A Pilot-Feasibility of a Home-based Intervention to Reduce Obesity Risk for Bottle-fed Infants
Phase: NA
Conditions: Opaque Bottles, Conventional, Clear Bottles
Sponsor: California Polytechnic State University-San Luis Obispo

Cover Page 
 
A Pilot-Feasibility of a Home-based 
Intervention to Reduce Obesity Risk 
for Bottle-fed Infants 
 
 
Protocol 
 
 
Study Abbreviation 
OBS-F 
 
Project Start Date: 
 
12 August 2018 
Project End Date: 
31 July 2020 
 
Principal Investigator: 
Dr. Alison Ventura  
 
Sponsor: 
NIH, NICHD 
 
Protocol Creation: 
5 September 2018 
 
Protocol ID: 
2018-164-CP 
 
Version 
1 
 

TITLE OF THE RESEARCH: 
 
A Pilot-Feasibility of a Home-based Intervention to Reduce Obesity Risk for Bottle-fed 
Infants 
 
 
BRIEF TITLE: 
 
Opaque Bottle Feasibility Study (OBS-F) 
 
 
NAME AND DEPARTMENT/AFFILIATION OF THE PRIMARY 
INVESTIGATOR: 
 
Alison K. Ventura, PhD 
Kinesiology and Public Health Department 
College of Science and Mathematics 
 
 
STATEMENT OF PURPOSE, BENEFITS, AND HYPOTHESES: 
 
Rapid weight gain during the first year of life is a strong and consistent predictor of 
later development of obesity1 leading researchers and government bodies to call for 
obesity prevention efforts starting during infancy.2-4 Mounting evidence illustrates that 
bottle-fed infants (whether fed formula or expressed breast milk) are at significantly 
greater risk for rapid weight gain, gaining an excess of 70-90 grams/month across the 
first year when compared to their breastfed peers.5-7 While the experience of 
breastfeeding may help mothers develop feeding practices that are responsive to infant 
satiety cues because they must learn to trust their infants’ developing abilities to self-
regulate intake,8-12 bottle-feeding may facilitate controlling feeding practices due to 
mothers’ abilities to feed in response to the amount of milk in the bottle,13 leading to 
overfeeding and excess weight gain.8-12 
Public health efforts to date have focused on breastfeeding promotion programs. 
Regardless, over 50% of US infants are exclusively formula-fed at 6 months of age.14 
Moreover, 40% of breastfed infants receive supplemental formula in a bottle,15 and 70% 
receive expressed breast milk from a bottle on a regular basis.16 Despite the ubiquity of 
bottle-usage, mothers receive little to no support for learning healthy bottle-feeding 
practices17 and a paucity of research has focused on improving bottle-feeding mothers’ 
responsiveness to infant cues. Previous efforts have focused on educating mothers about 
infant cues and offering less formula during each feeding, but have shown little success 
in modifying feeding behaviors or weight gain outcomes.18 Thus, promotion of healthy 
bottle-feeding practices remains a realistic but under-utilized facet of obesity prevention 
efforts.  
In the proposed research we take a novel, pragmatic approach to promote healthy 
bottle-feeding. Our previous research has explored whether a simple intervention - 
covering bottles with an opaque, weighted sleeve – can improve maternal responsiveness 

PROTOCOL TITLE: A Pilot-Feasibility of a Home-based Intervention to Reduce 
Obesity Risk for Bottle-fed Infants 
 
 
3 
to infant cues during bottle-feeding. Indeed, in an NIH-funded, laboratory-based trial 
(R03-HD080730), we illustrated mothers show significantly greater responsiveness and 
feed their infants 26% less when using opaque, weighted bottles compared to 
conventional, clear bottles.13,19 While initially conceived as a promising adjunct to a 
larger obesity prevention approach, our laboratory findings suggest that opaque bottles 
may be a simple, yet potent, stand-alone tool for improving mothers’ abilities to feed 
responsively and reducing infants’ risk for overfeeding and rapid weight gain. In the 
proposed study, we aim to test this approach outside of the laboratory and enroll 100 
new, formula-feeding mothers and infants (< 2 weeks old) into a randomized trial to 
examine the 12-week effects of using opaque, weighted bottles versus clear bottles for 
improving bottle-feeding interactions and reducing child obesity risk. We will use pre-
established and state-of-the-art procedures to objectively measure infants’ intake and 
mothers’ responsiveness to infant cues (i.e., objective assessment of feeding patterns, 
coding of mother-infant bottle-feeding interactions) within their homes at the beginning 
and end of the 12-week study period. Intervention feasibility, fidelity, acceptability, and 
safety will be evaluated. Specific aims of the proposed research are: 
AIM 1: To test the hypothesis that mothers who use opaque, weighted bottles for a 
12-week intervention period will feed their infants less and be more responsive to 
their infants’ cues compared to mothers who use clear bottles. Intake will be 
objectively assessed via change in bottle weight before and after feeding observations. 
Responsiveness to infant cues will be coded from video-records of feeding observations 
using the Nursing Child Assessment Parent-Child Interaction Feeding Scale. 
AIM 2: To test the hypothesis that infants who are fed from opaque, weighted 
bottles will exhibit slower 12-week weight gain trajectories compared to infants 
who are fed from clear bottles. Infants’ weight, length, skinfolds, and waist 
circumference will be measured at the beginning and end of the study; weight-for-
length z-scores (WLZ) will be calculated using the WHO Growth Standards.  
AIM 3: To examine the feasibility, fidelity, adherence, acceptability (e.g., 
perceived barriers to use), and safety (e.g., feeding adequacy) of the opaque, 
weighted bottle intervention. We will collect both objective and subjective data 
related to bottle use. We will also assess mothers’ perceptions of the opaque bottles, 
any perceived barriers to their use, and whether baseline characteristics of mothers 
(e.g., weight status, race/ethnicity, socioeconomic status, parity, other non-maternal 
caregiver feeding practices and styles) and infants (e.g., sex, weight status, 
temperament) moderate intervention effects. 
The proposed study is a critical step toward understanding the potential for opaque, 
weighted bottles as a practical solution for reducing obesity risk during infancy. 
Additionally, given the demographics of our community (35% Hispanic; 34% minority 
races), we have the opportunity to test this intervention in a diverse sample that includes a 
large proportion of families of lower socioeconomic status, two major risk factors for 
unhealthy bottle-feeding practices and childhood obesity.20,21 
 
METHODS: 
Design and Sample 
Design. We have designed a 12-week randomized clinical trial to explore the efficacy 

PROTOCOL TITLE: A Pilot-Feasibility of a Home-based Intervention to Reduce 
Obesity Risk for Bottle-fed Infants 
 
 
4 
and feasibility of a 12-week opaque, weighted bottle intervention. Previous research 
suggests that, during early infancy, 12 weeks is a sufficient duration of follow-up to 
capture divergences in growth trajectories related to feeding mode, and that the window 
between 12-24 weeks is when associations between feeding mode and excess weight gain 
emerge.44 Mother-infant dyads will be randomized to use conventional, clear bottles 
(clear group) or opaque, weighted bottles (opaque group). Dyads will participate in 
home-based assessments of bottle-feeding interactions at study entry and 12 weeks, with 
brief assessments at 2 and 6 weeks. 
Subjects and Recruitment. A total of 100 mother-infant dyads will participate. We will 
use recruitment methods similar to those effectively used in our previous research.13,45-47 
Mothers will be recruited through ads in local newspapers; targeted social media ads; 
Women, Infant & Children (WIC) offices; OB/GYN and pediatrician offices; mass 
mailings; online sites; and a list of past participants who have asked to be notified of 
future studies. See Appendix 1 for example recruitment materials.  
Given San Luis Obispo and Santa Barbara Counties are predominately White and 
Hispanic (66% White, 35% Hispanic, 2% Black, and 4% Asian),48 we will over-sample 
Black mothers to increase sample diversity (targets: 55% White, 35% Hispanic, 13% 
Black, 4% Asian).49 Both English and Spanish-speaking mothers and their healthy, term 
infants of either sex will be eligible.  
Inclusion criteria for the dyads include:  
1) mothers 18-40-years of age 
2) infants <8-weeks of age 
3) mother is planning to bottle-feed, or is currently bottle-feeding, her infant 
4) mother predominantly or solely responsible for infant feeding 
5) dyad has a pediatrician and plans to attend infant well-visits 
6) mother is willing to use stainless-steel bottles and to provide the study will her 
current bottles, which would be returned after study completion 
7) prior to the introduction of solid foods 
To protect infants who might be at risk for underfeeding or inadequate growth, exclusion 
criteria for infants include known risk factors:50  
1) preterm birth (i.e., gestational age <37 weeks) 
2) low birth weight (<2500 g) 
3) maternal smoking during pregnancy 
4) current or past medical conditions that interfere with oral feeding 
5) history of slow growth or failure to thrive 
6) weight for length percentile <5th 
7) diagnosed developmental delay (e.g., Down’s syndrome) 
While we anticipate this will be rare, any mother reporting that they typically use opaque 
bottles prior to entry will also be excluded. 
Research assistants will provide study information to mothers who respond to our 
recruitment efforts. Mothers who express interest in participating in our study will be 
screened by trained research assistants to assess study eligibility (see Appendix 2 for 
screening and telephone scripts). 

PROTOCOL TITLE: A Pilot-Feasibility of a Home-based Intervention to Reduce 
Obesity Risk for Bottle-fed Infants 
 
 
5 
Procedures to Retain Sample. To promote retention, we will conduct home-based 
assessments to minimize participant burden. We will compensate participants a total of 
$100 (2 pre-test assessments @ $20 each, 2 brief intermediate assessments @ $10 each, 
and 2 post-test assessments @ $20 each; see Table). 
Randomization. Mothers will be randomized using a computer-generated randomization 
scheme. Mothers will be informed of the group to which they are randomized by 
unblinded research assistants at the end of the Home-Based Pre-Test 2 (see Table). 
Experimental Conditions 
1. Control Group: Conventional, Clear Bottles: These mothers will receive usual care 
from their pediatric providers and each mother will be given 12 conventional, clear 
bottles of various sizes (4-12 ounces) that are compatible with a variety of different 
nipples manufactured by leading bottle companies. Mothers will also be given a 
handout about paced bottle-feeding (see Appendix 3), which includes messages about 
feeding in response to infant cues.  
2. Intervention Group: Opaque Bottles: These mothers will receive everything provided 
to the clear group, but will instead receive 12 opaque, weighted bottles of various 
sizes (4-12 ounces). These bottles will be stainless steel (Pura Kiki, California, USA) 
and compatible with a variety of different nipples manufactured by leading bottle 
companies. These bottles weigh ~70g more than comparable plastic bottles, which is 
similar to the amount of added weight used in our pilot work. Mothers in the 
intervention group will also receive a handout about how opaque bottles can help them 
attend to infant cues.  
For both groups, we will replace all of the mother’s current bottles with study bottles and 
will ensure that the study bottles match the size of the bottles the mother currently uses; 
we will also supply any additional bottles needed for infant care in other settings (e.g., 
child care). Mothers will be asked to use the study bottles for all bottle feedings, 
regardless of whether the mother or another caregiver is feeding the infant. Monthly 
phone calls from the study interventionist will query about any need to replace bottles or 
any feeding difficulties; we will also instruct the mother to contact us if she needs more 
bottles. We anticipate that the features of allowing mothers to continue using their 
preferred nipple and replacing all of the mothers’ bottles with study bottles will 
encourage compliance.  
 
Assessments and Measures 
As illustrated in the Table, we will conduct two assessments (separated by one day) at 
both study entry and completion to objectively measure infant intake and maternal 
responsiveness. Two brief visits will occur at weeks 2 and 6 to assess infant growth and 
maternal adherence to the intervention. All assessments will be administered by blinded 
research assistants.  
 
 
 
 
 

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6 
 
 
 
Home-Based Assessments. Two research assistants will visit the mother’s home in the 
morning (to control for infants’ circadian rhythms and variations in intake51) and will 
arrive approximately one hour prior to a time when an infant typically takes a bottle-
feeding. Mothers will be asked to hide all bottles prior to each visit to ensure research 
assistants remain blinded. We will call the mother the evening before each visit to assess 
whether any disruptive events that may negatively influence the infant’s behavior (e.g., 
colds, teething) occurred; if a disruptive event is reported during this phone call, the visit 
will be rescheduled. After a short acclimation period, we will interview the mother about 
when the infant last fed and slept and will conduct additional assessments. When the 
mother and infant are ready to feed, we will set-up two video cameras (GoPro Hero 4, 
California, USA) at two different angles (to obtain clear views of both the mother and the 
infant) ~10 feet in front of a location where the mother typically bottle-feeds her infant 
and will record the mother feeding her infant using clear or opaque bottles. The mother 
will be instructed to feed her infant as she normally would at home and the research 
assistants will wait in another room to minimize any possible influence on the mother’s 
or infant’s feeding behaviors. Additional questionnaires will be completed after feeding. 
Measures. We will evaluate our intervention along multiple dimensions to fully 
understand the impact of opaque bottles on feeding outcomes and the feasibility of 
scaling this intervention for larger trials. 
• Infant intake will be assessed by weighing the infant’s bottle before and after each 
feeding observation using a top-loading balance (SP601 Scout Pro Portable Balance, 
Ohaus, New Jersey, USA). We will also note the type of nipple used and will control 
for nipple flow rate in all analyses. 
• Maternal responsiveness to infant cues will be objectively assessed by video-coding 
of all feeding observations. After each visit, three trained coders who are unaware of 
the experimental conditions and hypotheses of the study will code videos using the 
NCAFS,38 a reliable and valid means of observing and rating mother-child interactions 
during a feeding session. The NCAFS is validated for use with mothers and their 0-1-
year-old infants, can be applied to a breast or bottle-feeding episodes, and has been 
used during both lab- and home-based feeding observations. It contains 76 observable 
behaviors that are organized into six subscales; for the proposed research, we will 
Table. Example Assessment Timeline and Type of Bottles Used during Feeding 
Observations 
Study Week: 
1 
1 
2 
6 
12 
12 
Assessment Type: 
Pre-
Test 1* 
Pre-Test 
2* 
Brief 
visit for 
growth 
check 
Brief 
visit for 
growth 
check 
Post-Test 
1* 
Post-
Test 2* 
Bottle used during 
observation:      
Clear Bottle Group 
 
Clear 
 
Opaque  
 
Opaque 
 
Clear  
  Opaque Bottle Group 
Opaque  
Clear  
Clear  
Opaque  
*Home-based assessments within the same week will be separated by one day; conditions will be 
counterbalanced. 

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Obesity Risk for Bottle-fed Infants 
 
 
7 
focus the Maternal Sensitivity to Infant Cues subscale. Reliability will be established 
prior to full coding of all videos. To this end, coders will code 10 common videos, and 
will double-code 10 additional videos. Inter-coder comparison of the 10 common 
videos will be used to establish inter-coder reliability. Intra-coder comparison of the 
10 double-coded videos will be used to establish intra-coder reliability. Full coding 
will not commence until a Kappa > 0.80 is reached for all coders. The PI is certified in 
this coding system and has it previously.13,19,53 
• Maternal feeding style, including responsive and pressuring feeding, will also be 
subjectively assessed at study entry and completion using the Infant Feeding Style 
Questionnaire (IFSQ; see Appendix 4), which assesses maternal behaviors (e.g., 
control) and beliefs (e.g., concern about feeding) related to infant feeding.52 This scale 
has been validated in diverse samples of mothers with young infants52 and the PI has 
used this measure in previous research.13,53 
• Infant growth will be assessed during all home-based assessments by trained research 
assistants measuring infant weight and height in triplicate using a portable infant 
scale/infantometer (models 334 and 233; Seca, Hamburg, Germany). To minimize 
bias, infants will always be weighed and measured while only wearing a clean diaper 
and prior to the observed feeding. We will use the World Health Organization (WHO) 
Anthro software version 3.0.1 (http://www.who.int/childgrowth/en/) to calculate age- 
and sex-specific weight-for-length z-scores (WLZ) based on the WHO growth 
standards. We will also assess infant adiposity by infant skin-fold thickness and waist 
circumference using standard protocols.54 
• Feasibility, Fidelity, Adherence, and Acceptability will be assessed through a 
number of objective and subjective measures (see Appendix 5). Feasibility of 
recruitment and retention will be evaluated by: (a) tracking the number of women who 
respond to advertisements, are eligible, but decline participation; (b) examining 
whether recruitment targets are met across different ethnic/racial strata; (c) assessing 
the number of participants who agree to participate but drop out or are lost to follow-
up, and determining reasons for drop out. To assess feasibility and fidelity of treatment 
conditions, interventionists will track distribution of the informational brochure (in 
each group) and brief phone calls completed. We will ask participants about any cross-
bottle usage (e.g., the clear group using opaque bottles or vice versa). Adherence will 
be assessed by mothers’ self-reports of the extent to which they used their assigned 
bottles (i.e., estimated percentage of feedings) at the 2-, 6-, and 12-week assessments. 
During these assessments, we will also assess whether infants experienced any 
illnesses that might have interfered with their typical feeding behaviors or weight gain, 
or whether mothers changed bottles, nipples, or formulas. We will also objectively 
measure bottle-usage and feeding patterns by affixing a light-weight, proprietary 
intake-tracking device to the bottoms of the bottles of all mothers within both the 
control and intervention groups. We developed this device to allow for objective and 
unobtrusive tracking of infants’ intake in free-living settings; the device tracks infant 
feeding patterns by assessing the weight of the bottle before and after each feeding and 
time stamping each feed start and end. The device is dishwasher safe and has the 
capacity to store 6-months of feeding data, thus can be used for the entire duration of 
the proposed study. Although this device is still under development, preliminary tests 
have shown it is highly valid, with measurement error <0.05 oz. Acceptability will be 

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Obesity Risk for Bottle-fed Infants 
 
 
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assessed by querying mothers about their perceptions of their bottles and any barriers 
to use of the bottles.  
• Additional potential moderators of intervention effects: We will also assess: infant 
sex; infant temperament, assessed by the Infant Behavior Questionnaire-Revised Very 
Short Form (IBQ-RVS; see Appendix 6);54 infant feeding history, including if and 
when solid foods are introduced, assessed by maternal retrospective report (see 
Appendix 7); maternal weight status, assessed using an adult scale/stadiometer 
(models 876 and 213; Seca, Hamburg, Germany) during the home-based assessments 
and through self-reported pre-pregnancy weight and gestational weight gain (see 
Appendix 8); family demographics, including parity, marital status, maternal 
education, race/ethnicity, assessed by a demographic questionnaire (see Appendix 9); 
maternal perceptions of the infant’s eating behaviors (e.g., satiety responsiveness, food 
responsiveness) via the Baby Eating Behaviors Questionnaire (BEBQ; see Appendix 
10); mothers’ parenting confidence (see Appendix 11); mothers’ level of distracted 
parenting (see Appendix 12); and non-maternal caregivers’ involvement in child 
feeding assessed using the Non-Maternal Caregivers questionnaire from the Infant 
Care, Feeding and Risk of Obesity Study,57 a measure that queries mothers about the 
frequency to which anyone, other than themselves, was responsible for feeding their 
infants on a typical day (see Appendix 13). 
 
 
 

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9 
Statistical Considerations 
Data Analysis. All quantitative analyses will be conducted using SAS v.9.4 (SAS 
Institute Inc., North Carolina, USA). Qualitative interview data will be transcribed and 
sorted into thematic categories using constant comparison within the framework of 
grounded theory.58 We will use linear regression to model the change in infant intake and 
maternal responsiveness (Aim 1) and change in WLZ, skinfolds, waist circumference 
(Aim 2) by the primary study variable of clear versus opaque group. For Aim 3, we will 
examine the feasibility, fidelity, adherence, acceptability, and safety of the intervention 
by summarizing quantitative and qualitative data related to recruitment and retention, 
mothers’ use of their assigned bottles, perceptions of and barriers to using the bottles, and 
any issues related to infant inadequate weight gain or weight loss. We will then explore 
whether variations in intervention feasibility, fidelity, adherence, acceptability or safety 
are correlated with baseline characteristics of mothers (e.g., weight status, race/ethnicity, 
socioeconomic status, parity, feeding practices and styles, non-maternal caregiver 
involvement in feeding) and infants (e.g., sex, birth weight, weight status, temperament). 
Finally, we will assess whether the effects of the intervention on infant intake, maternal 
responsiveness, and infant WLZ change are moderated by the following factors: nipple 
type; mothers’ adherence to the intervention, race/ethnicity, parity, or feeding practices 
and styles; infants’ sex, temperament, and timing of solid food introduction; and the 
extent to which non-maternal caregivers are feeding the infant. Moderation will be 
explored by including a group by moderator interaction term in the linear regression 
models used to explore Aims 1 and 2. All inferential analyses will be preceded by 
appropriate descriptive statistics and graphs to determine that assumptions for linear 
regression are satisfied. 
Power calculations. The proposed sample size (n=100) was selected so that there will be 
adequate power to test for statistical significance for study aims. Because our previous 
research has shown <10% attrition after 12 weeks, we conservatively estimate 20% of 
participants will drop out and 120 mother-infant dyads will be recruited to account for 
this predicted attrition rate. For Aim 1, which examines the impact of bottle type on 
infant intake and maternal responsiveness, there is 80% power to detect a 19.1 mL 
difference in intake and 1.32 point difference in change of NCAFS score from baseline to 
12-week follow-up between the clear and opaque groups, using α = .05. For Aim 2, 
which examines the impact of bottle type on weight for length z-scores (WLZ), there is 
80% power (α = .05) to detect a difference of 0.59 in change of WLZ from baseline to 
12-week follow-up between the clear and opaque groups. Given rapid weight gain has 
been defined as z-score change ≥0.67 SD,1,24,25 a between-group difference in WLZ 
change of this magnitude (0.59 SD) would be clinically significant. Power calculations 
are based on a pilot study for which the between-subject standard deviation for infant 
intake was 33.7 mL and for the NCAFS scales is 1.91; this calculation also assumes that 
the mothers assigned to the clear group will have a higher correlation in scores between 
baseline and 12-week follow-up (r = .55), whereas mothers assigned to the opaque group 
will have a lower correlation in scores between baseline and 12-week follow-up (r = 
.40).59,60 The latter calculation assumes the standard deviation for WLZ is 1.0, and that the 
correlation between WLZs over 12-weeks for infants is r = .45.60 
 

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Potential Risks and Plan for Data Safety and Monitoring 
Potential Risks. The risk involved in this study is considered minimal. Some infants or 
mothers may dislike using the bottles we offer during the infant-feeding study, thus may 
perceive the experience of using these bottles as unpleasant. It is also possible that an 
unintended consequence of the opaque bottles will be that mothers and caregivers under-
feed their infants, resulting in inadequate growth for their infants. Some mothers may feel 
uncomfortable answering questions about their attitudes about and concern for their 
infants’ feeding and weight gain patterns. Additionally, some dyads may experience 
discomfort related to having their feedings video-recorded or having our research staff 
present in their homes. There is also risk of breach of confidentiality given that video 
records are being collected.  
Plan for Data Safety and Monitoring. We have developed effective procedures for 
protecting participants’ safety and confidentiality. All participants will be assured that 
they have the right to opt out of any part of the study with which they feel uncomfortable. 
Additionally, we will check-in with mothers and infants frequently to monitor infants for 
insufficient growth (<20-30g/day) or weight loss. The research assistants will monitor the 
participants for adverse events, including inadequate infant growth.  
The PI will hold primary responsibility for ensuring that the proposed trial is conducted 
according to protocol and carrying out the above data safety and monitoring plan. 
However, the PI will also identify a local pediatrician to serve as the Data and Safety 
Monitor (DSM) for the proposed study. Given that feeding interactions and infant growth 
are of primary interest, we will identify a local pediatrician with particular expertise in 
this area and have several pediatricians affiliated with our research center who have this 
expertise. Once appointed, the DSM will help ensure that our protocol and intervention 
and assessment of adverse events are in line with local pediatric providers’ usual care 
plans. The DSM will meet with the PI and Co-I’s quarterly to review and evaluate the 
accumulated study data for participant safety, study conduct and progress, and alignment 
with pediatric providers’ usual care plans. The DSM will also serve as a consultant to 
assist with safety monitoring and we will also ensure that all enrolled families have a 
pediatrician with whom they regularly consult to add an additional layer of monitoring 
and protection.  
Infants who exhibit slower than expected growth will be referred to their pediatrician or 
emergency services for further consultation and will be removed from the study if the PI 
and/or DSM deem study participation harmful to the infant or family.  
We will also employ strategies we have used in previous studies to minimize discomfort, 
including having familiar research staff present in the homes during assessments, and 
moving to another room or outside the home (if another room is not available) during 
video-recorded feeding interactions. The PI has significant expertise in coding video-
recorded feeding interactions and ensuring mother and infant comfort and confidentiality 
during this process. Furthermore, all research assistants will be trained to ensure that 
assessments are conducted in a professional and nonjudgmental manner. 
Adverse events determined by the PI to be unanticipated problems involving risks to 
subjects or to others will be reported by the PI to the IRB within 10 days. Adverse events 
that are reviewed by the PI and not determined to be unanticipated problems involving 

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11 
risks to subjects or to others will be reported per IRB policy at the time of continuing 
review.  
All study personnel will be informed by the PI about any unanticipated problems 
involving risks to subjects or to others. If any protocol changes are needed, the PI will 
submit a modification request to the IRB. Protocol changes will not be implemented prior 
to the IRB approval unless necessary to eliminate apparent immediate hazards to the 
research participants. In such a case, the IRB will be promptly notified of the change 
following implementation (within 10 working days). Protocol adherence will be 
monitored by the PI during bi-monthly meetings with the research assistants. If the PI is 
made aware of an unanticipated protocol deviation, the PI will report this deviation to the 
IRB within 10 days. 
To protect participant confidentiality, all participant data will be treated as confidential. 
Our research team has significant expertise in maintaining data integrity and 
confidentiality in studies involved video records and clinical trials and will employ that 
expertise in the present study. Specifically, participants will be informed of this potential 
for breach of confidentiality, video files will be immediately downloaded to secure 
servers at respective sites and deleted from video cameras immediately. Records will be 
safeguarded according to the policies of HIPAA, our IRB, and the applicable state laws 
governing the conduct of the studies, which promote the protection of confidential health 
information. 
 
 
 
 
 

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Obesity Risk for Bottle-fed Infants 
 
 
12 
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Paul IM, Savage JS, Anzman SL, et al. Preventing obesity during infancy: a pilot 
study. Obesity (Silver Spring). 2011;19(2):353-361. 

PROTOCOL TITLE: A Pilot-Feasibility of a Home-based Intervention to Reduce 
Obesity Risk for Bottle-fed Infants 
 
 
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Paul IM, Savage JS, Anzman-Frasca S, Marini ME, Mindell JA, Birch LL. 
INSIGHT responsive parenting intervention and infant sleep. Pediatrics. 
2016;138(1). 
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Paul IM, Williams JS, Anzman-Frasca S, et al. The Intervention Nurses Start 
Infants Growing on Healthy Trajectories (INSIGHT) study. BMC Pediatr. 
2014;14:184. 
19. 
Savage JS, Birch LL, Marini M, Anzman-Frasca S, Paul IM. Effect of the 
INSIGHT responsive parenting intervention on rapid infant weight gain and 
overweight status at age 1 year: A randomized clinical trial. JAMA Pediatr. 
2016;170(8):742-749. 
20. 
Hurley KM, Cross MB, Hughes SO. A systematic review of responsive feeding 
and child obesity in high-income countries. J Nutr. 2011;141(3):495-501. 
21. 
Raiten DJ, Raghavan R, Porter A, Obbagy JE, Spahn JM. Executive summary: 
Evaluating the evidence base to support the inclusion of infants and children from 
birth to 24 mo of age in the Dietary Guidelines for Americans--"the B-24 
Project". Am J Clin Nutr. 2014;99(3):663S-691S. 
22. 
Lumeng JC, Taveras EM, Birch L, Yanovski SZ. Prevention of Obesity in Infancy 
and Early Childhood: A National Institutes of Health Workshop. JAMA 
pediatrics. 2015. 
23. 
Medicine Io. Early Childhood Obesity Prevention Policies. Washington, DC: The 
National Academies Press; 2011. 
24. 
Bernal J, Richards MP. The effects of bottle and breast feeding on infant 
development. J Psychosom Res. 1970;14(3):247-252. 
25. 
Blissett J, Farrow C. Predictors of maternal control of feeding at 1 and 2 years of 
age. Int J Obes (Lond). 2007;31(10):1520-1526. 
26. 
Crow RA, Fawcett JN, Wright P. Maternal behavior during breast- and bottle-
feeding. J Behav Med. 1980;3(3):259-277. 
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infancy and eating behaviors at 6 years of age. Pediatrics. 2014;134 Suppl 1:S70-
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Timby N, Hernell O, Lonnerdal B, Domellof M. Parental feeding control in 
relation to feeding mode and growth pattern during early infancy. Acta Paediatr. 
2014;103(10):1072-1077. 
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Processes. 1980;5(1):1-20. 
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Labiner-Wolfe J, Fein SB, Shealy KR, Wang C. Prevalence of breast milk 
expression and associated factors. Pediatrics. 2008;122 Suppl 2:S63-68. 
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Grummer-Strawn LM, Scanlon KS, Fein SB. Infant feeding and feeding 
transitions during the first year of life. Pediatrics. 2008;122 Suppl 2:S36-42. 
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Who's feeding baby? Non-maternal involvement in feeding and its association 
with dietary intakes among infants and toddlers. Appetite. 2013;71:7-15. 

PROTOCOL TITLE: A Pilot-Feasibility of a Home-based Intervention to Reduce 
Obesity Risk for Bottle-fed Infants 
 
 
14 
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Ehrle J, Adams G, Trout KK. Who's caring for our youngest children?: Childcare 
patterns of infants and toddlers. The Urban Institute;2001. 
35. 
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37. 
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38. 
Gamble D, Morse JM. Fathers of breastfed infants: postponing and types of 
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Participant Initials ________ 
15 
Informed Consent Form 
 
INFORMED CONSENT TO PARTICIPATE IN THE RESEARCH PROJECT 
 
Why are we doing this research? 
A research project for observing infant feeding interactions is being conducted by Drs. Alison 
Ventura and Suzanne Phelan in the Department of Kinesiology and Public Health at California 
Polytechnic State University, San Luis Obispo. The purpose of the study is to help us to better 
understand infant feeding during typical bottle-feeding situations. We are interested in looking at 
whether the type of bottle used influences infant feeding. What we learn from this study will help us 
to figure out how to promote healthy feeding during early infancy.   
 
What you should know about this research study: 
• Someone will explain this research study to you. 
• Whether or not you take part is up to you. 
• You can choose not to take part. 
• You can agree to take part now and later change your mind. 
• Whatever you decide it will not be held against you. 
• Feel free to ask all the questions you want before and after you decide. 
 
What will your family be asked to do? 
You and your infant are being asked to take part in this 12-week study. If you agree to participate, we 
will provide you with new bottles with which to feed your infant and we will ask you to use these 
bottles for the entire 12-week study. If you need more bottles or different sized bottles or nipple, we 
will be happy to provide those. Some mothers in this study will be given stainless steel bottles and 
some mothers in this study will be given plastic bottles; the type of bottle that you are given will be 
determined by chance. 
All study assessments will occur in your home. We will visit two times at the beginning of the study 
and end of the study (after 12 weeks). We will also briefly check-in with you after 2 and 6 weeks to 
see how everything is going. All visits will occur at the same time on all days. At the start of each 
visit, we will change your infant into a fresh diaper, then will measure his or her weight and length. 
We will also measure your weight and height.  
For the 3 days leading up to, and on the days of, the visits that occur at the beginning and end of the 
study, you will be asked to complete daily food logs of when and what you feed your infant. We will 
also call you during this 3-day period to remind you to fill out the logs and ask you about other 
feeding behaviors.   
During each home visit that occurs at the beginning and end of the study, a trained research assistant 
will ask you to bottle-feed your infant as you normally would at home using the bottles we provide. 
The entire feeding session will be video-recorded. The video-recorder will be placed at the far corner 
of the room, about 10 to 12 feet from you and your infant. The research assistant will step into 
another room during the feeding. After you feed your infant, the research assistant will ask some 
questions about the feeding and questions related to parenting experiences and your infant’s 
personality. We will also ask about infant feeding attitudes and practices, health history, and eating 
behaviors. 

 
Participant Initials ________ 
16 
How long will the study last? 
Participation for your family will occur over a 12-week period. We estimate each home visit will last 
1-2 hours, thus, participation in study assessments will take between 6-12 hours of your time.  
 
Is there any way being in this study could be bad for your family? 
The risk involved in this study is minimal. You or your infant may dislike using the bottles we offer 
during the infant-feeding study. It possible that your formula could sour or spoil if not handled 
correctly. Additionally, it is possible that your infant may be allergic to the materials used to make the 
bottles and nipples we will use in the study. You may feel uncomfortable answering questions we ask 
about your infant’s feeding and health history. You may omit any questionnaire items you prefer not 
to answer and you have the right to opt out of any part of the study at any time.  
We do not expect any other risks to participating in this study. If you or your infant should experience 
any discomfort related to this study, please be aware that you may contact Dr. Alison Ventura at 
(805) 756-5693 or akventur@calpoly.edu for assistance. 
You and your infant are not required to participate in this research and you may discontinue your 
participation at any time without penalty. If you agree to take part in the research now and stop at any 
time it will not be held against you. But, if you do not want to be part of the study, we may still keep 
and use your study information.  
What happens to the information we collect? 
To ensure your and your infant’s privacy and confidentiality, all videotapes, data sheets, and 
questionnaires with your information will be coded. When we want access to this information for 
later study, we will refer to the coded information so that your identity cannot be traced. All records 
and videotapes are kept in a locked file that only personnel have access to.   
In any written or oral presentation of research results, your identity will be kept private.  Records that 
identify you may be inspected by authorized individuals such as the Cal Poly institutional review 
board (IRB), or employees conducting peer review activities. You consent to such inspections and to 
the copying of excerpts of your records, if required by any of these representatives. All study 
personnel have been trained at Cal Poly on the rights of human subjects. They are familiar with the 
rules for handling personal information. 
 
Will being in this study help you in any way? 
We cannot promise any benefits to you or your infant from your taking part in this research. 
However, you may enjoy becoming more aware of your infant’s behaviors. You may also appreciate 
learning about new research in nutrition, food preferences, and caregiver-infant interactions. We also 
cannot promise any benefits to others from your taking part in this research. However, the findings 
from this study may help us to understand how best to promote healthy development during infancy.  
 
Will you be compensated for your time? 
If you agree to take part in this research study, we will pay you a total of $100 to compensate you for 
your time. This includes $20 for each of 4 home visits and $10 for each of 2 check-ins. Your family 
will be compensated at the end of each home visit. Your family will not be compensated for visit days 
that you do not attend because you do not show up, withdraw, or are removed from the study. 
 
Can you be removed from the research without your OK? 

 
Participant Initials ________ 
17 
The person in charge of the research study or the sponsor can remove you and your infant from the 
research study without your approval. Possible reasons for removal include: 
• If all or part of the study is stopped for any reason by the investigator or Cal Poly. 
• If participation in the study is adversely affecting your family. 
• If you fail to adhere to requirements for participation established by the researcher. 
 
Who should you contact for more information? 
If you have questions regarding this study or would like to be informed of the results when the study 
is completed, please feel free to contact Dr. Alison Ventura at (805) 756-5693 or 
akventur@calpoly.edu. 
If you have concerns regarding the manner in which the study is conducted, you may contact Dr. 
Michael Black, Chair of the Cal Poly Institutional Review Board, at (805) 756-2894, 
mblack@calpoly.edu, or Ms. Debbie Hart, Compliance Officer, at (805) 756-1508, 
dahart@calpoly.edu. 

 
Participant Initials ________ 
18 
If you agree to voluntarily participate in this research project as described, please indicate your 
agreement by signing below.  
 
 
 
 
 
 
 
Signature of Participant 
 
Date 
 
 
 
 
 
 
 
Signature of Researcher 
 
Date 
 
 
 
 
If you agree to allow your infant to voluntarily participate in this research project as described, 
please indicate your agreement by signing below. 
 
 
Name of Child Involved in this 
Research: 
 
 
 
 
 
 
 
 
 
 
 
Signature of Parent/Guardian 
 
Date 
 
 
 
 
 
 
 
 
Signature of Researcher 
 
Date 
 
Please keep one copy of this form for your reference. 
Thank you for your participation in this research!