confirm IQ eligibility (i.e., ≤75) and administer the 
VABS-III to determine if the adolescent meets the criteria for ID (i.e., ≤75) based on their 
adaptive behavior. If the adolescent meets criteria, demographic characteristics will be 
ascertained via parent questionnaire on age, sex, race/ethnicity and parent education. 
 
Data management 
The names of the participants will be obtained to ensure that the data are organized during data 
collection and for the intervention. Names will be transferred to a participant number when the 
data are entered into the computer and no names will ever be published. Age and birthdate will 
also be required as will sex. The addresses and telephone numbers of the parent(s) of each 
participant will be required in order to maintain contact during the intervention. There will be no 
attempt to link the personal identification information to the study data.   Data from participants 
who screened but did not enroll will not be included as study data, except to track information as 
needed for a Consort diagram. Their identifying information will be destroyed/deleted upon the 
start of the intervention, unless they have indicated a desire to be contacted for future research 
opportunities.   Anyone who indicates a desire to be contacted for future research opportunities 
will have their information shared with the Clinical & Translational Research Support Core at 
the Shriver Center that maintains a database of participant information for the purposes of 
recruitment (Curtin, PI).  This information is housed in a password protected database that is 
available only to Core staff. 
 
Recruitment Materials 
We will continue to submit recruitment material via a protocol modification prior to utilizing. 
 
Compensation 
Participants will not receive compensation for participation, but will be permitted to keep the 
sports equipment (e.g., balls, bats, etc.), and tablet after the intervention. If a participant does not 
have reliable internet, they will be provided with a Wi-Fi hotspot, which they will also be 
permitted to keep (however, we will not continue to pay for data service). 
 
25. LOCAL NUMBER OF SUBJECTS 
We will recruit 30 male (n=15) and female (n=15) adolescents with intellectual disabilities (ID) 
ages 12-16 years. 
 
26. CONFIDENTIALITY  
Confidentiality of participants will be protected in several ways. All participants will receive an 
identifying number for coding and analyzing data. Informed consent and identifying code 
numbers will be kept in a separate file from completed data questionnaires. Data will be reported 

 
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in group format only; if any need should arise to report individual data, it will be accessible only 
to the research team and identifying information will not be reported that might allow the 
individual’s identity to be discerned.  
 
Data will consist of a recording of and performance on the TGMD-3 test, completion of 
questionnaires by participants and parents, and recording of the virtual intervention sessions on 
Zoom.  All video recordings will be stored in a password-protected, HIPAA-compliant, cloud-
based server. Questionnaires will be administered by paper or electronically using REDCap. All 
paper-based data will be kept in a locked file cabinet and will be accessible only to the research 
team. Individual names and identifying characteristics will not be shared with others outside of 
the research team. Requests or discussions regarding participation in the study will be made by 
letter or phone calls in a separate, private room.  
 
Subjects will be provided with an Amazon Fire Tablet for use during the study. No identifying 
information will be stored on these devices during the duration of the study however we will 
allow participants to keep these devises after the intervention at which point they can choose to 
disclose personal information. The privacy statement for the Amazon Fire tablets can be found 
here: https://www.amazon.com/gp/help/customer/display.html?  
 
Additionally, this study will utilize the Remind App to provide SMS reminders of study tasks to 
participants’ parents. Remind was originally designed to facilitate communication, including 
texting, emailing and phone calls, from educators to students without sharing personal contact 
information. Remind is now commonly used in research to facilitate communication between 
research staff and participants or participants’ caregivers if applicable. Remind complies with all 
privacy laws applicable to public schools including FERPA and COPPA. Remind is ISO 
27001:2013 certified and has also obtained iKeepSafe certification for the FERPA Assessment,  
COPPA Safe Harbor Program, and California Student Privacy Badge. Remind is a certified 
signatory of Privacy Shield, administered by the US Department of Commerce, which allows 
Remind to lawfully transfer the data of European Union residents to the United States. To meet 
these program guidelines, Remind employs two kinds of security features: those that are user-
facing, and those that are embedded in the service. Users can receive messages via text message, 
smartphone app, or email, but contact information like phone numbers and email addresses are 
only visible to research administrators and not exposed to other parents or participants. Instead, 
Remind uses third-party phone numbers to protect users’ privacy.  
 
If participants opt-out of using the Remind app, we will ask them to consent to receiving 
notifications about the study via email or text message with the provided Text Message / Email 
Consent document. 
 
Describe the steps that will be taken to secure data and/or specimens during data collection, 
storage, use, and transmission. For example:  
• Which staff roles will be responsible for their receipt or transmission? 
How will they be collected and transported?  
The Research Assistant will be responsible for the receipt and transmission of the data 
and for transporting it by vehicle. Any transported data will be kept in a locked container 
while it’s being transported. 

 
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• Where and how will they be stored?  
How long will they be stored? 
Will any portable devices (e.g., laptops, thumb drives) be used? 
All data will be kept in a locked file cabinet accessible only to the research team and 
UMass Chan IRB representatives, on password-protected computers and in REDCap. 
Data will be stored for 5 years from the completion of the study. Laptops and thumb 
drives will be used and will be encrypted per UMass Chan policies. 
 
• Which staff roles will have access?  
All study staff will have access to the data.    
 
• How will you limit access?  
Only study staff will have keys to the file cabinets and passwords to the computers and 
REDCap. 
 
• Will staff undergo any special training or require special authorizations?  
No, this will not be necessary, as the procedures followed in this protocol are standard 
procedures for projects of this nature. 
 
• Will you implement electronic controls, such as password protection? Encryption?  
Yes – drives and databases (REDCap) will be password protected, and laptops/thumb 
drives will be encrypted. 
 
• Will you use physical controls, such as locked offices?  
Yes – all paper-based forms will be stored in locked cabinets within locked offices. 
 
• If data or specimens are coded, how will you store the key that links the code to subject 
identifiers separately from the data and specimens?  
The key that links the code to subject identifiers will be stored in REDCap, separate from 
the data.  
 
• When and how will you securely destroy identifiers to anonymize data?  
In order to securely destroy identifiers to anonymize data, we will remove the study code 
from the database that links the participant’s name to the study code.  This will be done 
within 5 years of study completion. 
 
• When and how will you securely destroy the data and specimens in full?    
All coded, printed data will be shredded 5 years from the completion of the study.  All 
electronic, coded data will be destroyed 5 years from the completion of the study using 
the most secure methods at that time, in order to make sure the data is completely 
destroyed.     
 
• Have you obtained or will you seek a Certificate of Confidentiality?  
 
No 

 
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Research personnel from University of Massachusetts Chan Medical School Eunice Kennedy 
Shriver Center, Tufts University, Boston University, and the University of Massachusetts-Boston 
who are listed with the IRB as UMass personnel engaged in the design, conduct, or reporting of 
the research will have access to local data.  In addition, people that have an identified role in 
oversight of this study may inspect subjects’ medical and research records.  This includes the 
National Institute of Health (NIH), the UMass Chan Institutional Review Board (IRB), and 
UMass representatives. Finally, PHI may be entered into databases at the University of 
Massachusetts Chan Medical School, including the Institutional Review Board (IRB), the 
Medical School’s research management system and the research, billing and compliance office. 
 
27. PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF SUBJECTS 
Participants and their parents will be interviewed to ensure that they understand the intervention, 
its purpose, and the information to be collected.  Ample time will be given to provide 
participants an opportunity to ask questions and express any concerns.  If it appears that the 
adolescent participants are reluctant to participate (even if their parents wish them to), we will 
make it clear that their agreement to be involved is key, and we will not proceed with enrolling 
them if it is apparent that they are resistant.  We will explain this to the parents and let them 
know that it would not be in their child’s best interest, or in line with research ethics, to involve 
them in the study without their full agreement. 
 
28. COMPENSATION FOR RESEARCH-RELATED INJURY 
N/A – This project does not pose more than minimal risk to participants. 
 
29. ECONOMIC BURDEN TO SUBJECTS 
There is very little economic burden to the subjects.  All materials and equipment will be 
covered by the study. 
 
30. CONSENT PROCESS 
Potential participants who meet the inclusion criteria and a parent will be invited to a remote 
enrollment meeting with the Project Coordinator. At that meeting, the purpose of the study will 
be explained in detail and we will interview the adolescent to discern their interest and 
motivation for participating in the program. Parental permission/informed consent will be 
obtained from parents and assent will be obtained from adolescents. The assent form will be 
verbally administered in the form of a social story over Zoom to accommodate potential limited 
reading skills of participants. The adolescent will then be asked to verbally assent to the study, 
with that verbal assent being documented in REDCap. A parent will be present for the assenting 
process to help ensure that adolescents with ID understand the details of the study and what they 
are agreeing to. Participants may elect to decline participation at any point during the project, 
even after giving informed assent, as described above.   
 
31. PROCESS TO DOCUMENT CONSENT IN WRITING 
As indicated above, we will obtain written consent from parents and a simple signed assent from 
the adolescents/youth. 
 
32. DRUGS OR DEVICES – N/A