FUEL: Food, fUn, frEsh, famiLy Program. Improving Children's Diet Through Afterschool Program and Family Support.
Phase: NA
Conditions: Diet, Healthy Growth
Sponsor: University of Texas at Austin

 
FORM: IRB Proposal - Standard Submission 
NUMBER 
VERSION DATE 
HRP-UT901 
11/1/2022 
 
 
Page 1 of 37 
 
 
ClinicalTrials.gov Cover page 
 
Official Title of the study 
FUEL: Food, fUn, frEsh, famiLy program. Promoting children’s diet through afterschool program 
and family support. 
 
NCT number  
NCT06010784 
 
Date of the document 
August 24, 2023 
 
Unique Protocol ID: 
STUDY00004545 
 
 
 

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INSTRUCTIONS 
• 
This form is only for studies that are considered greater than minimal risk (full board) or qualify for expedited 
review (fits in one or more expedited review categories). See section 5.3 of the UT IRB Policies and Procedures 
Manual for details regarding expedited research.  
• 
Do NOT submit this form if the study will qualify for exempt review. If your study is exempt, submit HRP-UT902 
Template IRB Proposal Exempt Submission. You can download proposal templates from the Templates tab in 
UTRMS-IRB Library.  
• 
If you are only using secondary data that will not be initially collected solely for this research project, do not 
complete this form. Instead, use HRP-UT903 Template IRB Proposal Secondary Use form instead. You can download 
proposal templates from the Templates tab in UTRMS-IRB Library. 
• 
For studies following a sponsor protocol, please use this guidance to assist in your completion of this form.  
• 
Answer all questions. If a question is not applicable to the research or if you believe you have already answered a 
question elsewhere in the application, state “NA” (and if applicable, refer to the question where you provided the 
information). If you do not answer a question, the IRB does not know whether the question was overlooked or 
whether it is not applicable. This may result in unnecessary “back and forth” for clarification. Use non-technical 
language as much as possible.  
• 
To check a box, click on the check box (or double click and type an “X” if using Google Docs). Please note, Word 
online does not support Word checkboxes. Please download the file and use your desktop version of Microsoft 
Word. 
• 
To fill in a text box, make sure your cursor is within the grey text box before typing or pasting text.  
• 
Do not convert this Word document to PDF. The ability for UTRMS-IRB to implement “tracked changes” is required 
to facilitate efficient review. 
 
INDEX 
General Study Information  
Screening & Recruitment  
Required Disclosures 
Study Element Identification  
Obtaining Informed Consent  
Privacy & Confidentiality  
Study Procedure Description 
Benefits  
Compensation & Costs 
Subject Population  
Risks 
 
 
 
 

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GENERAL STUDY INFORMATION 
 
Study Title  
 
Include the study title below.  
 
FUEL: Food, fUn, frEsh, famiLy program. Promoting children’s diet through afterschool program and 
family support. 
 
 
1 
Review Type (Choose one) 
 
Please choose which level of review best fits your research. This is an investigator’s assessment of review and 
does not preclude the IRB from alternate determinations. In cases where the investigator and the IRB’s 
determination of review conflict, the IRB’s determination will be considered the official determination.  
 
Note: Expedited review does not refer to the timeliness of the review of your protocol, but specific categories of 
research defined by OHRP. If you would like help determining which type of review best fits your research study, 
please contact the IRB staff in the Office of Research Support & Compliance: 
https://research.utexas.edu/ors/human-subjects/get-help/  
 
a ☐ 
 
Full Board Review – Greater than Minimal Risk Research 
b ☒ 
 
Expedited Review – Minimal Risk Research  
 
2 
Research Hypotheses 
Please describe the research aims and hypotheses in the box below. To input text, click in the box below and 
start typing.  
Note: Procedures will be explained in a separate section below. 
 
 
 
Our primary hypothesis is that the effect of an after-school curriculum on nutrition and physical 
activity for elementary aged children improves overall child diet better when resources to encourage 
healthier eating are provided to caregivers at the same time than if they are not provided.  
 
 
 
3 
Study Background 
Provide the rationale and the scientific or scholarly background for the proposed activity, based on existing 
literature (or clinical knowledge). Describe the gaps in current knowledge that the project is intended to address. 
 
 
One approach to improving child health trajectories including diet has focused on after-school 
programming. A prominent example, the “Coordinated Approach to Child Health” (CATCH) program, 
provides curriculum on nutrition and physical activity. CATCH has, over almost two decades of 
implementation and assessment, shown positive impacts on reducing the incidence of obesity and 
improving child diet (Hoelscher et al, 2010).  It is regularly used by organizations such as the Boys and 

Page 4 of 37 
 
Girls Clubs as part of after-school programming.  In addition to the core program for children, parental 
and community involvement and family support have been shown to improve outcomes when added 
to such after-school programming (Brown et al, 2019). However, family support is not a standard part 
of such programs today. 
 
Although family support is not simple to implement, there are a variety of approaches of providing 
family support that can layer onto after-school programming and might enhance results for the child.  
For example, fruit and Vegetable (VF) vouchers provided to parents and caregivers as “prescriptions” 
during clinic visits have resulted in modest improvements in child diet (Ridberg et al, 2019, Saxe-
Custack, et al 2021).  In 2021 our laboratory implemented and tested a brief program to provide 
resources to caregivers to see if that might help them support their children in improving diet.  In 
partnership with the Boys and Girls Clubs of the Austin Area (BGCAA), we piloted a 4-week 
intervention for improving Elementary school age child diet by providing weekly a 10-lbs FV box and a 
$10 grocery store gift card to the BGCAA’s pandemic protocol of curbside distribution of resources 
(Kahlon et al., 2022). The weekly FV boxes included customized recipes and cooking tips.  An incentive 
was added for 3 weeks, where caregiver completion of a brief goals sheet provided an additional $10 
gift card weekly.  Child and caregiver diet were assessed at 4 weeks at the end of the program and 
after another 4 weeks, as follow-up. A randomized trial provided families with the program as 
described above (intervention) or at the end of 8 weeks with grocery store cards of equivalent value 
(control). Child diet was assessed by the validated Texas School Physical Activity and Nutrition, SPAN, 
and children in the intervention arm relative to those in the control arm showed statistically significant 
dose-dependent improvements in overall diet and in fruit and vegetable intake at 4 weeks, and 
sustained at 8 weeks.  
 
Here we assess: 
(1) Can we improve the effects of an evidence-based after-school program that focuses on 
nutritional education and physical activity by adding family support in the format we showed 
previously to be beneficial by itself. We will assess the incremental benefit of adding family 
support to allow caregivers some financial flexibility to help their children try healthier foods 
such as fruits and vegetables.  We will compare the addition of family support with a 
randomized control group that does not receive the family support but is still in the same after-
school program.   
 
To aid our research, we have built a partnership for implementation with the Boys and Girls Club of the 
Austin Area (BGCAA).  In addition, one of the original designers and frequent assessor of the evidence-
based after-school program from the UT School of Public Health at Austin is our collaborator. 
 
References 
Brown T, Moore THM, Hooper L, Gao Y, Zayegh A, Ijaz S, Elwenspoek M, Foxen SC, Magee L, O'Malley C, Waters E, 
Summerbell CD. Interventions for preventing obesity in children. Cochrane Database of Systematic Reviews 2019, 
Issue 7. Art. No.: CD001871. DOI: 10.1002/14651858.CD001871.pub4. Accessed 11 May 2023. 
Kahlon MK, Aksan NS, Aubrey R, et al. Effect of Brief Produce Exposure and Unconstrained Grocery Gift Cards on Caregiver 
Influence on Diet of Elementary Age Children: A Randomized Clinical Trial. JAMA Netw Open. 2022;5(5):e2212973. 
doi:10.1001/jamanetworkopen.2022.12973. 
Hoelscher DM, Springer AE, Ranjit N, et al. Reductions in child obesity among disadvantaged school children with 
community involvement: the Travis County CATCH Trial. Obesity. 2010;18(S1):S36-44. 
Olsho L EW, Klerman J A, Wilde P E, Bartlett S. Financial incentives increase fruit and vegetable intake among Supplemental 
Nutrition Assistance Program participants: a randomized controlled trial of the USDA healthy incentives pilot. Am J 
Clin Nutr. 2016;104(2):423-35. doi:10.3945/ajcn.115.129320. 

Page 5 of 37 
 
Ridberg R A, Bell J F, Merritt K E, Harris D M, Young H M, Tancredi D J. Effect of a fruit and vegetable prescription program 
on children’s fruit and vegetable consumption. Prev Chronic Dis. 2019;16(73):180555. doi:10.5888/pcd16.180555. 
Saxe-Custack A, Lachance J, Jess J, Hanna-Attisha M. Influence of a pediatric fruit and vegetable prescription program on 
child dietary patterns and food security. Nutrients. 2021;13(8). doi:10.3390/nu13082619 
 
 
 
4 
Design and Methodology 
 
Provide a brief description of the study design or data collection methodologies. Details regarding protocol 
specific research procedures will be discussed in a later section. 
 
 
Design: A two-arm randomized trial. 
 
Randomization: 
• Eligible households with at least one child (reference child) in the BGCAA after-school program 
whose caregiver/parent (guardian) (reference caregiver) consents to participate in the study 
will be randomized to either the active intervention or the control (1:1 ratio). Randomization 
will be stratified by the family’s SNAP beneficiary status as SNAP could affect uptake of 
treatment elements offered in the family support arm.  
 
 
Blinding: Outcome assessors, principal investigator, and biostatistician are blinded to participant 
allocation. Participant and other staff are unblinded.  
 
Study arms (19 weeks) (Figure 1): 
 
Randomized arms 
Children in both intervention and control arms participate in the BGCAA’s after-school program with 
CATCH curriculum. 
1. Across participating school sites, the whole BGCAA’s after-school program runs for 3h, Mon-Fri for 
the school year. Children enrolled are expected to attend a minimum of 2x/week. 
2. CATCH curriculum will be delivered as a component of the after-school program in blocks of 45-60 
min, twice a week. 
3. Children also participate in active recreational time (approx. 60 min, offered 1x/week at a 
minimum) which consists of a mixture of free play, structured physical activity games, and/or 
sports activities (including soccer, football, and basketball). 
 
Intervention arm: BGCAA after-school program + Family support 
1. Children participate in the BGCAA’s after-school program with CATCH curriculum as 
described above. 
2. The child’s caregiver will receive the following: 
• Family tip sheets sent via mobile text at the start of the program and then every 3 
weeks, to a total of 6 txt messages. 
• Weeks 1-4 (4 weeks): 
i. Welcome package mailed to the family’s residence approximately in the first week 
of the program.  

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ii. Weekly: 1 box of produce 
iii. Recipes accompanying each box (sample recipe card attached to submission) 
iv. Bi-Weekly: Grocery store gift cards (2x $20, to a total of $40) 
• Weeks 5-19 (total of 10 weeks over the 19-week study timeline): 
i. For five weeks, an optional online form (or “goal sheet”) will be sent to the 
parent/caregiver (5 sheets in total) with questions about trying new FV items to be 
completed within the next 7 days. As an incentive, a $10 gift card will be sent the 
following week to those who complete it (a potential total of $50). 
ii. Week 11: $20 Grocery store gift card. Based on disruptions due to the school year 
breaks, we will provide an extra $20 gift card to re-engage the week after a school 
holiday. 
 
Control arm: BGCAA after-school program only 
1. Children participate in the BGCAA’s after-school program with CATCH curriculum as 
described above. 
2. At the end of the study, they will receive $120 as grocery store gift cards. 
 
 
 
Figure 1. Study design: 2 randomized arms 
 
Outcomes:  
• Primary:  
o Child’s diet quality: measured by Healthy Eating Index, HEI, scores calculated from the 
Texas School Physical Activity and Nutrition (SPAN), 2nd Grade. 
o Child’s fruits and vegetable consumption, measured by SPAN, 2nd Grade. 
 
• Secondary outcomes:  
o Caregiver/parent diet quality, measured by HEI scores calculated from the SPAN, 8th 
Grade. 
o Child’s physical activity levels 
o Child’s body mass index, as percentile of BMI-for-age 
 

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Study measurements:  
Timepoint measurements for all study participants (child-parent dyads) include:  
• 
baseline (approximately up to 4 weeks prior to the first produce bag and grocery store gift card being 
distributed). Height and weight will be taken during the first 1-2 weeks of the research program start 
date during a BGCAA field day. 
• 
mid-point (planned for approximately weeks 5-8) 
• 
end-point (approximately between weeks 16 and 21). Height and weight will be taken during the 19th 
week of the program at the BGCAA’s field day. 
 
Outcomes 
Tool 
Time points 
Administration 
Child’s Diet (primary) 
TX SPAN 2nd grade 2019-
2020 – Dietary questions 
Baseline, Mid-point, End 
point 
Child, Guardian-reported 
Structured interview 
over the phone by RA 
SPAN Healthy Eating Index 
scores (includes total, 
healthy, and unhealthy 
scores) 
Baseline, Mid-point, End 
point 
Child, calculated from 
SPAN 
Physical Activity 
TX SPAN 2nd grade 2019-
2020 – Physical activity 
questions 
Baseline, End point 
Child, guardian-reported 
Structured interview 
over the phone by RA 
Physical Activity 
Questionnaire – Children  
Sedentary Behavior 
TX SPAN 2nd grade 2019-
2020 – Sedentary 
behavior questions  
Baseline, Mid-point, End 
point  
Child, guardian-reported 
Structured interview 
over the phone by RA  
Child’s mental health 
Strengths and Difficulties 
Questionnaire (SDQ) 
Baseline, Mid-point, End 
point 
Child, guardian-reported 
Structured interview 
over the phone by RA 
BMI-to-age 
 
 
 
Weight 
Weight scale 
Baseline, End point 
Intervention and control 
arms only: Measured by 
study staff 
Height 
Stadiometer 
Baseline, End point 
Intervention and control 
arms only: Measured, by 
study staff  
 
 
 
 
Parent/Guardian’s diet 
NHANES 2009-2010 
Dietary Screening 
Questionnaire 
Baseline, Mid-point, End 
point 
Parent, self-report 
Structured interview 
over the phone by RA 
Parent/guardian’s 
quality of life (physical/ 
mental) 
Short Form 12 (SF-12) 
Baseline, End point 
Parent, self-report 
Structured interview 
over the phone by RA 
 
Pop descriptors 
(Baseline only) 
Tool 
Administration 
Demographics & social 
needs (PRAPARE) 
Customized. Related to:  
1. parent/caregiver (age, gender, ethnicity, 
health insurance, work status, transportation 
and housing) 
Parent, Self-report 
Structured interview 
over the phone by RA 

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2. household (income, housing, program 
participation like SNAP, shopping and food 
prep) 
3. child (sex, DOB, health insurance, program 
participation like SLP or SBP, previous BGCAA 
programs) 
Food security 
USDA 6-items 
Parent, Self-report 
Structured interview 
over the phone by RA 
 
 
 
 
5 
Data Analysis 
Describe the data analysis plan, including any statistical procedures or power analysis. 
 
 
Because both the primary and secondary outcome measures are continuous, normally distributed 
measures, we anticipate having to rely on normal theory analytic methods. Specifically, mixed linear 
regressions on the primary (HEI) and secondary outcome measures (such as Fruits & Vegetable 
subscores, BMI and parent HEI) will be fitted to test differential trajectories for two groups from 
baseline to midpoint and end point assessment of the program, time expressed as days elapsed from 
baseline. These models readily accommodate differential dropout in the arms with maximum 
likelihood estimation, random intercepts, and also adjust for any clustering effect of the BGCAA sites.  
Because randomization will be stratified by whether the family are SNAP recipients or not, the main 
effect of family’s SNAP beneficiary status will be included in all models in addition to the main target 
terms of interest: two-way interactions of time X treatment, time X SNAP, and their three-way 
interaction. Overall alpha will be set at 0.05 for each child outcome on these target terms.  
 
In addition to these intention-to-treat (ITT) analyses we will also conduct as-treated (AT) analyses 
incorporating the ‘dose’ variable that will be formed based on implementation database elements that 
permits the tracking of program elements consumed/ picked up/ attended by the target child and 
his/her parent/guardian in the two active arms. In AT models, total dose taken-up by the end of the 
program will enter into product terms with time. As is typical, we expect the AT models to have 
greater sensitivity/ precision in estimating the added value of the family support beyond the elements 
of the after-school program with CATCH for change in HEI and secondary outcomes. In addition the 
dose variable sheds light on the effects of Boys and Girls Club programming, including CATCH, 
regardless of other incentives. Statistical controls for family demographic characteristics, food 
insecurity, child age, sex, and SNAP beneficiary status will be included in the AT framework as ‘dose’ is 
not completely controlled by the randomization and hence would be expected to be correlated with 
these characteristics (e.g. economically disadvantaged families may be more likely to uptake more of 
the program elements).  
 
The greatest opportunity lies in exploratory analyses of the two randomized arm participants that 
permit the estimation of dose-response based on family characteristics. Both the “after-school 
program with CATCH” and the “after-school program with CATCH + family support” intervention arms 
are expected to show variation in dose.  In the case of dose for “after-school program only” 

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participants, we expect dose variation to be predicted by structural characteristics of family routines 
(e.g. number of days the target child attends BCG after-school program is predicted by whether both 
parents are employed, family income, number of siblings and caretakers in the family as alternatives to 
BCG attendance). In contrast, dose for “after-school program with CATCH + family support” 
participants is more complex and includes distinct elements that require greater motivation on the 
part of the parent/ guardian to engage with (e.g. completing goal sheets and receiving incentives 
versus not completing incentivized elements of the program). We will model the associations of 
separate aspects of ‘dose’ with response (HEI, physical activity) and predict separate aspects of ‘dose’ 
from family characteristics at baseline. These exploratory analyses will provide clues on how to 
structure future programs, incentivize participation, as well as inform who is likely to benefit the most.  
In the exploratory analytic framework, we will engage in omnibus correction for inflations in type-I 
error rate and will not interpret any significant single result unless at least 10% of all examined 
associations are significant.  
 
STUDY ELEMENT IDENTIFICATION 
6 
Study Elements 
 
Check each research procedure included in your study. 
A full description of all study procedures should be provided in the Procedures (Details) section below.  
Procedures denoted with “*” below have supplemental forms. Navigate to the UTRMS-IRB Library, Templates 
tab to download the applicable supplemental form. 
 
 
 
☐ 
 
Bio-specimens* 
☒ 
 
Biometrics 
☐ 
 
Registry or Repository* 
 
☐ 
 
Focus Group 
☐ 
 
Genetic Analysis 
☐ 
 
Genomic Data Sharing 
 
☐ 
 
International 
Research* 
☒ 
 
Interview/Survey 
☐ 
 
MRI 
 
☐ 
 
Protected Health 
Information* 
☐ 
 
Observation 
☐ 
 
Radioactive Material/PET/Nuc. 
Med 
 
☐ 
 
Record Review 
☐ 
 
Sensors  
(Externally Placed) 
☐ 
 
Sensors  
(Inserted) 
 
☐ Audio (only) 
Recording 
☐ Video Recording 
 
☐ 
X-Ray/CT/DEXA 
 
 
 
7 
Study Intervention 
 
Click on the check box (or double click and type an “X” if using Google Docs) if you will implement any of the 
following interventions. 
A full description of all study interventions should be provided in the Procedures (Details) section below.  

Page 10 of 37 
 
* Interventions denoted with “*” below have supplemental forms. Navigate to the UTRMS-IRB Library, 
Templates tab to download the applicable supplemental form. 
 
 
☒ Behavioral 
☐ Device* 
☐ Drug/Biologic* 
 
 
8 
Clinical Trial  
 
Click on the following check box (or double click and type an “X” if using Google Docs) if the research meets the 
below definition of a clinical trial.  
 
 
 
☒ This study meets the definition of a clinical trial according to clinical trials.gov in 
that it involves one or more human subjects who are prospectively assigned to 
one or more interventions (which may include placebo or other control) to 
evaluate the effects of those interventions on health-related biomedical or 
behavioral outcomes. 
 
 
9 
Additional Oversight  
 
Check the box(es) below if you are implementing research procedures that require oversight from additional UT 
committees. 
 
 
 
☐ Energy introduced 
to the subject 
(electrical, 
magnetic, light) 
☐ Human embryonic, 
human induced 
pluripotent, or human 
totipotent stem cells; 
or human gametes or 
embryos 
☐ Radiation exposure without 
direct clinical benefit 
 
 
 
 
 
☐ Biological Samples, Biohazards, Recombinant DNA, or Gene Transfer  
 
 
If biological samples are used and stored on UT campus UT IBC approval is needed. 
 
a 
☐ 
UT IBC has (or will have) oversight.  
 
 
Provide UT IBC Number:  
 
 
      
 
 
 
 
 
b 
☐ 
Biological samples collected will not be stored at UT Austin and another 
agency has responsibility for biospecimen safety. 
 

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10 Alternatives to Participation in This Study 
Provide a description of alternatives to participation in this study, as applicable.  
 
Families who choose not to participate in the study will continue to benefit from their participation in 
the BGCAA after-school program, however, only families that choose to participate will receive the 
family support component. Those on waitlist control that do not choose to participate, will remain on 
the waitlist until they are accepted into the BGCAA after-school program.  
 
 
 
 
 
STUDY PROCEDURE DESCRIPTION  
11 Procedure Description 
 
Describe all study procedures, including a step-by-step outline of what participants will be asked to do or how 
data will be used. Be sure to describe all of the following in detail, as applicable:  
• 
Description of all research procedures being performed and when they are performed, in sequential 
order.  
• 
Describe/list all research measures/tests that will be used [NOTE: upload copies of all measures, 
surveys, scripts, data collection forms, etc., in “Other Attachments” in UTRMS-IRB].  
• 
Secondary data or specimens that will be obtained, how they are collected, how are they used.  
• 
Where research activities will take place and duration (include expected time commitment of 
participants).  
• 
Study elements checked in #6 above should be described here.  
Note: if this is a multi-site or collaborative study include the following:  
• 
This is a “Multi-site Study that involves more than one site performing ALL aspects of the research 
procedures as outlined above.” OR “This is a collaborative study that involves UT Austin researchers 
working with external researchers who are engaged in performing the following study activities (list 
activities).”  
• 
For assistance with multi-site/collaborative research, download HRP-UT932 Request to Rely 
Assessment Form from the UTRMS-IRB Library and email irbreliance@austin.utexas.edu. 
 
 
Recruitment and arm allocation 
1. Interest list  
a. BGCAA staff and Factor Health research staff (research associates, RAs) will use various 
methods (described in section 16) to identify interested participants. The name and 
contact of these potential participants will be put on a shared spreadsheet in UT Box and 
this will serve as the interest list that study members will use to recruit people into the 
program. The spreadsheet will only be shared between study staff.  
b. From tabling activities, we will collect people’s names and phone numbers and will add to 
the interest list. These tabling events will occur at BGCAA sites.  
2. Consent (caregiver/parent) + Assent (child)  

Page 12 of 37 
 
a. Interested participants will be called by study staff to screen and share consent and assent 
information, which is expected to last approximately 15 minutes. Consent and assent will 
be collected verbally in order to reduce burden on participating families.  
b. After RA obtains consent and assent, if time allows, will also gather baseline data over the 
phone on the same phone call. If time constraints exist, staff will schedule another time 
and date for baseline phone measurements (more below). 
3. Participating families (parent-child dyads) will then be allocated to study arms as follows: 
a. Dyads with one reference caregiver and one reference child in the BGCAA after-school 
program will be randomized to one of the two active arms (family support + after-school 
program, or after-school program only) 
 
Measurements and data collection procedures: 
 
There will be 3 data collection measurements over the course of 19 weeks. These are the baseline, 
mid-, and end-point measurements. The initial baseline phone call will take approximately an hour 
(counting consent/assent), while the mid- and end-point measurements will take approximately 45 
minutes to an hour. The height and weight measurements will take an additional 5 minutes. In total, 
participants can expect to spend approximately 4 hours of their time on study-related measurements 
and data collection.  
 
Data will be collected by members of study staff listed as study team members in UT-RMS. Data 
collection will only happen with the families that are actively participating and have consented in to 
the research, not the families participating in BGCAA’s regular program and not participating in our 
research study.  
 
Questionnaire data: 
At each measurement, the research associate (RA), blinded to the active study arm of the 
participants, will gather parent-reported data and child-reported data with parental guidance over 
the phone as structured interviews. The structured interviews will be done as follows: 
 
1. The RA places the phone call to the reference parent/caregiver. 
2. After introducing themselves and the purpose of the call, they will proceed with the 
questionnaires as shown in Section #4 (e.g., diet, physical activity, demographics). 
Questionnaires for children will be asked to the parent (guardian-reported) who can confirm 
answers with the child if they are present and as needed. At the parent’s discretion, the child 
may answer the questions themselves.  
3. After the children-geared survey answers are obtained, parent/caregiver will answer 
questions related to themselves and their diet.  
4. Answers will be recorded in real time in REDCap by the RA.  
 
Measured data (height and weight): 
Collected in the first week of the program (baseline) and in the last possible week of the program 
(end-point) in person for approximately 5 minutes, as follows:  
 
1. Children in the two randomized intervention and control arms: 

Page 13 of 37 
 
a. BGCAA staff and/or research study staff (blinded to the study arm allocation) at 
participating sites will embed weight and height measurements as part of their regular 
after-school activities during a field day. 
b. As part of the field day, all children will participate in an interactive activity that 
measures their weight, height and how high they can jump. Having all children 
participate in the activity will ensure participant and non-participant privacy. Height 
will be measured using a stadiometer against the wall before the activity. The activity 
will utilize athletic tape and/or post it notes that the children will write their name on 
and stick to a wall by jumping up. Prior to jumping, the child will stand on a mat with 
an integrated scale that will measure their weight. Both height and weight measures 
will be calculated for all children as part of Boys and Girls Club’s field day (non-study 
data), however, only the height and weight from the research participants will be 
collected and stored by Factor Health research staff (study data).  
c. The values of height and weight for the children participating in the study will then be 
scanned or typed in a secure and HIPAA-compliant database, such as UT Box.  
d. RAs involved in the study will then register them in REDCap for each child, both the 
original data and the transformed units (feet/inches for height and pounds for weight). 
 
This integration of height/weight measurements with the after-school day has been 
agreed to between study and BGCAA staff. Together we wish to minimize the direct 
and open measurement of weight since it is a sensitive activity for some children. In 
the experience of BGCAA staff contextualizing it in a more fun and instructional 
activity (as the above) would reduce the likelihood of causing them unnecessary 
psychological discomfort while still providing height and weight measurements. 
During consenting into the study, parents/caregivers will be fully and dully informed 
about this activity in which their child’s weight and height will be obtained. 
 
 
Interventions 
Arm #1 – Intervention arm: BGCAA after-school program + Family support 
• Children participate in the BGCAA’s after-school program with CATCH curriculum as well 
as other activities (such as active recreational time that could include sport activities such 
as soccer, basketball, etc, homework/power hour, and snack time) as they usually do. 
• Across school sites, the whole BGCAA’s after-school program runs for 2-3h, Mon-Fri. 
The after-school program happens immediately after school and BGCAA provides 
transportation from the school to offsite locations if the program is not held at 
child’s school.  
• CATCH (https://catch.org/) is a school-based program for health education and 
Whole Child wellness that BGCAA incorporates into their regular activities. BGCAA 
staff receives training (irrespective of the research) to focus on its healthy eating and 
healthy movement components. Each site’s BGCAA staff will deliver these 
components over the course of the school semester on the days of the week of their 
choice, with a minimum frequency of 45-60 min, twice a week. 
• Children participate in daily (M-F) recreational time (45-60 min) which consists of a 
mixture of free play, structured physical activity games, and/or sports activities 
(including soccer, football, and basketball as examples). 

Page 14 of 37 
 
4. The child’s parent will receive the following as part of a family support: 
• Approximately every 3 weeks (beginning in in Week 1), educational sheets (“tip 
sheets”) will be sent electronically via mobile text messages (total of 6). Sample tip 
sheet included as an attachment. 
• 1-4 (4 weeks): 
i. One welcome package will be mailed to the family’s address at the start of the 
program containing: A welcome letter, a calendar of important dates related to the 
program and some educational handouts such as healthy food choices with “Go, 
Slow, Whoa List”, tip sheets for activities, food allergy information, and child-
friendly recipes. Examples attached to this submission. Participant’s address will be 
obtained via the demographic questionnaire at baseline. 
ii. Weekly: 1 box of produce to be delivered centrally to each of the participating 
after-school sites and will be distributed by BGCAA to the participating 
parents/caregivers during child pickup. At the BGCAA housing sites, some children 
may walk home with the produce bag and a BGCAA staff member will assist if 
needed (which is normal protocol for BGCAA). Participants cannot pick the 
groceries that are provided, and therefore will not have control over potential 
allergens in the box. As such, participants with known food allergens related to 
produce items will be excluded from the study.  
iii. Recipes accompanying each box (sample recipe card attached to submission). 
Recipes will be the same for all participants and will be sent via a text message link.  
The program team will also provide physical copies of the recipes in the event they 
cannot access the text link. Bi-Weekly: HEB Grocery store gift cards (total of $40) 
• Weeks 5-16 (total of 10 weeks over the 19-week study timeline): 
i. At the start of weeks 5, 7, 9, 12, and 14: An optional online form (or “goal sheet”) 
will be sent to the parent/caregiver (5 sheets in total) with questions about the 
produce items (including but not limited to: bananas, carrots, zucchini, squash, 
etc.) they received to be completed within the next 7 days. As an incentive, a $10 
HEB gift card will be sent the following week to those who complete it (a potential 
total of $50). 
ii. Week 11: $20 HEB Grocery store gift card 
 
Since the goal sheet will contain identifiers (such as names), this form will be built in a HIPAA 
compliant database, such as REDCap, Qualtrics, or other secure database where the 
information collected will be securely stored and then checked by unblinded Factor health 
staff for appropriate incentive distribution.  
 
Arm #2 – Control arm: BGCAA after-school program only 
• Children participate in the BGCAA’s after-school program with CATCH curriculum as well 
as other activities (such as active recreational time, homework/power hour, and snack 
time)—as described for Arm #1. 
• Children participate in daily (M-F) recreational time (45-60 min) which consists of a 
mixture of free play, structured physical activity games, and/or sports activities (including 
soccer, football, and basketball). 

Page 15 of 37 
 
• They will be attending the same sites as the intervention arm (Arm #1). Hence, they will 
be exposed to the same after-school content at each participating site. 
• The after-school program happens immediately after school and BGCAA provides 
transportation from the school to offsite locations if the program is not held at child’s 
school. 
• At the end of the study, the reference parent will receive $120 as HEB grocery store gift 
cards, independently of their end-point measurement being obtained.  
 
 
 
. 
 
 
SUBJECT POPULATION 
 
12 
Protected Subject Populations 
Click on the check box (or double click and type an “X” if using Google Docs) each population, if they are 
specifically studied for this research. 
 
 
☐ 
 
Active Military 
Personnel 
☒ 
 
Children/Minors 
☐ 
 
Decisionally Impaired Adults 
 
☐ 
 
Emancipated Minors ☐ 
 
Fetuses 
☒ 
 
Individuals with Limited 
English Proficiency 
 
☐ 
 
Neonates (Uncertain 
Viability) 
☐ 
 
Neonates (Non-
Viable) 
☐ 
 
Prisoners 
 
☐ 
 
Pregnant Women 
☐ 
 
UT Staff/Employees 
 
 
☐ 
 
UT Students 
 
 
13 Research Participant Information 
Describe the general characteristics of the subject populations or groups including gender, health status, and 
any other relevant characteristics. If you have multiple research populations (e.g., teachers and students), 
clearly outline characteristics for each group. 
 
 
A household will be the subject of randomization, one index parent/caregiver and one index child 
(parent-child dyads) who meet inclusion criteria will be invited to participate in the research activities 
(data collection). 
Participation in the BGCAA after-school program is governed by that organization according to their 
mandate. 
 
 

Page 16 of 37 
 
b Minimum Age 
Include the minimum age range for target population. If you have multiple research populations (e.g., teachers 
and students), clearly state the minimum age for each group.  
 
Children in 1st grade (approx. 6 yrs old); 18 for adult participants (parents)  
 
 
c Maximum Age 
Include the maximum age range for target population. If you have multiple research populations (e.g., teachers 
and students), clearly state maximum age for each group. 
 
Children in 5th grade (approx. 11 yrs old); No maximum age for adult participants (parents)  
 
 
d Inclusion Criteria 
Describe the specific criteria that will be used to decide who will be INCLUDED in the research from interested or 
potential subjects. Define technical terms in lay language, as applicable. 
 
Parent must be 18 years or older. Child must be enrolled in grade 1 to 5 (aged approx. 6-11 y-o) for 
the 2023-2024 school year at one of the 11 sites where BGCAA offers after-school program to 
elementary-aged children, AND: 
• For intervention and control arms: Participating in the BGCAA after-school program at the 
beginning of the 2023-24 fall semester. Families participating in the BGCAA after-school 
program will be known at the start of the 2023-2024 school year.  
 
Participating families must be English and/or Spanish speaking and have the ability to receive text 
messages 
 
Locations where BGCAA offers after-school programming include:  
• Elementary schools:  
o NYOS (Not Your Ordinary School)  
o Woolridge Elementary  
o Overton Elementary  
o Walnut Creek Elementary  
o IDEA – Rundberg  
o McBee Elementary  
• Off-site locations  
o Home Club (BGCAA’s headquarters) 
o Meadowbrook Apartments (Housing Authority) 
o Booker T. Washington Court (Housing Authority)  
o Chalmers Court (Housing Authority)  
 
 
e Exclusion Criteria 

Page 17 of 37 
 
 
 
Describe the specific criteria that will be used to decide who will be EXCLUDED from the research. Define 
technical terms in lay language, as applicable.  
 
Already having a sibling enrolled in the study, having any food allergy or dietary restriction associated 
with produce products, not being able to receive text messages, and not meeting the minimum age or 
exceeding the maximum age as stated above.  
 
 
14 Total Sample Size 
Enter the total target sample size below.  
 
 
We will invite all families across all 11 participating sites. Given numbers from the current year, we 
expect total number that could be invited (meeting inclusion/ exclusion criteria) to be 350 total index 
parent and child pairings. Below we discuss various realistic recruitment and retention scenarios given 
the capacity of our partner, BGCAA. Our aim will be to maximize recruitment but are prepared for 
various recruitment scenarios. 
15 
Sample size rationale 
Describe your sample size rational below.  
 
 
 
We are conducting both as-treated (AT) and intention-to-treat (ITT) analyses.    
 
To inform our sample size calculations and power for the ITT and AT analyses, we relied on 
information from the pilot trial conducted at BGCAA sites in the spring of 2021.  The pilot also used 
the SPAN tool to measure diet for child and caregiver (Kahlon et al., 2022).  
 
For the AT analysis, we use the results of the pilot from Spring of 2021 showing a dose response 
correlation, which was r = 0.31.  We have 80% power to detect this association with total N = 79. Even 
if the enrollment and retention is as low as n= 64 for each active arm, we would be able to detect a 
dose-response correlation as low as 0.24 in the AT framework. 
 
From the 2021 study, the effect size for the overall child’s HEI (Healthy Eating Index) at the end of the 
study was .47 with an ICC of .20 for person x site clusters. For the present study, to be able to detect 
an identical difference between the two randomized arms (Program+Family Support and After-school 
program only) with 80% power at alpha = .05, we would need to retain 120 children in each arm. 
Considering a 15% attrition rate, a target recruitment of approx. 140 children into each active arm 
would permit sufficient power to observe the targeted moderate group difference.  
 
 Given the recruitment pool for our sample is limited by the BGCAA program capacity, we estimated 
the changes in effect sizes (i.e., our ability to detect differences) in two scenarios, maintaining 80% 
power at alpha = .05. 
 

Page 18 of 37 
 
SCREENING AND RECRUITMENT 
 
17 
Identification and/or Screening Procedures 
Describe the identification and/or screening procedures below. 
 
 
The Identification of interested families will be done both by the BGCAA staff and our study staff 
through the various places where BGCAA can be reached, as follows:   
 
• Distribution of flyers containing a QR code that links to an interest form to request more 
information later – at BGCAA sites & digitally via Class Dojo app that BGCAA staff use to 
communicate with families. In this form, if collecting interest information, we will collect the 
parent/guardian name, child name, school and/or afterschool site they attend, contact phone 
number, grade child will be in the fall, and preferred language. The path the QR code takes 
Assuming that all eligible households will be invited to participate and that a conservative potential 
pool of approx. 300 households will be maintained in the fall (in the current school semester, Boys 
and Girls Club has approximately 313 households attending their after-school program with at least 
one child), we can expect the following: 
• If we successfully enroll 75% in the study, N=226 
o With n=113 households in each active arm, we can detect a moderate effect size d= .45. 
o Considering 15% attrition in each arm, we would end the study with n=96 in each active 
arm and able to detect an effect size of d= .49. 
• If we successfully enroll 50%, N=150  
o With n=75 in each active arm, we can detect a difference of moderate effect size d=.55 
o Considering 15% attrition, n=64 in each arm enable us to detect an effect size of d= .60. 
 
Therefore, we will invite to participate in the study all households with at least one eligible child to 
maximize our ability to detect meaningful mean differences in children’s HEI between the two active 
arms.  
  
16 
Identification and Screening 
 
Check the box below if this study involves a screening process prior to the informed consent process.   
 
 
☒ This study involves obtaining information or biospecimens for the purpose of 
screening, recruiting or determining eligibility of prospective subjects prior to 
informed consent by either: 
1. Oral or written communication with the prospective subject or LAR 
2. By accessing records containing identifiable private information or stored 
identifiable biospecimens. 

Page 19 of 37 
 
them will be to a secure and HIPAA-compliant database (UT Box, REDCap, and/or UT Qualtrics) 
that will securely house the information to be filled out by the parent/guardian.   
• Tabling at participating BGCAA sites during parent pick-up (after the after-school program) 
and/or events by our study staff. If a parent wants to sign up to be contacted to learn more, 
the same fields listed above in bullet 1 will be captured by study staff to contact them at a 
later time. This data will be collected in the same way as mentioned in bullet 1 and also stored 
in the same way. BGCAA staff will not actively recruit participants on their own and will refer 
all questions about the study to the research study staff members.  
• Posting about the research study on ClassDojo, a virtual platform BGCAA uses to communicate 
with their members. We also plan to use a QR code for the parents to learn more about the 
program (link to recruitment flyer) through BGCAA normal practices of communicating 
information to their members. 
• BGCAA will share the families participating in the after-school program at the beginning of the 
2023-2024 school year, so Factor Health research staff will know which families to reach out in 
regards to the program. Similarly, BGCAA will let Factor Health research staff know the 
families that are on the waitlist as of the beginning of the 2023-2024 school year. 
• Tabling at participating BGCAA sites during parent pick-up (after the after-school program) 
and/or events both by our study staff and/or BGCAA site staff.  
• Building upon BGCAA’s regular process of notifying caregivers’ child of enrollment into the 
after-school programming. 
• Interested families will be further screened at BCGAA sites or via phone call by having the 
“Intro Script” (uploaded as part of the local site documents) read to them.  
The families that express interest in joining the study or learning more about it will have their contact 
information (as above) added to a spreadsheet (i.e. interest list) kept securely in UT Box. Research 
staff from Dell Medical School involved in the study will further screen for interest and eligibility via a 
phone call and/or text message. During this phone call, research staff will explain the study in more detail, 
including exclusion/inclusion criteria information. As part of the screening, the research staff member will ask if 
there are any food allergies or sensitivities to be aware of. If so, they will not be able to participate in the study.  
 
 
18 
Recruitment Overview 
 
Check box indicating all recruitment methods utilized for this research. 
 
 
☐ 
E-mail 
☒ Flyer 
 
☒ 
In-Person 
☐ Letter 
 
☐ 
Social Media 
☐ Research Pool 
 
☒ 
Telephone/Text 
☐ Snowball Sampling 
 
☐ 
Web-post 
☒ Word of Mouth 

Page 20 of 37 
 
19 
Describe the recruitment process, including where recruitment will take 
place. 
Describe recruitment procedures in the box below. Describe all elements checked above to provide a complete 
understanding of the recruitment strategies/methods.  
NOTE: Upload copies of all recruitment materials to UTRMS-IRB in the “Recruitment Materials” section.      
 
 
Recruitment:  
• Interest list  
• BGCAA staff and Factor Health research staff (research associates, RAs) will use various 
methods (described in section 17) to identify interested participants. The name and 
contact of these potential participants will be put on a spreadsheet in UT Box and this will 
serve as the interest list that study members will use to recruit people into the program. 
The spreadsheet will only be shared between BGCAA staff and Factor Health research 
staff.  
• RAs will outreach to the individuals on the interest list and explain the study in more detail 
before following consent/assent procedures. 
• Tabling activities:  
o Research Staff will table at BGCAA sites when parents are expected to be there (i.e. 
pick-up/drop-off after school, etc.). From these tabling activities, staff can hand out 
flyers and inform potential participating families about the study. RAs will collect 
contact names and phone numbers (specific fields indicated in Section 17) and will add 
to the interest list.  
 
 
 
 
OBTAINING INFORMED CONSENT 
 
20 
Consent Overview 
 
Check the box(es) for consenting procedures that will be used.  
 
 
☐ 
Obtaining Written Informed 
Consent/Parental Permission 
☒ Requesting a Waiver of Documentation of 
Informed Consent 
 
☐ 
Requesting a Waiver of 
Informed Consent 
☐ Requesting an Alteration of the Required 
Elements of Informed Consent 
 
☒ 
Obtaining Child Assent 
☐ Obtain Consent Using a Short Form with a 
Witness 

Page 21 of 37 
 
 
21 
Consent and Assent Processes 
 
Provide a detailed description of consent/assent procedures in the box below. Include: who will obtain consent, 
where will consent be obtained, how is consent obtained, how consent/assent is documented, and when the 
consent process will occur in such a manner that participants will have sufficient time for adequate 
consideration.   
NOTE: Upload copies of all consent/assent/permission forms/scripts to UTRMS-IRB in the “Consent Forms” 
section. This is required for UTRMS-IRB to appropriately stamp consent forms for approval.  
 
 
1. Research team members will contact by phone and/or text the individuals who indicated 
interest in the study via recruitment strategies and will further explain the study to confirm 
interest and screen participants.  
2. When interest is confirmed, the research team member will ask individual for their e-mail and 
e-mail copies of the consent and assent forms. Then the research staff will proceed to read 
through the consent and assent forms over the phone (if the potential participant is willing to 
provide us an email address to do so). They will allow as much time as the person needs to ask 
any questions they may have.  
3. Research staff will also explain that the research is voluntary and they are not required to 
participate and may withdraw at any time for any reason. If the potential participant agrees to 
participate, they will be asked for their verbal consent and parental permission. Attainment of 
verbal consent and parental permission will be documented in Redcap. Verbal consent and 
parental permission will be obtained to reduce burden on participating families.  
4. After parent/guardian has given their consent, researcher will talk with child and read through 
the assent form over the phone. Similarly, they will allow time to answer questions and 
explain that the research is voluntary. Once the child agrees to participate, the verbal assent 
will be documented in Redcap.  
 
E-mail addresses will only be used to send consent and assent forms. No other correspondence will 
take place via e-mail.  
 
When more than one child could be eligible for the study, the parent will be asked to select the child 
to be enrolled and assented into the study. 
 
Copies of blank consent forms can be provided to families at BGCAA events, if potential participants 
wish to have a copy prior to expressing full interest. 
 
For Spanish speaking families, consent will be provided in Spanish. The Spanish-translated consent 
forms will be uploaded to UTRMS via modification prior to administration.  
 
 
22 
Electronic Consent  
 
Check the box below if this study involves obtaining consent with an electronic signature. Be sure the section 
above is consistent.  
NOTE: This box should NOT be checked participants are responding “yes” or clicking “I Agree” on a consent 
form. This section should only be completed if an electronic signature is being obtained.  
 

Page 22 of 37 
 
 
 
 
☐ 
This study involves documenting informed consent/parental permission using 
an electronic signature.  
 
 
 
If true, specify method for obtaining e-consent below (e.g., DocuSign): 
 
 
 
      
 
23 
Consent and Translation 
Check the box below to indicate that consent documents/scripts will be translated to a language other than 
English.  
 
 
 
☒ 
The study population will likely include participants whose limited English 
speaking status requires translation of the consent form. 
 
 
 
Translation Process 
If above is checked, complete the below information describing the translation process. Either A or B 
must be checked. 
 
 
A 
☐ 
The consent documents will be translated by a certified translator. 
 
 
B 
☒ 
A non-certified translator will translate the consent documents. 
If selected, complete the next two items below. Section describing qualifications must be 
completed and backtranslation (ii) must be true.  
 
 
i 
Describe the translator’s qualifications 
To input text, click in the light grey area below. 
 
 
 
Multiple English fluent and native Spanish speakers within research personnel. One will 
translate and the other will confirm translation. 
 
 
 
 
 
ii 
☒ 
Another individual will confirm that the translation is accurate and 
appropriate  
 
26 
Waiver of Documentation of Informed Consent  
 
Only complete this section if a waiver of documentation of consent is requested (checked above in #21). To 
approve a waiver of documentation of consent, one of the following options must be appropriate and justified 
by the researcher.  
Please choose one waiver option and provide additional information as prompted.  Waiver option 2 is most 
common.  
 

Page 23 of 37 
 
 
A Waiver Option 1 
 
 
Check the box below for each item (all required – #1-4) and provide protocol-specific information as to 
how the criteria below are met.    
NOTE: This is the only applicable waiver of documentation option for greater than minimal risk 
research. If your study is greater than minimal risk and does not meet Option 1 criteria, you will need 
to obtain written consent.   
1 ☐ 
 
The only record linking the subject and the research would be the consent 
document. 
 i Provide protocol specific information as to how this criterion is met. 
To input text, click in the light grey area below 
 
 
     
 
 
2 ☐ 
 
The principal risk would be potential harm resulting from a breach of 
confidentiality. 
 i Provide protocol specific information as to how this criterion is met. 
To input text, click in the light grey area below 
 
 
     
 
 
3 ☐ 
 
Each subject will be asked whether the subject wants documentation 
linking the subject with the research, and the subject’s wishes will govern. 
 i Provide protocol specific information as to how this criterion is met. 
To input text, click in the light grey area below 
 
 
     
 
 
4 ☐ Describe the mechanism for documenting that informed consent was 
obtained 
  
Briefly explain how the researcher will document that consent was obtained from participants.  
  
     
 
 
 
B Waiver Option 2 

Page 24 of 37 
 
 
Check the box below for each item (all required – 1-3) and provide protocol-specific information as to 
how the criteria below are met.    
1 ☒ 
 
The study is minimal risk. 
 i Provide protocol specific information as to how this criterion is met. 
To input text, click in the light grey area below 
 
 
Surveys can be collected over the phone and minimize burden on participants. Though 
we will collect in-person height and weight measurements on the child, these will be 
done at events that parents don’t typically attend. In addition, we aim to collect 
survey measurements before the in-person measurements, due to the program 
schedule. 
 
 
2 ☒ 
 
Written consent would not be required outside the research context. 
 i Provide protocol specific information as to how this criterion is met. 
To input text, click in the light grey area below 
 
 Families already participate in BGCAA programs outside the research context, which does 
not require written consent.  
 
 
3 ☒ Describe the mechanism for documenting that informed consent was 
obtained 
  
Briefly explain how the researcher will document that consent was obtained from participants. To 
input text, click in the light grey area below. 
 i Informed consent and assent will be tracked in REDCap along with the 
enrollment/baseline measurement data.  
  
 
C Waiver Option 3 
 
Check the box below for each item (all required – 1-4) and provide protocol-specific information as to 
how the criteria below are met.    
1 ☐ 
 
The subjects or legally authorized representatives are members of a distinct 
cultural group or community in which signing forms is not the norm 
 
i 
Describe the cultural group or community. 
 
 
      
 

Page 25 of 37 
 
 
 
 
 
2 ☐ 
 
The research presents no more than minimal risk of harm to subjects. 
 i Provide protocol specific information as to how this criterion is met. 
To input text, click in the light grey area below 
 
 
     
 
 
3 ☐ 
 
There is an appropriate alternative mechanism for documenting that 
informed consent was obtained. 
 i Provide protocol specific information as to how this criterion is met. 
To input text, click in the light grey area below 
 
 
     
 
 
4 Describe mechanism for documenting that informed consent was obtained 
To input text, click in the light grey area below 
       
 
27 
Waiver or Alteration of Informed Consent  
 
Only complete this section if a waiver or alteration of consent is requested. To approve a waiver or alteration 
of consent, all of the following criteria must be appropriate and justified by the researcher. All boxes must be 
checked.  
SKIP THIS SECTION IF NOT REQUESTING A WAIVER/ALTERATION OF CONSENT 
 
 
A 
☐ 
 
The research involves no more than minimal risk to the subjects.  
 
 
i 
Provide protocol specific information as to how this criterion is met.  
 
 
 
To input text, click in the light grey area below 
 
 
 
      
 
 
 
 
 
 
B 
☐ 
 
The waiver or alteration will not adversely affect the rights and welfare of 
the subjects.  

Page 26 of 37 
 
 
 
 
 
i 
Provide protocol specific information as to how this criterion is met.  
 
 
 
To input text, click in the light grey area below. 
 
 
 
      
 
 
 
 
 
 
C 
☐ 
 
The research could not practicably be carried out without the waiver or 
alteration (it is impracticable to perform the research if obtaining consent 
is required and not just impracticable to obtain consent).  
 
 
 
i 
Provide protocol specific information as to how this criterion is met.  
 
 
 
To input text, click in the light grey area below. 
 
 
 
      
 
 
 
 
 
 
D 
☐ 
 
If the research involves using identifiable private information or 
identifiable biospecimens, the research could not practicably be carried 
out without using such information or biospecimens in an identifiable 
format.  
 
 
 
i 
Provide protocol specific information as to how this criterion is met.  
 
 
 
To input text, click in the light grey area below. 
 
 
 
      
 
28 Deception/Incomplete Disclosure and Debriefing 
Only complete the sections below if requesting an alteration of informed consent for research that involves 
deception/incomplete disclosure.  
Deception (as applies to research) means intentionally giving research subjects false information in order to 
establish false beliefs during the course of a research study. 
Incomplete disclosure means that the principal investigator withholds some information about the real purpose of 
the study or the nature of the research procedures. 
See IRB Policies and Procedures Section 15 for a description of deception. 
If this study does not involve deception/incomplete disclosure, skip this section. 
 
A 
☐ It is appropriate to provide additional pertinent information to the subject 
after research activities are complete (e.g., the researcher needed to deceive 
the subject to the nature of the study). 
 
B 
☐ Research participants will have the opportunity to withdrawal their data 
during the debriefing. 

Page 27 of 37 
 
BENEFITS 
29 
Benefits to Society 
Describe the scientific and societal benefit(s) below. 
 
 
Addressing nutrition through delivery of produce boxes and grocery store gift cards could potentially 
result in families with elementary school aged children not only obtaining the opportunity to try more 
fruits and vegetables, but improve their overall diet.  
 
 
30 
Potential Direct Benefits to Participants 
Click on the applicable check box. A or B must be checked.  
 
 
A 
☐ 
There is no anticipated direct benefit to participants. 
 
 
B 
☒ 
There are anticipated benefits to participants. 
 
 
 
i 
If applicable, describe the potential direct benefits to participants. 
 
 
 
Describe potential direct benefits to participants below.  
 
 
C 
Describe the nature of deception/incomplete disclosure and why it is necessary 
to conduct the research. 
To input text, click in the light grey area below. 
 
 
      
 
 
 
 
 
D 
Describe debriefing procedures. 
To input text, click in the light grey area below. NOTE: Upload the debriefing form to UTRMS-IRB in the 
“Consent Forms” section.  
 
 
      
 
 
 
 
Participating families may or may not benefit from this study. Families participating in 
this study may see the anticipated direct benefit of improved diet and access to healthy 
foods.  

Page 28 of 37 
 
RISKS 
31 
Describe the risks associated with each activity in this research 
To input text, click in the light grey area below. Note: Risks should also be outlined in the consent form(s).  
 
 
• Accidental loss of confidentiality 
• Although the study team and our BGCAA partners are taking every effort to minimize the 
possibility, psychological distress related to in-person weight measurement could occur.  
• Potential discomfort answering the research questions about diet and exercise habits, and 
other personal details about their lives and health.  
• May discover new food allergies or sensitivities from trying new foods (intervention arm 
ONLY, control does NOT get food of any kind from us as part of the study).  
 
 
 
32 
Describe how each risk is mitigated/minimized. 
To input text, click in the light grey area below. Note: Risks mitigation should be outlined in the consent form(s), 
as applicable.  
 
 
• Participant study numbers within REDCap will be used to protect patient confidentiality.  All 
data will be stored in either Box or REDCap.  
• The height and weight measurements will be integrated within an activity at the health fair to 
minimize psychological distress related to these. 
• The research staff does not have control of the contents in the produce boxes, and we will not 
be able to accommodate special diets or prevent potential allergens from being in a produce 
box. As such, having a food allergy related to any produce product will result in exclusion from 
the program.  
• Resources will be provided to help families identify the signs of a food allergy or sensitivity 
(Intervention only). These resources will provide guidance on symptoms and what to do if 
symptoms appear, and will be given to intervention participants along with the recipes they 
receive with their produce boxes. 
 
 
 
33 
Data Safety Monitoring 
For additional information regarding data safety monitoring boards and data safety monitoring plans, please 
see Section 21 of our Policies and Procedures. 
One of the following must be checked (A, B, or C).  
 
 
A 
☒ 
 
In the investigator’s opinion, this study is minimal risk and does not 
require a Data Safety Monitoring Plan (DSMP) or a Data Safety 
Monitoring Board (DMSB). 
PLEASE NOTE: The IRB may determine minimal risk studies do require data safety monitoring 
under certain circumstances (e.g., if there is a known risk with an expected frequency).  
 

Page 29 of 37 
 
 
B 
☐ 
 
This study does not have a Data Safety Monitoring Board, but 
researchers have an internal plan to monitor for safety (Data Safety 
Monitoring Plan (DSMP)). 
Complete Data Safety Monitoring Details  
 
 
C 
☐ 
 
This study has a Data Safety Monitoring Board (DSMB). 
Complete Data Safety Monitoring Details section below or upload this study’s Data Safety 
Monitoring Board’s charter that contains the information below.  
 
 
34 
Data Safety Monitoring (Details) 
Complete this section if the study has a Data Safety Monitoring Plan. SKIP this section there is not a 
DSMP/DSMB. 
If the study has a DSMB, ensure all items below are addressed in the charter (and charted uploaded to UTRMS-
IRB) or provide additional information below, as needed.  
 
 
A 
How is safety information collected? 
To input text, click in the light grey area below. 
 
 
 
      
 
 
 
 
 
B 
When will safety data collection start (for each participant or for the whole 
study, as applicable)? 
To input text, click in the light grey area below. 
 
 
 
      
 
 
 
 
 
C 
How frequently will safety data be collected? 
To input text, click in the light grey area below. 
 
 
 
      
 
 
 
 
 
D 
Who will review the data for safety? 
To input text, click in the light grey area below. 
 
 
 
      
 
 
 
 
 
E 
How frequently will data be monitored for safety concerns? 
To input text, click in the light grey area below. 

Page 30 of 37 
 
 
 
 
      
 
 
 
 
 
F 
What data will be reviewed? 
To input text, click in the light grey area below. 
 
 
 
      
 
 
 
 
 
G 
State the frequency or periodicity of the review of cumulative data. 
To input text, click in the light grey area below. 
 
 
 
      
 
 
 
 
 
H 
State any conditions that would trigger an immediate suspension of the 
research. 
To input text, click in the light grey area below. 
 
 
 
      
 
 
35 
Early Withdrawal 
Only complete this section if there are planned conditions under which a participant will be withdrawn from 
the study. If not applicable, skip to next section. Include this information in your consent form. 
 
 
A 
List the criteria for withdrawing individual participants from the study (e.g., 
safety or toxicity concerns, emotional distress, inability to comply with the 
protocol, or requirements from study sponsor). 
To input text, click in the light grey area below. 
 
 
 
Participants may be withdrawn if it is determined it is unsafe for them to continue with the 
program. They may also be removed if a child leaves the BGCAA program and is in one of the 
randomized arms. 
 
 
 
 
 
B 
Describe any necessary procedures for ensuring the safety of a participant 
who has withdrawn early. 
To input text, click in the light grey area below. 
 
 
 
There are no procedures in place to ensure the safety of a participant that is withdrawn 
early.  This is a minimal risk study and being withdrawn poses no risk to the participant.  

Page 31 of 37 
 
 
 
 
36 
Describe any pre-specified criteria for stopping or changing the study protocol due 
to safety concerns. 
To input text, click in the light grey area below. 
 
 
None.  
 
REQUIRED DISCLOSURES 
 
37 
Required Consent Disclosures  
Identify each element below that may require additional information to be disclosed in the consent form. 
Click on the check box (or double click and type an “X” if using Google Docs).  
 
 
A 
☒ It is reasonable that researchers could discover or suspect child or elder abuse. 
Add appropriate disclosure in consent form(s). 
 
B 
☐ It is reasonable that researchers could learn of an incident that could require 
reporting under Title IX. 
Add appropriate disclosure in consent form(s). See Title IX and Research Guidance for information and 
download the Title IX Reporting Form on the Special Topics page.  
 
C 
☐ It is reasonable that researchers could discover incidental findings or other 
information of medical interest about a participant's previously unknown 
condition. 
Add appropriate language to consent form(s).  
 
i 
Articulate methods for addressing and reporting incidental findings, if 
applicable. 
Ensure appropriate information is in consent form(s), as applicable.  
 
 
Given the population of interest involves children, it is reasonable that researchers could 
discover or suspect child abuse. If we learn during the study about child abuse or neglect, 
we will report the information to the appropriate authorities, including the police, Child 
Protective Services, and the Texas Department of Family and Protective Services.  
 

Page 32 of 37 
 
PRIVACY AND CONFIDENTIALITY 
 
38 
Privacy 
Describe how you will protect the identity and privacy of study participants during each phase of research. 
Privacy focuses on the individual participants rather than data. In this section, researchers should focus on 
issues such as where research activities take place and how participant involvement is protected from non-
participants. Describe methods to ensure participants’ privacy during identification, recruitment, screening, the 
consent process, the conduct of the study, and dissemination of data. 
To input text, click in the light grey area below. 
 
Participant privacy will be maintained by conducting data collection over the phone. RAs will ensure 
no one who is not involved in the study is listening or around them. All phone calls will be conducted 
using a phone number provided by the participant. Privacy for the height and weight measurement 
will be ensured by masking the height and weight measurements during a field day at BGCAA which is 
a normal activity they typically have. Everyone, regardless of their participation in this study will 
participate in these field day activities that recreational activities such as soccer, football, and 
basketball. To ensure privacy of non-participants, both research participants and non-participants will 
have their height and weight taken at the field day, but only the data of the research participants will 
be collected. All data to be collected by study staff will be done so discreetly on a secure file and in a 
secure database.  
39 
Confidentiality and Data Security Plan 
Provide general information below regarding confidentiality and data security plan. Provide additional details 
regarding how you will protect the confidentiality of data or address confidentiality concerns.  
Include the following, as applicable:  
• 
If identifiers will be coded to protect confidentiality describe how and where identifiers are stored.  
• 
Describe where and how data is stored and maintained. 
• 
Include details regarding storage of consent forms, if applicable. 
To input text, click in the light grey area below. 
 
All data will be stored in the Dell Medical School REDCap database and/or on UT Box. These secure, 
HIPAA compliant databases can only be accessed with password and dual authentication. REDCap will 
assign participants a unique study ID, protecting confidentiality.  
 
Because verbal consent and assent will be obtained, no consent forms will need to be stored.  
 
 
40 
Research Data/Records Destruction Details  
 
Confirm general research data/information (including consent forms, as applicable) destruction timeline. One of 
the following must be checked.  
 
☒ 
Research Data/Records will be retained for 3 years after study completion per 
UT record retention policy.  
 

Page 33 of 37 
 
 
42 Data Access 
 
Click on the check box (or double click and type an “X” if using Google Docs) for each group of individuals that 
will have access to study data. 
If you plan on creating a repository, complete the repository form as well (download from Library in UTRMS-
IRB). 
 
 
☒ Study Team 
Members 
☒ External Collaborators 
☐ Data coordinating center 
 
☐ Sponsor 
☒ Future Sharing with 
other researchers 
 
☐ Others 
Describe below. To input text, click in the light grey area below. 
 
 
     
 
 
☐ 
Research Data/Records will be retained for longer than 3 years and retention 
information is provided below.  
Describe data retention timeline below. To input text, click in the light grey area below. 
 
 
      
 
 
 
41 
Confirm identifiable data destruction details 
One of the following must be checked.  
 
☒ 
Identifiable data will be destroyed.  
If checked, ensure the below section describes identifiable data destruction plan and timeline.   
 
 
Identifiers will be destroyed 3 years after the completion of the study after all data has been 
analyzed. After the study ends, The University of Texas at Austin might contact participants to 
determine interest in media opportunities, which would be completely optional for them to 
partake in.  
 
 
 
☐ 
Identifiable data will not be destroyed.  
If checked, explain below the rationale for retaining identifiable data indefinitely.  
 
 
      
 

Page 34 of 37 
 
 
COMPENSATION AND COSTS 
43 
Describe data sharing plan for each group checked above and state whether 
researchers plan on sharing identifiable, coded, or de-identified data. 
To input text, click in the light grey area below. Ensure that data sharing and future use is addressed in the 
consent form(s).  
 
Due to the nature of the study, identifiable data will be shared with BGCAA during the study. This is 
necessary to be able to conduct the research study as BGCAA needs to know which of their members 
are receiving the intervention. We will not record data of ineligible participants. Non-aggregated and 
de-identified study data may be shared with BGCAA after analysis for the purpose of improving 
programming within their organization. Aggregated and de-identified data will be shared with BGCAA 
and may be presented in public forums.  
 
We may share data with other researchers for future research studies that may be similar to this 
study or may be different. The data shared with other researchers will not include information that 
can directly identify the participant.  
 
44 
Certificate of Confidentiality  
Click on the check box (or double click and type an “X” if using Google Docs) to identify each element below that 
may require additional information to be disclosed in the consent form. 
If a Certificate of Confidentiality is not applicable for this study, skip this section.  
 
 
A 
☐ 
 
NIH has issued a Certificate of Confidentiality for this study. 
Ensure CoC language is included in the consent form(s).  
 
B 
☐ 
 
A Certificate of Confidentiality has not been obtained, but there are plans to 
apply for one. 
Ensure appropriate CoC language is included in consent form(s). Apply for a CoC for non-NIH funded 
research here: NIH Certificate of Confidentiality System. Once CoC is granted by NIH, you must update 
the consent form language and ensure a copy of the CoC approval (only for non-NIH funded research) 
is uploaded to UTRMS-IRB.  
45 
Compensation  
Click on the check box (or double click and type an “X” if using Google Docs). A or B must be checked.  
 
 
A 
☒ 
 
Subjects receive compensation. 
 
 

Page 35 of 37 
 
 
 
i ☒ Confirm: Amount of compensation and its form is reasonable for this 
population for the activities requested of them. 
 
 
 
 
ii Total Amount of Compensation  
Include the total amount of compensation below.  
 
 All participating families, whether in the intervention or control arm will be paid $30 for each 
measurement (baseline, mid-point and follow-up), for a total of up to $90.  
 
 
 
iii Type of Compensation  
 
 
☐ Cash  
☐ 
 
Check  
☒ 
 
Gift Card 
 
 
☐ Course Credit 
☐ ClinCard 
☒ Tango Card 
 
 
☐ Other 
 
 
 
Describe other form of compensation below.  
 
 
      
 
 
 
 
 
iv Proration Schedule  
Describe the proration schedule for multi-visit/session studies. Skip if not applicable.  
 
 
Participating families will be paid $30 for each measurement (baseline, mid-point, and follow-
up) for a maximum of $90 over the duration of the study. Gift cards will be distributed to the 
participants via text message at the end of each measurement.  
 
 
 
B 
☐ 
 
Subjects will not receive compensation. 
46 
Costs 
A or B must be checked.  
 
 
 
A 
☒ 
Participants will have no costs associated with this study 
 
B 
☐ 
Participants will have the following costs associated with this study.  

Page 36 of 37 
 
 
 
CONFLICTS OF INTEREST 
This section is required for all studies. Please confirm that all research personnel who meet the definition of “covered 
individuals” are designated as such in the Local Study Team Members section of the SmartForm application in UTRMS-
IRB.  
 
 
 
☐Standard of care procedures 
contributing to study data 
 
☐ Research procedures not 
associated with standard of 
care 
 
 
 
☐Administration of drugs / devices  
☐ Study drugs or devices 
 
 
 
☐Transportation and parking  
i 
Describe all costs below. 
To input text, click in the light grey area below. 
 
 
 
 
 
 
 
      
 
47 
Financial Conflicts of Interest 
Financial interest includes utilizing your licensed intellectual property in the study; serving as a paid consultant, or 
advisory board member, or officer/director with a related entity; and equity or business ownership in a company 
that is related to this project.  Additional guidance on financial conflicts of interest is available on the COI website 
 
A or B must be checked.  
 
 
 
A 
☐ 
The PI and/or other covered individual(s) has/have a financial interest 
related to this study  
i 
If A is checked above, please provide the name(s) of the covered 
individuals involved, and briefly describe the interest: 
 
 
 
To input text, click in the light grey area below. 
 
 
 
      
 
 
B 
☒ 
To the best of your knowledge, no one on the study team has financial 
interest related to this study  
48 
Non-financial Conflicts of Interest 
Non-financial Interests could include such things as: 
- utilizing your unlicensed intellectual property in the study, 

Page 37 of 37 
 
 
- serving as an unpaid advisory board member or officer/director with a related entity,  
- equity or business ownership in a company that has yet to make a profit and is related to this project, 
- conflict of time/effort, 
- personal and professional relationships/affiliations, 
- intellectual passions or personal beliefs 
- other factors that could create bias in the study  
 
A or B must be checked.  
 
 
A 
☐ 
The PI and/or other covered individual(s) has/have a non-financial interest 
related to this study  
i 
If A is checked above, please provide the name(s) of the covered 
individuals involved, and briefly describe the interest: 
 
 
 
To input text, click in the light grey area below. 
 
 
 
      
 
 
B 
☒ 
To the best of your knowledge, no one on the study team has non-
financial interest related to this study