Lunchtime Meal Feeding Study for Preschool Children
Phase: NA
Conditions: Feeding Behavior
Sponsor: Penn State University

 
 
Variations in Palatability and Portion Size of Vegetables 
on Meal Intake of Preschool Children 
 
ClinicalTrials.gov Protocol ID: ChildFood402 
ClinicalTrials.gov ID Number: NCT03926065 
 
 
Principal Investigator: Dr. Barbara J. Rolls 
Sponsor: The Pennsylvania State University 
 
 
Grant Title: Strategies to Moderate Energy Intake  
for the Prevention of Obesity in Children 
Grant Number: R01DK082580 
Funded by: National Institute of Diabetes and Digestive 
and Kidney Diseases 
 
 
Institutional Review Board 
The Pennsylvania State University 
IRB ID: STUDY00012358 
Initial Approval Date: 10 May 2019 
IRB Protocol Document version 0.03 
Approval Date: 26 February 2020 
 
 
 
 

Table of Contents 
 
  1.0 Objectives 
  1 
  2.0 Background 
  2 
  3.0 Inclusion and Exclusion Criteria 
  2 
  4.0 Recruitment Methods 
  3 
  5.0 Consent Process and Documentation 
  4 
  6.0 Study Design and Procedures 
  5 
  7.0 Subject Numbers and Statistical Plan 
  8 
  8.0 Data and Safety Monitoring Plan 
  9 
  9.0 Risks  
 10 
10.0 Potential Benefits to Subjects and Others 
 10 
11.0 Sharing Results with Subjects 
 11 
12.0 Subject Payment and/or Travel Reimbursements 
 11 
13.0 Economic Burden to Subjects 
 11 
14.0 Other Approvals 
 11 
15.0 Adverse Event Reporting 
 11 
16.0 Study Monitoring, Auditing, and Inspecting 
 12 
17.0 Future Undetermined Research: Data and Specimen Banking 
 12 
18.0 References 
 13 
19.0 Confidentiality, Privacy, and Data Management 
 13 
 
 

1 
 
 
1.0 
Objectives 
 
1.1 
Study Objectives 
 
Aim: To determine the effects of varying both the palatability and portion size of 
vegetables served to preschool children at a meal on the outcomes of vegetable 
intake, food intake, energy intake, and energy density at the meal. 
 
Hypotheses: 
 
1. For the outcome of vegetable intake at the meal: 
a. Enhancing the palatability of vegetables served at the meal will increase 
vegetable intake. 
b. Increasing the portion size of vegetables served at the meal will increase 
vegetable intake. 
c. Enhancing the palatability of vegetables served at the meal will interact 
with vegetable portion size to increase its effect on vegetable intake. 
 
2. For the outcome of food intake at the meal: 
a. Enhancing the palatability of vegetables served at the meal will increase 
food intake. 
b. Increasing the portion size of vegetables served at the meal will increase 
food intake. 
 
3. For the outcome of energy intake at the meal: 
a. Enhancing the palatability of vegetables served at the meal will increase 
energy intake. 
b. Increasing the portion size of vegetables served at the meal will increase 
energy intake. 
c. Enhancing the palatability of vegetables served at the meal will interact 
with vegetable portion size to increase its effect on energy intake. 
 
4. For the outcome of food energy density at the meal: 
a. Enhancing the palatability of vegetables served at the meal will increase 
energy density. 
b. Increasing the portion size of vegetables served at the meal will decrease 
energy density. 
 
1.2 
Primary Study Endpoints 
 
1. Weight (grams) of vegetables consumed at the meal 
 
1.3 
Secondary Study Endpoints 
 
1. Weight (grams) of food consumed at the meal 
2. Energy (kilocalories) consumed at the meal  
3. Energy density (kilocalories/gram) of food consumed at the meal  
 

2 
 
 
2.0 
Background  
 
2.1 
Scientific Background and Gaps 
 
The US Dietary Guidelines recommend that 3- to 5-year-old children consume at 
least one to two servings of vegetables each day (USDA, 2015). The majority of 
children, however, do not meet these recommendations (Ramsay et al., 2014). 
This finding has been attributed in part to children's low preference for vegetables 
compared to other foods (Ishdorj et al., 2015; Nicklaus et al., 2004). As a strategy 
to increase vegetable intake in children, a number of studies have tested serving 
larger portions of vegetables at a meal (Mathias et al., 2012; Spill et al., 2010; 
Kral et al., 2010). The results of these portion size studies, however, have been 
variable, which might be explained by differences in the palatability of the 
vegetables that were tested in the studies. It remains to be investigated whether 
increasing the palatability of vegetables compared to other meal components 
promotes vegetable intake when larger portions are served. Thus, this 
experiment aims to assess whether the palatability of vegetables influences 
vegetable intake in response to increases in vegetable portion size at a meal. 
 
2.2 
Previous Data 
 
In a previous study in preschool children (Matthias et al., 2012), the portion size 
of vegetable side dishes served at a meal was doubled, and it was found that this 
led to an overall increase in vegetable intake. However, a significant increase 
was only observed in the children who reported liking the vegetables (57% of 
children). These findings show that increasing the portion size of vegetables can 
lead to increases in intake in preschool children, but suggests that the effect 
depends on the palatability of the vegetables. 
 
2.3 
Study Rationale 
 
This study will increase understanding of the effects of vegetable palatability on 
children’s vegetable intake and will assess whether increases in palatability can 
be used in conjunction with increased portion size to promote vegetable intake in 
preschool children. 
 
3.0 
Inclusion and Exclusion Criteria 
 
3.1 
Inclusion Criteria 
 
1. Children who are between the ages of 3 and 5 years old and who are enrolled 
in a scheduled classroom of the childcare center. 
 
3.2 
Exclusion Criteria 
 
1. Children who are allergic to any of the foods served 
2. Children whose diets exclude any of the foods served 

3 
 
 
3. Children who will not be present at the childcare center for all of the scheduled 
study days (due to scheduled vacations, part-time enrollment at the childcare 
center, etc.). 
 
3.3 
Early Withdrawal of Subjects 
 
3.3.1 Criteria for removal from study 
 
Subjects will be removed from the study if they repeatedly fail to follow 
study protocol. 
 
All participation is voluntary. Children can refuse to participate in any 
session and parents, children, and teachers may withdraw from the study 
at any time. 
 
3.3.2 Follow-up for withdrawn subjects 
 
N/A 
 
4.0 
Recruitment Methods 
 
4.1 
Identification of subjects 
 
Children who are enrolled in the scheduled classroom at the childcare center, 
along with their parents or guardians, will be invited to participate. 
 
Teachers in the classrooms of participating children will be invited to participate. 
 
4.2 
Recruitment process 
 
4.2.1 How potential subjects will be recruited 
 
We will recruit using a parent letter placed in each child's mailbox at the 
childcare center. A trained staff member who is approved to do 
recruitment and consenting of subjects will be available in the center 
during child pick up or drop off to explain the study and answer any 
questions parents may have. 
 
Teachers in classrooms of participating children will be verbally invited to 
participate by study staff. 
 
4.2.2 Where potential subjects will be recruited 
 
At the childcare center. 
 
4.2.3 When potential subjects will be recruited 
 
We will work with local child care centers to identify times which we can 
come in to collect data. 2 – 4 weeks before data collection begins, we will 
recruit participants. 

4 
 
 
 
4.2.4 Describe the eligibility screening process and indicate whether the 
screening process will occur before or after obtaining informed 
consent  
 
Children with allergies to foods served, or whose diets exclude these 
foods, will not be eligible to participate in this study. Children with > 1 
previously planned absence during any of the study days will also be 
excluded from participation. 
 
A screening questionnaire regarding food allergies, dietary exclusions, 
food intolerances, and attendance during planned study days will be 
included with the consent form. 
5.0 
Consent Process and Documentation  
 
5.1 
Consent Process: 
Check all applicable boxes below: 
 
  Informed consent will be sought and documented with a written 
consent form [Complete Sections 5.2 and 5.6]  
 
  Implied or verbal consent will be obtained – subjects will not sign a 
consent form (waiver of written documentation of consent) [Complete 
Sections 5.2, 5.3 and 5.6]  
 
  Informed consent will be sought but some of the elements of informed 
consent will be omitted or altered (e.g., deception). [Complete section 
5.2, 5.4 and 5.6]  
 
  Informed consent will not be obtained – request to completely waive the 
informed consent requirement. [Complete Section 5.5] 
 
5.2 
Obtaining Informed Consent  
5.2.1 Timing and Location of Consent  
 
The consent form will be signed by the parent prior to their child’s 
enrollment in the study. Consent will be obtained at the childcare center 
with a trained member of the lab staff present.  
 
Teachers will consent (to fill out questionnaires about enrolled children) at 
the childcare center during the first study week in their classroom. 
5.2.2 Coercion or Undue Influence during Consent  
 
Parents will be given the consent form to take home to review on their 
own and can decide whether they want their child to participate. 
 

5 
 
 
Teachers will be given the opportunity to review the consent from on 
their own and can decide if they wish to participate. 
 
5.3 
Consent – Other Considerations  
 
5.3.1 Non-English-Speaking Subjects 
 
It is not anticipated that there will be any non-English speaking or illiterate 
parent participants. 
 
5.3.2 Cognitively Impaired Adults 
 
5.6.2.1 Capability of Providing Consent 
 
N/A 
 
5.6.2.2 Adults Unable to Consent 
 
N/A 
 
5.6.2.3 Assent of Adults Unable to Consent 
 
N/A 
 
5.3.3 Subjects who are not yet adults (infants, children, teenagers)  
 
5.6.3.1 Parental Permission 
 
Parents will sign consent for their child to participate. Two copies 
of the consent form will be provided, one to be signed and 
returned to study staff, and one to be kept for parents’ records. 
 
5.6.3.2 Assent of subjects who are not yet adults 
 
Children can refuse to eat any meal if they choose. Before 
beginning measurement of height and weight or the Tasting 
Game, children will be asked if they want to participate and can 
refuse to do so. 
 
6.0 
Study Design and Procedures 
 
 
6.1 
Study Design 
 
This study will have a within-subject design with four experimental conditions. 
Once a week for four weeks, children will be served a meal consisting of a main 
dish, fruit, vegetables, and milk. On different occasions, the vegetables served at 
the meal will be varied in both palatability and portion size. The palatability will be 
either standard (steamed, plain vegetables) or enhanced (vegetables with added 
flavoring) and the portion size will be either baseline (100%) or larger (200% of 
baseline). 

6 
 
 
The experimental conditions will be as follows: 
1. Standard palatability of vegetables and 100% portion size of vegetables 
2. Standard palatability of vegetables and 200% portion size of vegetables 
3. Enhanced palatability of vegetables and 100% portion size of vegetables 
4. Enhanced palatability of vegetables and 200% portion size of vegetables 
 
The order of presenting the conditions across study weeks will be 
counterbalanced by classroom. All meals will meet the minimum guidelines 
outlined by the USDA and Child and Adult Care Food Program 
(CACFP). 
 
6.2 
Study Procedures 
 
1. On one day a week for four weeks, enrolled children will be served a lunch of 
foods commonly served in the childcare center and following the regular meal 
schedule. Menus have been developed from the childcare center menus to be as 
similar as possible to the foods that children are served regularly. Milk will be 
served as beverage. Meals will be served at tables of 3 to 6 children and one 
adult, which is a standard practice at the childcare centers. The adults at the 
table will be instructed not to discuss the food or to encourage the children to eat. 
Each participant will be served an individual pre-weighed meal. All food and 
beverage items will be weighed with an electronic food scale before and after 
meals in order to determine the amount consumed. Participants will be told they 
can eat as much or as little of the foods as they would like. Trained research 
personnel will observe each mealtime and will document food and beverage 
spillage and any comments made about the food. 
 
2. After all study meals are completed, trained research personnel will return to 
the childcare center to measure the height and weight of enrolled children. Body 
weight will be measured in triplicate using a portable digital scale. Height will be 
measured in triplicate using a portable stadiometer. Enrolled children will also be 
invited to participate in the Tasting Game. They will be asked to taste a small 
amount of each food served in the study and indicate their liking of the food by 
pointing to one of three cartoon faces (Yummy, Just OK, and Yucky). Children 
will also be asked to rank their liking of each food in the meal and to indicate their 
preference for the vegetables with enhanced palatability compared to those with 
standard palatability.  
 
3. Parents will be asked to complete a demographic questionnaire, the Children 
and Adult Eating Behavior Questionnaire, the Vegetable Questionnaire, and a 
portion of the Child Feeding Questionnaire. These questionnaires (4 total) will 
assess whether certain child eating behaviors or parental feeding behaviors 
influence food intake. All will be administered and completed via paper and 
pencil. 
 
4. Photographs may be taken in the childcare center of children eating meals, 
participating in the Tasting Game, and having their height and weight measured. 
Taking such photographs will be subject to the consent provided by each parent 
concerning their child. 
 

7 
 
 
5. For each enrolled child, the classroom teacher who is most familiar with the 
child’s eating behavior will complete one questionnaire (Children’s Eating 
Behaviour Questionnaire). All will be administered and completed via paper and 
pencil. 
 
6.2.1 Visit 1   
 
Enrolled children will be served a lunch of foods commonly served in the 
childcare center and following the regular meal schedule. Milk will be 
served as beverage. Meal 1 will be served at tables of 3 to 6 children and 
one adult, which is a standard practice at the childcare centers.  
 
Each participant will be served an individual pre-weighed meal. All food 
and beverage items will be weighed with an electronic food scale before 
and after meals in order to determine the amount consumed. Participants 
will be told they can eat as much or as little of the foods as they would 
like. Trained research personnel will observe each mealtime and will 
document food and beverage spillage and any comments made about the 
food. 
 
6.2.2 Visit 2 (If applicable)  
 
Enrolled children will be served a lunch of foods commonly served in the 
childcare center and following the regular meal schedule. Milk will be 
served as beverage. Meal 2 will be served at tables of 3 to 6 children and 
one adult, which is a standard practice at the childcare centers.  
 
Each participant will be served an individual pre-weighed meal. All food 
and beverage items will be weighed with an electronic food scale before 
and after meals in order to determine the amount consumed. Participants 
will be told they can eat as much or as little of the foods as they would 
like. Trained research personnel will observe each mealtime and will 
document food and beverage spillage and any comments made about the 
food. 
 
6.2.3 Visit 3 (If applicable)  
 
Enrolled children will be served a lunch of foods commonly served in the 
childcare center and following the regular meal schedule. Milk will be 
served as beverage. Meal 3 will be served at tables of 3 to 6 children and 
one adult, which is a standard practice at the childcare centers.  
 
Each participant will be served an individual pre-weighed meal. All food 
and beverage items will be weighed with an electronic food scale before 
and after meals in order to determine the amount consumed. Participants 
will be told they can eat as much or as little of the foods as they would 
like. Trained research personnel will observe each mealtime and will 
document food and beverage spillage and any comments made about the 
food. 
 

8 
 
 
6.2.4 Visit 4 (If applicable)  
Enrolled children will be served a lunch of foods commonly served in the 
childcare center and following the regular meal schedule. Milk will be 
served as beverage. Meal 4 will be served at tables of 3 to 6 children and 
one adult, which is a standard practice at the childcare centers.  
 
Each participant will be served an individual pre-weighed meal. All food 
and beverage items will be weighed with an electronic food scale before 
and after meals in order to determine the amount consumed. Participants 
will be told they can eat as much or as little of the foods as they would 
like. Trained research personnel will observe each mealtime and will 
document food and beverage spillage and any comments made about the 
food. 
 
6.2.5 Visit 5 (If applicable) 
  
After all study meals are completed, trained research personnel will return 
to the childcare center to measure the height and weight of enrolled 
children. Body weight will be measured in triplicate using a portable digital 
scale. Height will be measured in triplicate using a portable stadiometer. 
Enrolled children will also be invited to participate in the Tasting Game. 
They will be asked to taste a small amount of each food served in the 
study and indicate their liking of the food by pointing to one of three 
cartoon faces (Yummy, Just OK, and Yucky). Children will also be asked 
to rank their liking of each food in the meal and to indicate their 
preference for the vegetables with enhanced palatability compared to 
those with standard palatability. 
 
6.3 
Duration of Participation 
 
Children’s study meals will be served during their usual meal time at the 
childcare center and will take no more than the usual time (30 minutes). The 
height and weight measurements and the Tasting Game on the final visit will 
require an additional hour of time. Completion of questionnaires will take 
approximately 30 minutes for parents and approximately 20 minutes per 
questionnaire for teachers. 
Total time commitment for parent and child should be no more than 3 hours. 
 
7.0 
Subject Numbers and Statistical Plan 
 
7.1 
Number of Subjects 
 
We estimated that we will need 49 children to complete the study in order to 
detect significant effects of vegetable palatability on vegetable intake. In order to 
allow for absences and withdrawal of participants, we will aim to enroll 65 
children. 
 
7.2 
Sample size determination 
 

9 
 
 
A power analysis was performed to determine the sample size needed to detect 
the effect on vegetable intake of enhancing the vegetables with small amounts of 
salt and butter; this effect was considered to be more difficult to detect than that 
of portion size. The variability in vegetable intake was estimated from a study in 
which toddlers were served vegetables with different amounts of butter and salt 
at different lunches (Bouhlal et al., 2011), as well as from our previous studies in 
3- to 5-year-old children (Smethers et al., 2019; Sanchez et al., 2019). The 
difference in vegetable intake to be detected was set at 10 g, which is about one-
third of the minimum vegetable serving size of the Child and Adult Care Food 
Program (CACFP) for lunch in this age group. In order to detect this difference in 
vegetable intake, the required sample size was estimated to be 49 children using 
a Type 1 error rate of 5% and a power of 80%. In order to allow for absences and 
withdrawals, we will aim to enroll at least 65 children in the study. 
 
7.3 
Statistical methods 
 
The primary outcome of this crossover study will be children’s vegetable intake 
by weight. Secondary outcomes will be meal food and milk intake, meal energy 
intake, and the energy density of the food consumed at the meal. Differences in 
mean outcomes across the two experimental factors will be analyzed using linear 
mixed models with repeated measures. The fixed factors in the model will be the 
experimental conditions of portion size (100% or 200%) and flavor (plain or 
enhanced), as well as study week, classroom, and sex of the child. The 
interaction between the factors of portion size and flavor will be tested for 
significance in all models and removed if not significant. Participants will be 
treated as a random effect. The Tukey-Kramer method will be used to adjust the 
significance level for multiple pairwise comparisons between means. Children 
who left <7 g of vegetables uneaten at ≥3 meals will be identified as “plate 
cleaners”, and vegetable intake will be analyzed both with and without these 
children. 
 
Analysis of covariance with linear mixed models will be used to assess the 
influence of continuous participant characteristics (age, body weight, height, BMI-
for-age percentile, BMI z-score, questionnaire subscales) on the relationship 
between experimental factors and vegetable intake. Categorical subject 
characteristics (sex, preference ratings for both versions of vegetables, and liking 
and ranking ratings of all meal components) will be tested as factors in the 
models. Ordinal logistic regression will be used to evaluate whether the 
distribution of the liking ratings of the vegetables differed significantly between 
the plain and enhanced versions; results will be reported as odds ratios with 95% 
confidence levels. Differences between boys and girls in age, body weight, 
height, BMI-for-age percentile, and BMI z-score will be evaluated by using t-tests. 
Outcomes from statistical models will be considered significant at p < 0.05. All 
data will be analyzed with SAS software (SAS 9.4, SAS Institute, Inc.). 
 
8.0 
Data and Safety Monitoring Plan 
 
8.1 
Periodic evaluation of data 
 
N/A 

10 
 
 
 
8.2 
Data that are reviewed 
 
N/A 
 
8.3 
Method of collection of safety information 
 
N/A 
 
8.4 
Frequency of data collection 
 
N/A 
 
8.5 
Individuals reviewing the data 
 
N/A 
 
8.6 
Frequency of review of cumulative data 
 
N/A 
 
8.7 
Statistical tests 
 
N/A 
 
8.8 
Suspension of research 
 
N/A 
 
9.0 
Risks 
 
There are minimal risks associated with participation in this study. The risks are no 
greater than those associated with the children’s usual attendance and consumption of 
meals at the childcare center, which include the risk of food allergy, food-borne illness, 
and choking on food. 
 
The amounts of food served in all experimental conditions meet or exceed minimum 
requirements for calorie and nutrient content for this age group as specified by the 
USDA and Child and Adult Care Food Program (CACFP). 
 
Teachers, children and parents risk loss of confidentiality. Measures will be taken to 
minimize this risk and include keeping all documents with personal information in a 
locked closet in the lab manager’s office. Only those listed on the IRB application will 
have access to those records.  
 
10.0 Potential Benefits to Subjects and Others  
 

11 
 
 
10.1 
Potential Benefits to Subjects 
 
None 
 
10.2 
Potential Benefits to Others 
 
The research will benefit society by advancing understanding of children’s eating 
behavior and identifying meal-related strategies for the prevention of obesity in 
children. 
 
11.0 Sharing Results with Subjects 
 
N/A 
 
12.0 Subject Payment and/or Travel Reimbursements  
 
Parents will be paid $20 upon completion of the study. Parents will receive an additional 
$40 for returning 4 questionnaires ($10 per questionnaire). If a participant does not, for 
any reason, complete all study meals, payment will be prorated at $5/meal. Total parent 
payment will be $60. 
 
Teachers will be paid $5 per questionnaire returned. 
 
13.0 Economic Burden to Subjects 
 
13.1 
Costs 
 
N/A 
 
14.0 Other Approvals 
 
14.1 
Other Approvals from External Entities 
 
The Bennett Family Center, Hort Woods Child Care Center at Hort Woods, and 
Step by Step School for Early Learning have given permission to conduct our 
research in the facilities. 
 
14.2 
Internal PSU Committee Approvals 
 
N/A 
 
15.0 Adverse Event Reporting 
 

12 
 
 
15.1 
Reporting Adverse Reactions and Unanticipated Problems to the 
Responsible IRB 
 
In accordance with applicable policies of The Pennsylvania State University 
Institutional Review Board (IRB), the investigator will report, to the IRB, any 
observed or reported harm (adverse event) experienced by a subject or other 
individual, which in the opinion of the investigator is determined to be (1) 
unexpected; and (2) probably related to the research procedures. Harms 
(adverse events) will be submitted to the IRB in accordance with the IRB policies 
and procedures. 
 
16.0 Study Monitoring, Auditing and Inspecting 
 
16.1 
Auditing and Inspecting 
 
The investigator will permit study-related monitoring, audits, and inspections by 
the Penn State quality assurance program office(s), IRB, the sponsor, and 
government regulatory bodies, of all study related documents (e.g., source 
documents, regulatory documents, data collection instruments, study data etc.).  
The investigator will ensure the capability for inspections of applicable study-
related facilities (e.g., pharmacy, diagnostic laboratory, etc.). 
 
17.0 Future Undetermined Research: Data and Specimen Banking 
 
17.1 
Data and/or specimens being stored 
 
N/A 
 
17.2 
Location of storage 
 
N/A 
 
17.3 
Duration of storage 
 
N/A 
 
17.4 
Access to data and/or specimens 
 
N/A 
 
17.5 
Procedures to release data or specimens 
 
N/A 
 
17.6 
Process for returning results 
 
N/A 
 

13 
 
 
18.0 References 
 
Bouhlal, S., Issanchou, S., & Nicklaus, S. (2011). The impact of salt, fat and sugar levels 
on toddler food intake. British Journal of Nutrition, 105(4), 645-653. 
 
Ishdorj, A., Capps Jr, O., Storey, M., & Murano, P. S. (2015). Investigating the 
relationship between food pairings and plate waste from elementary school lunches. 
Food and Nutrition Sciences, 6(11), 1029-1044. 
 
Kral, T.V., Kabay, A.C., Roe, L.S., & Rolls, B.J. (2010). Effects of doubling the portion 
size of fruit and vegetable side dishes on children's intake at a meal. Obesity, 18(3), 521-
527. 
 
Mathias, K.C., Rolls, B.J., Birch, L.L., Kral, T.V., Hanna, E.L., Davey, A., & Fisher, J.O. 
(2012). Serving larger portions of fruits and vegetables together at dinner promotes 
intake of both foods among young children. Journal of the Academy of Nutrition and 
Dietetics, 112(2), 266-270. 
 
Nicklaus, S., Boggio, V., Chabanet, C., & Issanchou, S. (2004). A prospective study of 
food preferences in childhood. Food Quality and Preference, 15(7-8), 805-818. 
 
Ramsay, S.A., Eskelsen, A.K., Branen, L.J., Armstrong Shultz, J., & Plumb, J. (2014). 
Nutrient intake and consumption of fruit and vegetables in young children. ICAN: Infant, 
Child, & Adolescent Nutrition, 6(6), 332-344. 
 
Sanchez C.E., Roe L.S., Keller K.L., Smethers A.D., Meehan C.T., Rolls B.J. (2019). 
Does serving a larger proportion of vegetables and fruit influence children’s intake over 5 
days? Poster presented at Obesity Week.  
 
Smethers, A.D., Roe, L.S., Sanchez, C.E., Zuraikat, F.M., Keller, K.L., Kling, S.M., & 
Rolls, B.J. (2019). Portion size has sustained effects over 5 days in preschool children: A 
randomized trial. American Journal of Clinical Nutrition, 109(5), 1361-1372. 
 
Spill, M.K., Birch, L.L., Roe, L.S., & Rolls, B.J. (2010). Eating vegetables first: the use of 
portion size to increase vegetable intake in preschool children. American Journal of 
Clinical Nutrition, 91(5), 1237-1243. 
 
U.S. Department of Health and Human Services and U.S. Department of Agriculture. 
2015–2020 Dietary Guidelines for Americans. 8th ed. December 2015. Available at: 
http://health.gov/dietaryguidelines/2015/. 
 
19.0 Confidentiality, Privacy and Data Management  
 
19.1 Which of the following identifiers will be recorded for the research project? 
Check all that apply. If none of the following identifiers will be recorded, do not 
check any of the boxes. 
 

14 
 
 
 
Hard 
Copy 
Data 
Electronic 
Stored 
Data 
Names and/or initials (including on signed consent documents) 
 
 
All geographic subdivisions smaller than a State, including street address, city, 
county, precinct, zip code, and their equivalent geocodes, 
 
 
All elements of dates (except year) for dates directly related to an individual, 
including birth date, admission date, discharge date, date of death; and all ages 
over 89 and all elements of dates (including year) indicative of such age, except 
that such ages and elements may be aggregated into a single category of age 90 
or older 
 
 
Telephone numbers 
 
 
Fax numbers 
 
 
Electronic mail addresses 
 
 
Social security numbers 
 
 
Medical record numbers 
 
 
Health plan beneficiary numbers 
 
 
Account numbers 
 
 
Certificate/license numbers 
 
 
Vehicle identifiers and serial numbers, including license plate numbers 
 
 
Device identifiers and serial numbers 
 
 
Web Universal Resource Locators (URLs) 
 
 
Internet Protocol (IP) address numbers 
 
 
Biometric identifiers, including finger and voice prints 
 
 
Full face photographic images and any comparable images 
 
 
Any other unique identifying number, characteristic, or code (such as the 
pathology number) 
 
 
Study code number with linking list 
 
 
Genomic sequence data 
 
 
State ID numbers 
 
 
Passport numbers 
 
 
Driver’s license numbers 
 
 
 
19.2 
If storing paper records of research data, answer the following questions: 
 
19.2.1 Where will the paper records, including copies of signed consent 
forms, associated with this research study will be stored? 
 
Paper records of data (food intake, food preference, height and weight, and 
questionnaires) will be stored without identifiers in locked offices in the 
laboratory. 
 
Consent forms will be stored in a locked closet in the lab manager’s office 
within the laboratory office. Only those listed on the IRB application will have 
access to these files. 
 
19.2.2 How will the paper records be secured?  
 
Consent forms will be stored in a locked closet in the lab manager’s office 
within the laboratory office. Only those listed on the IRB application will have 
access to these files. 

15 
 
 
 
Paper records of data (food intake, food preference, height and weight, and 
questionnaires) will be stored without identifiers in locked offices in the 
laboratory. 
 
19.2.3 How will access to the paper records be restricted to authorized 
project personnel? 
 
Consent forms will be stored in a locked closet in the lab manager’s office 
within the laboratory office. Only those listed on the IRB application will have 
access to these files. 
 
Paper records of data (food intake, food preference, height and weight, and 
questionnaires) will be stored without identifiers in locked offices in the 
laboratory 
 
19.3 
If storing electronic records of research data, indicate where the electronic 
data associated with this research study will be stored. Check all that 
apply. 
 
  Penn State-provided database application.  Check which of the following 
database applications are being used (check all that apply): 
  Penn State REDCap 
  Other – Specify - provided and approved database application:  
  Penn State, College, or Department IT file server  
Our lab has a networked storage drive which only allows access to those 
on the IRB application. Users must enter their PSU email and password to 
access this drive. Photos are kept on this drive. This drive is only visible 
to those who have permission to access it. 
  Box.psu.edu  
  Web-based system provided by the sponsor or cooperative group - 
Specify URL and contact information:  
  Other – Specify the database application or server: 
Provide details about the data security features or attach security 
documentation provided by sponsor or group: 
 
19.4 
Is there a list/key that links code numbers to identifiers?  
 
  Yes - explain how the list that links the code to identifiers is stored separately 
from coded data: 
A master list of participant ID, letter, and first name will be kept as a password-
protected document on the study coordinator’s computer. Only those listed on the 
IRB application will have access to this. A paper copy will also be kept in a locked 
closet in the lab manager’s office. This closet is locked when not occupied and only 
those listed on the application will have access to this. The code list will be 
destroyed 5 years after study completion or when the results are published, 
whichever comes first. 

16 
 
 
 
  Not applicable, there is no list that links code numbers to identifiers. Skip to 
section 19.6. 
 
19.5 
Is there a list of people who have access to the list/key? 
  Yes – explain how access to that list is restricted and why certain persons 
require access. 
Those listed on the IRB application have access to this master list. 
  No – explain why not: 
 
19.6 
Describe the mechanism in place to ensure only approved research 
personnel have access to the stored research data (electronic and paper). 
  Password-protected files 
  Role-based security  
  Specify all other mechanisms used to ensure only permitted users have 
access to the stored research data. 
Only those listed on the IRB application will have access to these files. 
 
19.7 
Will any research data (such as survey data) be collected on a mobile 
device, such as an electronic tablet, cell phone, or wireless activity 
tracker?  
  No 
  Yes - answer the following questions: 
19.7.1 Specify the provider of the mobile devices(s) 
  Supplied by the sponsor 
  Penn State owned device 
  A personal device 
  Other – Please specify source:  
 
19.7.2 Specify the type(s) of mobile device(s) that will be used to capture 
data and all identifiers captured on the mobile device(s). Please list 
all devices, and if more than one, the identifiers to be collected on 
each. 
 
19.7.3 Specify the type of data collected on the mobile devices(s).  
 
19.7.4 Specify the application or website used to collect the data from the 
mobile device, if applicable. 
 
19.7.5 Describe the measures taken to protect the confidentiality of the 
data collected on mobile device(s). Please address physical security 
of the device(s), electronic security, and secure transfer of data from 
device(s) to the previously indicated data/file storage location 
provided in section 19.3. 

17 
 
 
 
19.8 
Will any research data be directly entered/sent by subjects over the internet 
or via email (e.g., data capture using on-line surveys/questionnaires, 
surveys via email, observation of chat rooms or blogs)? 
  No 
  Yes - answer the following questions: 
19.8.1 Specify the identifiers collected over the internet or via email 
(Including IP addresses if IP addresses will be collected). 
 
19.8.2 Specify the type of data collected over the internet or via email. 
 
19.8.3 Describe the measures taken to protect the confidentiality of the 
data collected? 
 
19.8.4 Describe how the research team will access the data once data 
collection is complete. 
 
19.8.5 If the research involves online surveys, list the name(s) of the 
service provider(s) that will be used for the survey(s)  
  Penn State REDCap 
  Penn State Qualtrics (de-identified data only) 
  Other - Please specify: 
Application:  
URL (If applicable):  
 
19.8.6 If the answer above is “Other” contact security@psu.edu for 
approval of an alternative data capture method 
 
19.9 
Will any type of recordings (e.g., audio or video) or photographs of the 
subjects be made during this study? 
  No - skip to section 19.10 
  Yes - answer the following questions: 
19.9.1 What will be used to capture the audio/video/images? Give a brief 
description of content. 
  Audio – Describe the intended content of the audio recording: 
  Video – Describe the intended content of the video recording: 
  Photographs of the subjects – Describe the intended content of the 
photographs: 
Photographs may be used in presentations at scientific meetings. Only 
photographs will be used – names or other identifiable information will not 
be used with photographs.  
 

18 
 
 
There is a place on the consent form for parents to indicate whether or not 
they give permission for the use of their child’s photograph.  
 
Our lab has a networked storage drive which only allows access to those 
on the IRB application. Users must enter their PSU email and password to 
access this drive. Photos are kept on this drive. This drive is only visible 
to those who have permission to access it. 
 3-D Images – Describe the intended content of the of 3-D images: 
 Other - Specify:  
 
19.9.2 How will the recordings/photographs/images be stored 
(electronically or physically)? 
 
Electronically. 
 
19.9.3 Where will the recordings/photographs/images be stored? 
 
Images will be stored on the laboratory’s networked storage drive. Only 
those listed on the IRB application have access to this. 
 
19.9.4 Who will have access to the recordings/photographs/images? 
 
Only those listed on the IRB application will have access to the 
photographs. 
 
19.9.5 Will any of the recordings be transcribed? 
  Not applicable 
  No 
  Yes – indicate who will be doing the transcribing?  
 
19.9.6 Will the recordings/photographs be used for purposes other than 
this research study? 
  No 
  Yes - specify purpose(s) (e.g., publication, presentations, educational 
training, future undetermined research): 
Presentations at scientific meetings. 
 
19.10 Certificate of Confidentiality (COC) - Is the research biomedical, behavioral, 
clinical or other research that is funded by the National Institutes of Health 
(NIH)? 
  Yes - check one of the following:  
  The research involves human subjects as defined by the DHHS 
regulations (See Worksheet HRP-310). 
  The research involves collecting or using biospecimens that are 
identifiable to an individual. 

19 
 
 
  If collecting or using biospecimens as part of the research, there is a 
small risk that some combination of the biospecimen, a request for 
the biospecimen, and other available data sources could be used to 
deduce the identity of an individual. 
  The research involves the generation of individual level, human 
genomic data. 
Note:  If any of the 4 items above are checked, a COC is 
automatically issued by NIH and applies to the research. 
Information about the COC must be included in the consent form. 
  No - answer the following question. 
If the research is not funded by NIH, will the investigator apply for a COC 
for this research study?  
  No 
  Yes 
Note:  For research not funded by NIH, the IRB may require a COC if 
the research is collecting personally identifiable information and the 
information is sensitive and/or the research is collecting information 
that if disclosed could significantly harm or damage the subject.  
 
19.11 What steps will be taken to protect subjects’ privacy interests? (Check all 
that apply.) 
  Identification and recruitment of potential subjects follows procedures 
consistent with privacy standards 
  Consent discussion and research interventions will take place in a private 
setting 
  Limiting the information being collected to only the minimum amount of data 
necessary to accomplish the research purposes  
  Limiting the people with access to the identifiable research data to the 
minimum necessary as specified in the application and consent process 
  Other – Specify:  
 
19.12 What is the process for ensuring correctness of data entry? 
  Double data entry to reduce risk of errors 
  Electronic edit checks to ensure data being entered are not obviously 
incorrect 
  Random internal quality and assurance checking of research data 
  Direct entry by subjects 
  Other - Specify:  
 

20 
 
 
19.13 Does this research involve the generation of large-scale human genomic 
data as defined in NIH Genomic Data Sharing Policy (http://gds.nih.gov)? 
  No 
  Yes – If Yes, describe the plan for de-identifying the dataset before sharing it 
with NIH-designated data repositories.  
 
19.14 The European Union (EU) General Data Protection Regulation (GDPR)  
 
19.14.1 To determine if the research is subject to the GDPR answer the 
following questions: 
 
19.14.1.1 Will the Penn State principal investigator, or another 
entity under the Penn State principal investigator’s 
direction, be collecting, recording, storing, using, any 
personal data* of any subjects physically located in the 
European Economic Area (EEA)** at the time of data 
collection (even if the subject is NOT an EEA resident) or 
any EEA citizens? (This includes recruitment through 
social media sites, use of third party internet sites, mobile 
devices or apps to collect data, and/or direct receipt of 
data from subjects.) 
  No 
  Yes (This research may be subject to the GDPR) 
 
19.14.1.2 Does this research involve the transfer of personal data 
collected under the GDPR from an EEA country? (This 
includes direct transfer of data from research 
collaborators.) 
  No 
  Yes (This research may be subject to the GDPR) 
 
19.14.2 If the research may be subject to the GDPR as indicated in the 
answers to the questions above, answer the following: 
19.14.2.1 Will any of the data fall into one of the following 
categories: health data, racial or ethnic origin, political 
opinions, religious or philosophical beliefs, trade union 
membership, genetic data, biometric data used for 
purpose of identifying an individual, sex life or sexual 
orientation? 
  No 
  Yes 
 
19.14.2.2 Will any of the data be related to criminal convictions or 
offenses? 
  No 
  Yes 
Comments on any of the above responses: 
 

21 
 
 
* “Personal data” means any information relating to an identified or identifiable natural 
person; an identifiable natural person is one who can be identified, directly or 
indirectly, by reference to an identifier such as a name, an identification number, 
location data, an online identifier or to one or more factors specific to the physical, 
physiological, genetic, mental, economic, cultural or social identity of that natural 
person. 
** European Economic Area (EEA) – Includes the 28-member states of the European 
Union (Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, 
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, 
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, 
Slovakia, Slovenia Spain, Sweden, UK) and Norway, Iceland, Lichtenstein.  
 
19.15 Does this research involve transfer or disclosure of data and/or specimens 
to and/or from Penn State? 
  No - skip the remainder of section 19.15.