Healthy Start to Feeding Pilot Trial
Phase: NA
Conditions: Weight, Body, Diet Habit
Sponsor: University of Cincinnati

College of Arts and Sciences 
Department of Psychology  
University of Cincinnati  
Cincinnati, OH, 45221   
Official Title: Healthy Start to Feeding Pilot Trial 
Brief Title: Healthy Start to Feeding Intervention  
NCT Number: NCT03597061  
Document Date: 7/9/18  
Date Uploaded: 6/24/21
Document: Study Protocol  

 
 
Protocol Version 2 (7-9-18).doc   
 
Page 2 of 14 
UNIVERSITY OF CINCINNATI 
INSTITUTIONAL REVIEW BOARD – SOCIAL AND BEHAVIORAL SCIENCES (IRB-S) 
PROTOCOL 
 
TITLE: 
Healthy Introduction of Complementary Foods: An Obesity Prevention Program 
 
1. PURPOSE of the research project AND GENERAL INFORMATION: 
a. PURPOSE 
The purpose of this research study is to pilot test a prevention program to promote healthy 
introduction of solid foods and healthy weight gain among infants. Introduction of 
complementary foods (i.e., foods besides formula or breast milk) represents a major dietary 
milestone for infants, but there are currently no empirically-derived guidelines for how parents 
should introduce solid foods to their infants. The current study will test the feasibility of a 3-
session intervention encouraging healthy introduction of complementary foods and use of a 
responsive feeding approach. Feasibility of the intervention and the impact of the Healthy Start 
to Feeding (HSF) intervention on obesity risk factors and growth will be explored. This will be 
achieved through exploration of the following aims and hypotheses: 
Aim 1: Determine feasibility of the intervention and family satisfaction with the treatment. 
H1: Families assigned to the intervention condition will attend > 67% of treatment sessions. 
H2: Families receiving the intervention will rate the program as helpful and consistent with the 
families’ needs and priorities.   
Aim 2: Test the impact of the HSF intervention on growth trajectories, appetite regulation, and diet 
at post-treatment. 
H1: Infants receiving the intervention will experience lower incidence of high weight-for-length (> 85th 
percentile) compared to infants in the control condition.   
H2: Infants in the treatment condition will show greater satiety responsiveness and lower food 
responsiveness as assessed through a well-validated parent-report measure (Baby Eating Behavior 
Questionnaire (Llewellyn, van Jaarsveld, Johnson, Carnell, & Wardle, 2010).  
H3: Infants in the treatment condition will consume a greater variety of fruits and vegetables than infants in 
the control condition as assessed through a food frequency questionnaire completed by parents. 
 
b. BACKGROUND 
1) Prior research 
Pediatric obesity occurs at epidemic rates (Ogden, Carroll, Kit, & Flegal, 2014) with significant 
health, financial, and psychosocial consequences (Weiss & Kaufman, 2008; Williams, Wake, 
Hesketh, Maher, & Waters, 2005; Griffiths, Parsons, & Hill, 2010; Freedman, 2007). While many 
treatments for pediatric obesity exist, obesity remains intractable for many children, and most 
children participating in treatments do not exhibit clinically meaningful reductions in Body Mass 
Index. Therefore, prevention of obesity is critical, including prevention efforts within the first year 
of life. Children with severe obesity begin to deviate in their growth trajectories at as early as 4 
months of age (Smego et al., 2017). Infants with high weight-for-length have up to a 9 times 
greater risk of obesity later throughout the lifespan, even until 60-70 years of age (Baird et al., 
2005; Eriksson, Forsen, Osmond, & Barker, 2003). However, effective prevention programs 
targeting children < 2 years are limited (Blake-Lamb et al., 2016).  

 
 
Protocol Version 2 (7-9-18).doc   
 
Page 3 of 14 
Interventions promoting use of responsive feeding (RF) practices have shown promise in 
reducing obesity-risk among young children (Savage et al., 2016). RF is characterized by 
parental attunement to child hunger and feeding cues and use of these cues by parents to 
structure and make decisions about feeding situations. Responsive parents offer foods when 
indicated by child hunger cues and allow children’s own satiety cues to determine when a 
feeding is complete, rather than pressuring children to eat the amount of food pre-determined by 
the parent. Responsive parenting is hypothesized to reduce obesity-risk by allowing children to 
develop awareness and responsiveness to their own satiety cues. However, the concept of RF 
has rarely been applied to the key dietary transition of introduction to complementary foods. 
Research on the introduction of complementary foods and infant weight gain has predominantly 
focused on the timing of introduction with little research exploring the potential impact of 
weaning style or the manner in which complementary foods are introduced, including whether a 
RF approach to introduction of complementary foods results in reduced obesity risk. There are 
currently no empirically-derived recommendations for parents on how to introduce 
complementary foods to infants. 
 
2) Significance 
Early infant growth patterns and eating behaviors have been related to life-long increases in 
obesity-risk. However, effective interventions for preventing excess weight gain in infancy are 
lacking. Additionally, there are currently no empirically-derived recommendations around the 
critical infant dietary milestone of introduction of solid foods. This is significant given that timing 
and manner of introduction of solid foods has potential implications for later obesity-risk 
throughout childhood, adolescence, and adulthood. If the designed prevention program is 
effective, it will reduce early obesity-risk, improve development of infant satiety cues, and 
increase infant preference for food variety. Given obesity is related to poor long-term health and 
psychosocial outcomes, financial burden, and reduced quality of life, an early life obesity 
prevention program could have significant impact across multiple domains.   
 
c. FUNDING  
1) Sponsor's name and type 
This study will be funded using the PI’s UC start-up funding and funding from UC’s University 
Research Council (an internal faculty grant).  
 
2) Sponsor's role 
The study was developed without input of a sponsor. Study results will also be analyzed, 
interpreted, and disseminated without input of a sponsor.  
 
3) Location of funds 
Funds will be held at UC’s Psychology Department.  
 
4) Status of funding 
Funding has been approved. 
 
d. FACILITIES 
Baseline and post-treatment study visits to collect outcomes measures will occur at the 
Schubert Research Clinic (SRC) located in the T-building at Cincinnati Children’s Hospital 

 
 
Protocol Version 2 (7-9-18).doc   
 
Page 4 of 14 
Medical Center (CCHMC). Intervention sessions will occur at the PI’s research lab (the Healthy 
Kids Lab) located in the Edwards Center on UC Main Campus. We have been approved for 
access to these facilities.  
 
e. DURATION OF STUDY 
The research project will take 12 months to complete.  
 
Timeline 
 
Grant 
Mos: 
1-2 
Grant 
Mos: 
3-4 
Grant 
Mos: 
5-6 
Grant 
Mos: 
7- 8 
Grant 
Mos: 
9-10 
Grant 
Mos: 
11-12 
Recruitment (at child age 2-3 mos) 
 
 
 
 
 
 
Initial Study Visit (at child age 3 mos) 
 
 
 
 
 
 
Treatment Session 1 (at child age 4 mos) 
 
 
 
 
 
 
Treatment Session 2 (at child age 6 mos) 
 
 
 
 
 
 
Treatment Session 3 (at child age 9 mos) 
 
 
 
 
 
 
Final Study Visit (at child age 9 mos) 
 
 
 
 
 
 
Abbreviations: mos = months 
 
f. RESEARCH TEAM 
1) Research team and time commitment  
 
Job Title / Responsibility 
Time Commitment 
PI 
10 hr/per wk 
Lead Undergraduate Research Coordinator 
10 hr/per wk 
Graduate Student Interventionists 
10/hr per wk 
Expert Consultants 
< 5/hr per wk 
 
2) Training team members in research ethics 
All study team members have complete and up-to-date CITI training.  
 
3) Training team members in research activities 
(a) Training 
The lead research coordinator and study interventionists will receive direct supervision from the 
study PI on study recruitment, the study intervention, and study data collection procedures. The 
lead research coordinator, study interventionists, and study PI will meet weekly for supervision.  
 
(b) Verification 
The study PI will verify appropriate use of IRB-approved forms and study procedures during 
weekly supervision with team members.  
 
2. PARTICIPANTS: 
a. RECRUITMENT 
Participants will be recruited at 2-3 months of age through Pediatric Associates, PSC, a 
pediatrician practice that has 3 locations in northern Kentucky. If adequate enrollment cannot be 
achieved through Pediatric Associates, an amendment will be submitted to expand recruitment 

 
 
Protocol Version 2 (7-9-18).doc   
 
Page 5 of 14 
to include daycares, Sona system (i.e., student participants can enroll if they have a child 
meeting study inclusion criteria), and internet and social media sites for our research lab (i.e., 
The Healthy Kids Lab).  
1) Number of participants 
The study will enroll 40 total participants. Twenty participants will be randomized to receive the 
study treatment and 20 participants will be randomized to the control group.  
 
(b) Rationale 
This number of participants was determined based on the number of participants feasible to 
enroll as part of a pilot study while still generating enough data regarding treatment feasibility.  
 
2) Inclusion and exclusion criteria 
Participants will be infants aged 3-9 months and their families (n = 40). Infants with both normal 
and elevated weight-for-length will be enrolled. Inclusion criteria include 1) infant has not 
previously been introduced to complementary foods (i.e., any food besides formula or 
breastmilk), 2) infant does not have a known developmental delay, 3) infant does not have 
impaired fine or gross motor skills (which would impact ability for self-feeding), 4) infant does not 
have a condition currently impacting their feeding and eating, 5) infant born at > 38 weeks 
gestation, 6) infant current weight-for-length > 10th percentile (Infants with suboptimal growth will 
be excluded due to potential safety implications of modifying eating and feeding styles of infants 
with growth difficulties), and 7) parent is a fluent English speaker (because this is the language 
the intervention will be delivered in).  
 
3) Vulnerable participants 
 (a) 
Vulnerability 
All study participants will be children less than 1 year old.  
 
(b) Rationale 
The objective of the current study is to test an intervention for healthy infant 
feeding. Therefore, all participants are required to be infants.  
 
(c) Confirmation 
 
A trained research assistant or study PI will complete the informed consent 
process with a parent/legal guardian of each participant. During that process, the 
research assistant will confirm that the legal guardian is 18 years of age or older by 
asking parents to self-report age if they are a young adult believed to be close to 18 
years of age. During the consent process, they will also inform the study PI if they 
have any concerns about a participant’s cognitive ability to consent.  
 
4) Risks and discomforts from participating 
(a) Type and level of risk or discomfort 
Risk or Discomfort 
Level 
Parental emotional discomfort (anxiety, nervousness) 
related to introducing their children to solid foods. 
minimal 
Child risk for choking during introduction of solid foods. minimal 

 
 
Protocol Version 2 (7-9-18).doc   
 
Page 6 of 14 
However, prior research has demonstrated that infant 
self-feedings are not associated with increased risk of 
choking (Fangupo et al., 2016).   
Child risk for growth faltering. However, prior research 
has demonstrated that children introduced to solid 
foods incorporating self-feeding are not at increased 
risk for growth faltering in comparison to other children 
(Townsend & Pitchford, 2012). 
minimal 
 
 (b) 
Safety monitoring plan  
Despite no greater than minimal risk to participants, we will still actively assess for 
adverse events related to growth faltering and choking. At each intervention 
session or study visit, study participants will report on if there were any choking 
episodes since the last meeting. Additionally, child weight will be measured, with 
any child failing to gain weight since the last session defined as an adverse event. 
Between sessions or meetings, parents will be advised to call 911 immediately if 
their child experiences a choking episode. Participants will also be informed to 
contact the study PI if there is any concern regarding their child’s weight gain or 
after a choking episode occurs. Any reports of choking episodes provided either at 
study visits or between study visits will be recorded on the Choking Incident Form. 
All reported adverse events will be assessed by the study PI.  
 
(c) Reporting 
Research assistants collecting adverse event information at study visits and 
intervention sessions will report this information directly to the PI. Between 
visits and sessions, study participants will be asked to communicate to the 
study PI directly if they have any concerns about study participation or if their 
child experiences an adverse event.  
 
(2) Notification of IRB 
Serious adverse events will be reported to the IRB immediately. Other adverse 
events will be reported to the IRB during the study renewal period.  
 
(3) Other notification 
Although not expected, if in the unlikely event we deem participation in the 
intervention group to be associated with increased risk for choking or growth 
faltering, study participants will be made aware of this increased risk immediately.  
 
(4) Available resources  
During the consent visit, all study participants will receive safety information 
regarding choking and growth faltering. Study participants will also be referred to 
talk with their child’s pediatrician if they have any concerns.   
 
5) Direct benefits to the participant 
Study participants randomized to the intervention group will receive psychoeducation 
and practice in treatment sessions regarding introduction of complementary foods to 

 
 
Protocol Version 2 (7-9-18).doc   
 
Page 7 of 14 
their child. Study participants randomized to the control group will have no direct 
benefit. Given initial introduction of solid foods occurs only at one time point, a wait-list 
control design would be inappropriate for the current study.  
 
6) Recruitment activities 
(a) Recruitment materials 
List: Study Flyer 
Pediatrician Recruitment Letter 
 
(b) Personnel 
The study PI, lead research coordinator, graduate student interventionists, and 
expert consultants will be involved in recruitment.  
 
(c) Recruitment activities  
We will use opt-in recruitment strategies across all patients at Pediatric Associates, including 
having handouts for providers to give to patients, having study posters hung at the office, and 
posting about the study on the practice’s social media and in newsletters. Physicians will then 
be given the option to also have an opt-out recruitment strategy used with the patients for which 
they are the primary medical provider. Physicians will be approached about using the opt-out 
strategy by Dr. Bolling, a physician at the practice who is also a collaborator on this research 
project. The opt-out recruitment strategy will identify children via a systematic chart review by 
research personnel and practice staff using a procedure from our previous research study 
(CCHMC 2016-1712). The pediatrician practice has a HIPAA Compliance Officer. In accordance 
with HIPAA policy, a waiver for review of the information in the primary care office charts and 
database will be placed on file with this officer. This waiver is between the pediatrician practice 
and researchers. A file will be kept for patients whose records were reviewed of the study 
personnel’s access to their medical record for purposes of inviting participation into the study 
protocol.  This procedure is consistent with HIPAA legislation (Subpart E Section 164.513, 45 
CFR 164.512). A copy of the HIPAA waiver form has been uploaded to the IRB Smartform. For 
families of children meeting the inclusion and exclusion criteria based upon information in the 
chart review, the research personnel will create a recruitment letter for each identified child’s 
pediatrician to review and sign inviting the child’s guardians to learn more and participate in a 
screening for the study. Letters will only be sent until our enrollment target is met (n = 40). 
Enclosed with the recruitment letter, families will receive a flyer describing the study and a return 
addressed, stamped “do not contact” postcard that a family can mail requesting not to be 
contacted. All families for whom a postcard is not received within 10 days of mailing will be 
contacted by phone by the study personnel to explain more about the study, assess the family’s 
interest in participation in the study, and schedule an initial study visit if the family would like to 
participate. No patient data will be removed from the pediatrician office on children for whom a 
chart review was conducted or those whose families were sent letters, until 10 days after the 
mailing. Ten days after mailing, the names, chart review screening forms, and contact 
information of families who received a recruitment letter and did not return a “do not contact” 
postcard will be brought to Dr. Stough’s lab at UC. These families will be called by study 
personnel to explain the study, conduct initial screening, and invite participation. All of these 
procedures are consistent with the recruitment procedures in our other study (CCHMC 2016-
1712).  

 
 
Protocol Version 2 (7-9-18).doc   
 
Page 8 of 14 
 
(d) Participant response 
Study flyers will include the PI’s contact information.  
 
b. CONSENT PROCESS 
1) Presenting information to potential participants 
The informed consent process will occur individually with families at their first study visit. 
It will occur first thing in the visit before any study procedures. A trained research 
assistant or the PI will review the consent form with the parent participating with the infant 
and answer parent questions regarding the research study. The parent will be given 
adequate time to determine whether they would like to participate in the study and will 
than provide consent if they choose to participate on the informed consent document. 
Information will be presented in a manner that is understandable to the family. 
 
2) Answering questions from potential participants 
Participants will complete the informed consent process one-on-one and in-person with 
research staff, allowing them the opportunity to ask questions. Families will also be 
provided contact information for the study PI should they have questions after their initial 
visit.  
 
3) Indicating consent 
Participants will sign an informed consent document to indicate their consent.  
 
4) Legally authorized representative (LAR) for minors or cognitively impaired participants 
Not applicable.  
 
5) Verification of LAR for cognitively impaired participants 
Not applicable 
 
6) Avoiding coercion 
The research assistant or PI conducting the informed consent process will be someone 
who has no authority over participants. Participants will be informed that their choice to 
participate will have no influence on their ability to receive services at Pediatric 
Associates.   
 
7) Recruitment incentives 
All study participants will receive $50 in gift cards for completion of the first study visit 
and $50 in gift cards for completion of the final study visit.  Participants will be given 
the portion of the incentive earned at the end of each completed visit (i.e., $50 at the 
end of the first study visit, $50 at the end of the final visit). 
 
c. CONSENT DOCUMENTS (ICDs)  
List: Informed Consent Document 
 
3. RESEARCH-RELATED ACTIVITY: 
a. SECONDARY ANALYSIS of an EXISTING DATASET 

 
 
Protocol Version 2 (7-9-18).doc   
 
Page 9 of 14 
Not applicable. 
 
b. REVIEW OF RECORDS that were collected for NON-RESEARCH PURPOSES 
 
 
Not applicable. 
 
c. RESEARCH ACTIVITIES 
1) Privacy of participation 
It is not necessary to keep the fact that an individual is participating private. A person 
participating in this study is only an indicator that they have an infant, and does not disclose 
anything else about the person that needs to be kept private.  
 
2) Confidentiality of data 
Data will be kept private by using a study ID number instead of the participant’s name on the 
research forms. We will keep a master list of names and study ID numbers in a separate 
location from the research forms. We will limit access to research data to the research team. 
Participants’ identities and information will be kept confidential unless the authorities have to be 
notified about abuse or immediate harm that may come to the participant or others (e.g., report 
of child abuse to Child Protective Services).  
 
Data will be kept in Dr. Stough’s research lab at UC. Paper copies of data will be kept in a 
locked filing cabinet in the PI’s research lab at UC, and electronic data will be stored on either 
password protected computers or a secure network drive. Audio recording of treatment sessions 
will be stored electronically on the secure UC network drive. These will be stored in a separate 
folder from any other participant data or names. Only study staff will have access to these 
recordings. The document linking study ID numbers to participant names and the consent forms 
will be stored separately from study data. All data will be de-identified following completion of 
study analyses and publication with the exception of the document linking study ID numbers to 
participant names and the audio recordings, which cannot be deidentified based on the nature 
of the data. Paper copies of data, consent forms, and the document linking study ID numbers to 
participant names will be destroyed through secure shredding 5 years following the last 
publication of study results in compliance with American Psychological Association 
recommendations. The data from this research study may be published; but participants will not 
be identified in publications.  
 
3) Research-related activities 
(a) Participant cohorts 
Study participants will be assigned to either the control or treatment condition at their first study 
visit following completion of informed consent and baseline measures. A computer-generated 
random number list will be used to determine condition assignment for each participant. 
Participants will be notified immediately at the study visit of their study condition.  
 
(b) Activities and duration 
The first study appointment will occur when the infant is 3 months of age (defined as 3 months 0 
days – 3 months 30 days) at the Schubert Research Clinic (SRC) at CCHMC. The infant and at 
least one parent will attend the appointment. The appointment will begin with completion of the 
informed consent process with the study PI or trained research assistant. Next, participants will 

 
 
Protocol Version 2 (7-9-18).doc   
 
Page 10 of 14 
complete study measures, including infant anthropometrics and parent-report measures of 
demographics, parental feeding practices and beliefs, and infant appetite. Families will also 
receive information about how to intervene if their child experiences a choking incident while 
introducing complementary foods. Following completion of study measures, families will be 
randomized to either the control or treatment condition using a computer-generated random 
number list. Participants will receive $50 for completion of this visit. Participants in the 
intervention condition will be instructed to not introduce their child to complementary foods prior 
to their first Treatment Session at 4 months of age. All families will receive safety information 
regarding monitoring infant growth and choking. 
Participants assigned to the treatment condition will attend 3 intervention sessions at the 
Healthy Kids Lab, located in the Edwards Center on UC campus. The sessions will be 
scheduled with individual families when the child is 4 months (+/- 30 days), 6 months (+/- 30 
days), and 9 months (+/- 30 days) of age. An attendance log of whether participants attend 
treatment will be kept.  
All participants will also complete a final study visit at the SRC at CCHMC when the child is 9 
months (+/- 30 days) of age. They will complete a final study visit to complete post-treatment 
period measurements, which will include infant anthropometrics and parent-report of infant 
appetite, infant diet, and parental feeding practices and beliefs. Families receiving the 
intervention will also complete a measure of treatment satisfaction. Participants will receive $50 
for completion of this visit.  
Healthy Start to Feeding (HSF) Intervention 
The HSF intervention provides parent education and skills training on a responsive feeding 
approach to introduction of healthy foods in infancy through 3 sessions when the child is 4, 6, 
and 9 months. Each session content is manualized and administered by interventionists with 
expertise in child development and behavioral strategies for managing child eating behaviors 
under the supervision of a licensed clinical child psychologist and pediatric occupational 
therapist with expertise in infant eating behavior and oral motor skills. Sessions are conducted 
individually with each infant participant and at least one of their primary caregivers at PI 
Stough’s research lab and include educational content, handouts and instructions, modeling of 
skills by the interventionist, caregiver practicing of skills in session, establishment of behavioral 
goals, and problem solving barriers to implementation of treatment content. Content will include: 
delaying introduction of solid foods until 6 months of age, allowing infants’ own hunger and 
satiety cues to guide the feeding experience, introducing healthy foods (e.g., fruits, vegetables, 
not junk food), parental attunement to infant satiety cues, reducing choking risk, and promoting 
infants’ own self-feeding.  
All intervention sessions will be audio recorded using a portable handheld digital audio recorder 
for use specifically for this study. Audio recordings are being obtained in order to assess 
treatment fidelity and whether interventionists cover the manualized content at each session. 
After the sessions are recorded, they will be transferred from the audio recording device to the 
secure UC storage network. One-third of sessions will be coded for treatment fidelity 
independently by two research assistants who did not provide intervention sessions. Reliability 
of coding will be calculated by comparing coding of the two research assistants.  
If a participant withdraws participation from the study or can no longer be reached/contacted 

 
 
Protocol Version 2 (7-9-18).doc   
 
Page 11 of 14 
about study participation, all data already collected for that participant will continue to be used 
for the study. The alternative to participating is to not participate.  
 
Participants may potentially be asked to participate in future studies examining the long-term 
outcomes of participation in our intervention. Conducting this future study, and subsequently the 
invitation of participants to enroll in this future study, is currently uncertain and will be 
determined in the future based on results of the current study and subsequent funding. 
Participants will be made aware of the possibility of being asked to participate in future research 
during the consent process. They can decline to be approached about future research by 
notifying the research staff member of this desire at their last study visit. Participant interest in 
being contacted for future research does not impact their ability to participate in the current 
study.  
 
(c) Data collection tools 
Infant Anthropometrics. Anthropometrics will be measured for pre-post analyses at both the 
initial and final study visit by Bionutrition Core staff at the SRC. Infant length will be measured in 
triplicate to the nearest 0.1 centimeter using an infant length board (O’Leary, Ellard 
Instrumentation, LTD). Weight will be measured in triplicate to the nearest 100 grams with the 
infant in a dry diaper using a Scale Tronix 4802 digital infant/pediatric scale. The average of the 
three measurements will be used to calculate weight for recumbent length. Percentiles for each 
infant’s weight for recumbent length will be obtained using sex and age specific World Health 
Organization (WHO) growth charts. Information will be recorded on the “Anthropometrics Form”. 
For families in the intervention condition, infants will also have length and weight measured at 
each treatment session to monitor safety of growth. Measurements will be taken by study 
interventionists using a SECA infant length board (SECA 416) and SECA infant digital scale 
(SECA 374).  
Infant and Family Demographics. Demographics information will be collected at the initial study 
visit using a form created for use in this study. 
Treatment Satisfaction. Caregivers in the treatment condition will complete a survey to provide 
quantitative and qualitative feedback on the intervention after the final treatment session. The 
questionnaire includes Likert scale ratings of the appropriateness, helpfulness, and timeliness of 
session content as well as open-ended questions for the parent to provide qualitative feedback 
on ways to improve the intervention (e.g., additional content to cover).  
Infant Appetite. Parents will complete a survey entitled the Baby Eating Behaviour 
Questionnaire (Llewellyn et al., 2010) at both the initial study visit and final study visit or final 
treatment visit to assess current infant appetite. Parents respond to 17 items on a 5-point scale. 
Scores for “Enjoyment of Food”, “Food Responsiveness”, “Slowness in Eating”, and “Satiety 
Responsiveness” are calculated.   
Block Food Frequency Questionnaire. Parents will complete the Block Food Frequency Questionnaire for 
Children Aged 0-2 at the initial and post-treatment study visits. This questionnaire asks reporters to identify 
how frequently their child has eaten a list of foods in the last week and data are analyzed by a commercial 
company NutritionQuest to produce scores for daily calorie, fat, and nutrient values. Additionally for the 
current study, we will also calculate the number of unique foods consumed by infants during the last week 

 
 
Protocol Version 2 (7-9-18).doc   
 
Page 12 of 14 
as a measure of diet variety. Participants will complete a paper booklet answer questions at the study 
visits, and these books are sent without any identifying information to NutritionQuest for processing.  
Infant Feeding Questionnaire (IFQ; Baughcum et al., 2001). Parents will complete the IFQ, which 
assesses maternal feeding practices and beliefs, at the initial and post-treatment study visits. The version 
used in the current study is adapted to assess current feeding practices and beliefs and has been used in 
prior research (McMeekin et al., 2013; Odar Stough et al., under review). The measure includes 20 items 
that assess parental beliefs: “Concern about Infant Undereating and Becoming Underweight”, “Concern 
About Infant Hunger”, “Concern about Infant Overeating and Becoming Overweight” and parental feeding 
practices: “Awareness of Infant’s Hunger and Satiety Cues”, “Feeding Infant on a Schedule”, “Using Food 
to Calm Infant’s Fussiness”, and “Social Interaction with the Infant During Feeding”. Parents respond to 
use question on a 5-point Likert scale or indicate n/a if appropriate.  
 
List: 
Anthropometrics Form 
Demographics Form 
Treatment Satisfaction Survey 
Baby Eating Behavior Questionnaire 
Block Food Frequency Questionnaire 
Infant Feeding Questionnaire 
Choking Incident Form 
 
(d) Payments to participants:  reimbursement of expenses or payment for time and 
effort 
Participants will receive $100 for participating. All study participants will receive $50 in gift cards 
for completion of the first study visit and $50 in gift cards for completion of the final study visit. 
Participants will also have the cost of parking for attending visits covered.  
 
4. DATA ANALYSIS: 
Aim 1 (Determine the feasibility of the HSF intervention and family satisfaction with the 
treatment) will be explored using descriptive analyses. We will calculate the average number of 
treatment sessions attended and the percentage of participants attending 2 (67%) and 3 (100%) 
of the sessions. Additionally, we will calculate the percentage of caregivers who either 
“somewhat agree” or “strongly agree” that the intervention is appropriate, timely, helpful, and 
satisfactory as assessed by the Treatment Satisfaction Survey. Qualitative comments on the 
Treatment Satisfaction Survey will also be reviewed to identify themes regarding additional 
information to include in the intervention, what information was most helpful, what caregivers 
would like to see changed about the intervention, and what they would like to see stay the 
same.  
Aim 2 (Examine the impact of the HSF intervention on growth trajectories, appetite regulation, 
and diet at post-treatment) will be explored through group comparisons between the control and 
treatment groups on weight-for-length scores, subscale scores of the BEBQ, and number of 
fruits and vegetables consumed in the last week as assessed on a food frequency 
questionnaire. Prior to between group comparisons, potential differences between the control 
and treatment group on key sociodemographic and baseline variables (e.g., gender, baseline 
weight-for-length, household income, caregiver education level) will be explored to confirm the 

 
 
Protocol Version 2 (7-9-18).doc   
 
Page 13 of 14 
effectiveness of randomization to treatment condition. A series of Analysis of Variance (ANOVA) 
will be computed to examine whether the control and treatment groups differ on outcome 
variables. If missing data are present, we will also consider an alternative analyses using a 
repeated measures model with maximum likelihood estimation to examine group differences on 
outcome variables, which will allow inclusion of all participants despite missing data.  
 
5.  REFERENCES: 
Baird, J., Fisher, D., Lucas, P., Kleijnen, J., Roberts, H., & Law, C. (2005). Being big or growing 
fast: Systematic review of size and growth in infancy and later obesity. Bmj, 331(7522), 929-
931. 10.1136/bmj.38586.411273.E0 Retrieved from 
http://dx.doi.org/10.1136/bmj.38586.411273.E0 
Baughcum, A. E., Powers, S. W., Johnson, S. B., Chamberlin, L. A., Deeks, C. M., Jain, A., & 
Whitaker, R. C. (2001). Maternal feeding practices and beliefs and their relationships to 
overweight in early childhood. Journal of Developmental and Behavioral Pediatrics : JDBP, 
22(6), 391-408. 
Blake-Lamb, T. L., Locks, L. M., Perkins, M. E., Woo Baidal, J. A., Cheng, E. R., & Taveras, E. 
M. (2016). Interventions for childhood obesity in the first 1,000 days A systematic review. 
American Journal of Preventive Medicine, 50(6), 780-789. 10.1016/j.amepre.2015.11.010 
Retrieved from http://www.sciencedirect.com/science/article/pii/S0749379715007503 
Eriksson, J., Forsén, T., Osmond, C., & Barker, D. (2003). Obesity from cradle to grave. 
International Journal of Obesity, 27(6), 722-727. 10.1038/sj.ijo.0802278 Retrieved from 
http://dx.doi.org/10.1038/sj.ijo.0802278 
Fangupo, L. J., Heath, A. -. M., Williams, S. M., Erickson Williams, L. W., Morison, B. J., 
Fleming, E. A., . . . Taylor, R. W. (2016). A baby-led approach to eating solids and risk of 
choking. Pediatrics, 138(4), e20160772. 10.1542/peds.2016-0772 
Freedman, D. S. (2007). Cardiovascular risk factors and excess adiposity among overweight 
children and adolescents: The bogalusa heart study. J Pediatr, 150(1), 17.e2. 
10.1016/j.jpeds.2006.08.042 Retrieved from 
http://www.sciencedirect.com/science/article/pii/S0022347606008171 
Griffiths, L. J., Parsons, T. J., & Hill, A. J. (2010). Self-esteem and quality of life in obese 
children and adolescents: A systematic review. International Journal of Pediatric Obesity, 
5(4), 282-304. 10.3109/17477160903473697 Retrieved from 
http://www.ncbi.nlm.nih.gov/pubmed/20210677 
Llewellyn, C. H., van Jaarsveld, C. H., Johnson, L., Carnell, S., & Wardle, J. (2010). Nature and 
nurture in infant appetite: Analysis of the gemini twin birth cohort. The American Journal of 
Clinical Nutrition, 91(5), 1172-1179. 10.3945/ajcn.2009.28868 [doi] 
McMeekin, S., Jansen, E., Mallan, K., Nicholson, J., Magarey, A., & Daniels, L. (2013). 
Associations between infant temperament and early feeding practices. A cross-sectional 
study of australian mother-infant dyads from the NOURISH randomised controlled trial. 
Appetite, 60(1), 239-245. doi:S0195-6663(12)00408-4 
Ogden, C. L., Carroll, M. D., Kit, B. K., & Flegal, K. M. (2014). Prevalence of childhood and adult 
obesity in the united states, 2011-2012. Jama, 311(8), 806-814. 10.1001/jama.2014.732 
[doi] 
Savage, J. S., Birch, L. L., Marini, M., Anzman-Frasca, S., & Paul, I. M. (2016). Effect of the 
INSIGHT responsive parenting intervention on rapid infant weight gain and overweight 

 
 
Protocol Version 2 (7-9-18).doc   
 
Page 14 of 14 
status at age 1 year: A randomized clinical trial. JAMA Pediatrics, 170(8), 742-749. 
10.1001/jamapediatrics.2016.0445 Retrieved from 
http://dx.doi.org/10.1001/jamapediatrics.2016.0445 
Smego, A., Woo, J. G., Klein, J., Suh, C., Bansal, D., Bliss, S., . . . Crimmins, N. A. (2017). High 
body mass index in infancy may predict severe obesity in early childhood. The Journal of 
Pediatrics, 183, 93.e1. S0022-3476(16)31249-5 [pii] 
Townsend, E., & Pitchford, N. J. (2012). Baby knows best? the impact of weaning style on food 
preferences and body mass index in early childhood in a case-controlled sample. BMJ 
Open, 2(1), e000298. 10.1136/bmjopen-2011-000298 Retrieved from 
http://www.ncbi.nlm.nih.gov/pubmed/22315302 
Weiss, R., & Kaufman, F. R. (2008). Metabolic complications of childhood obesity: Identifying 
and mitigating the risk. Diabetes Care, 31 Suppl 2(2), S316. 10.2337/dc08-s273 Retrieved 
from http://www.ncbi.nlm.nih.gov/pubmed/18227502 
Williams, J., Wake, M., Hesketh, K., Maher, E., & Waters, E. (2005). Health-related quality of life 
of overweight and obese children. Jama, 293(1), 70-76. 293/1/70 [pii] 
 
6.  ADDITIONAL DOCUMENTATION: 
Not applicable.