Feeding Infants in Nova Scotia: an Exploratory Analysis of Responsive Feeding With Mother's Milk
Phase: NA
Conditions: Human Milk, Breastfeeding, Feeding Behavior
Sponsor: Mount Saint Vincent University

Responsive Feeding of Infants with Expressed Milk (REFINE) study: Protocol 
Page 1 of 20 
 
 
PROTOCOL 
 
Study Title: 
Responsive Feeding of Infants with Expressed Milk (REFINE) 
Study 
 
Version:  
Version 4.1, September 27, 2019 
 
Funding:  
Nova Scotia Health Research Foundation (Establishment Grant 
#1025) 
 
Principal Investigator: 
Kyly C Whitfield, PhD 
 
 
 
Assistant Professor, Department of Applied Human Nutrition 
 
Mount Saint Vincent University 
166 Bedford Hwy, Halifax, Nova Scotia, B3M 2J6, Canada 
 
 
 
Phone: +1 (902) 457-5978 
 
 
 
Email: kyly.whitfield@msvu.ca 
 
Statement of Compliance 
This document is a protocol for a modified, randomized cross-over trial. The study will be 
conducted in compliance with all stipulations of this protocol and the conditions of ethics 
committee approvals. I agree that the study will be conducted in accordance with the conditions 
outlined in the protocol (subject to any amendments). I have read and understood the protocol.  
 
 
KYLY C WHITFIELD 
 
 
 
Investigator’s name 
 
 
 
 
 
____________________________________ 
 
September 27, 2019.          . 
Investigator’s signature 
 
 
 
 
Date 
REFINE
Responsive Feeding of Infants with Expressed Milk

Responsive Feeding of Infants with Expressed Milk (REFINE) study: Protocol 
 
Page 2 of 20 
Table of contents  
 
Statement of Compliance .......................................................................................................... 1 
1. Study Synopsis ....................................................................................................................... 4 
1.1 Title ................................................................................................................................................ 4 
1.2 Objectives ...................................................................................................................................... 4 
1.3 Outcomes ...................................................................................................................................... 4 
1.4 Design ........................................................................................................................................... 4 
1.5 Study duration ............................................................................................................................... 4 
1.6 Sample size .................................................................................................................................... 5 
1.7 Study population: eligibility criteria .............................................................................................. 5 
2. Investigators, Study Locations, and Funding ....................................................................... 6 
2.1 Study investigators ........................................................................................................................ 6 
2.2 Study setting .................................................................................................................................. 6 
2.3 Study management ....................................................................................................................... 6 
2.4 Serious Adverse Events Committee / Data Safety Monitoring Board ......................................... 6 
2.5 Funding ......................................................................................................................................... 7 
3. Introduction, Background, and Rationale ............................................................................ 7 
3.1 Human milk: the optimal nutrition for infants ............................................................................. 7 
3.2 Feeding infants expressed human milk ........................................................................................ 7 
3.3. Responsive feeding ...................................................................................................................... 8 
3.4. Responsive feeding and infant energy intake .............................................................................. 8 
3.5. Summary: background and rationale ........................................................................................... 9 
4. Study Objectives .................................................................................................................... 9 
4.1 Primary objective ........................................................................................................................... 9 
4.2. Secondary objectives .................................................................................................................... 9 
5. Study Design .......................................................................................................................... 9 
6. Sample Size .......................................................................................................................... 10 
7. Recruitment and Eligibility ................................................................................................. 11 
7.1 Recruitment .................................................................................................................................. 11 
7.2 Eligibility criteria ......................................................................................................................... 11 
7.3 Participant withdrawal ................................................................................................................ 12 
8. Study Procedures ................................................................................................................. 12 
8.1 Indirect weights ........................................................................................................................... 12 
8.2. Infant growth monitoring .......................................................................................................... 12 

Responsive Feeding of Infants with Expressed Milk (REFINE) study: Protocol 
 
Page 3 of 20 
8.3. Questionnaires ........................................................................................................................... 13 
8.4 Mothers’ height and body composition ...................................................................................... 13 
8.5. Human milk samples ................................................................................................................. 13 
8.6 Video recording ........................................................................................................................... 13 
8.7 Interviews .................................................................................................................................... 14 
8.8. Participant remuneration ........................................................................................................... 14 
9. Adverse Event Reporting ..................................................................................................... 14 
11.1 Obtaining informed consent ...................................................................................................... 15 
11.2 Ethics ......................................................................................................................................... 15 
11.3 Confidentiality and data security ............................................................................................... 16 
11.4 Modifications to the protocol .................................................................................................... 16 
12. Use of Data, and Dissemination ........................................................................................ 17 
12.1 Academic dissemination ........................................................................................................... 17 
12.2 Layperson dissemination .......................................................................................................... 17 
13. References .......................................................................................................................... 18 
Appendix: Consent forms ........................................................................................................ 20 
 
 
 

Responsive Feeding of Infants with Expressed Milk (REFINE) study: Protocol 
 
Page 4 of 20 
1. Study Synopsis 
 
1.1 Title 
 
Responsive Feeding of Infants with Expressed Milk (REFINE) Study. Note that this study was 
funded under the title: ‘Feeding infants in Nova Scotia: an exploratory analysis of responsive feeding 
with mother’s milk’ 
 
1.2 Objectives 
 
1. To assess if the volume of human milk (HM) consumed by infants differs by feeding 
modality (bottle feeding HM versus breastfeeding), as assessed by indirect weighs at each 
feed during a 24-hour period at 6 weeks, 4 months, and 6 months. 
2. To determine whether infant anthropometric measurements (length, weight, head 
circumference) and growth rates (weight-for-age [WAZ], length-for-age [LAZ], weight-for-
length [WLZ], BMI-for-age z-scores [BAZ]) differ by self-reported usual feeding modality 
among infants exclusively consuming human milk.  
3. To objectively assess responsiveness of infant feeding practices, both at the breast and 
during bottle-feeding of HM, by video-recording feeding sessions in participant’s homes. 
4. To gain a better understanding of current infant feeding practices, including responsive 
feeding, among caregivers in the Halifax Regional Municipality (HRM), contextualize why 
women are pumping, and gain insight around how human milk is handled, stored, and 
prepared through open-ended one-on-one interviews with mothers. 
 
1.3 Outcomes  
 
The primary outcome of this study is the volume of milk consumed over a 24-hour period by 
feeding modality at 6 weeks, 4 months, and 6 months. Secondary outcomes include anthropometric 
measurements and growth rates (WAZ, LAZ, WLZ, BAZ) by usual feeding modality, 
responsiveness of infant feeding practices, and insights in current feeding practices in Nova Scotia.  
 
1.4 Design 
 
Modified, randomized cross-over study. 
 
1.5 Study duration 
 
This is a three-year project, to be completed between August 2018 and July 2021. The study 
duration for participants is approximately 20 weeks, from 6 weeks to 6 months postnatal.  
 

Responsive Feeding of Infants with Expressed Milk (REFINE) study: Protocol 
 
Page 5 of 20 
1.6 Sample size 
 
62 mother-infant dyads.  
 
1.7 Study population: eligibility criteria 
 
Mother-infant dyads are eligible to participate if: 
• 
mothers are aged 19 years or older, 
• 
dyads currently live in the Halifax Regional Municipality in Nova Scotia, 
• 
mothers have no chronic diseases, 
• 
the baby is a healthy singleton baby who is younger than 6 weeks of age, and is fed 
mother’s milk directly from the breast and from a bottle, 
• 
mothers plan to exclusively feed their baby mother’s milk up to 6 months, 
• 
mothers have an older child whom they successfully fed mother’s milk for a 
minimum of 6 months,  
• 
mothers are willing to participate in three 3-day study sessions and monthly 
measurement sessions, and 
• 
mothers provide informed consent for herself and her infant to participate. 
 
Mother-infant dyads are ineligible to participate if: 
• 
the baby was born preterm (earlier than 37 weeks gestation),  
• 
the baby was born outside the healthy weight range of 2,500 – 4,000 g (5lb 8oz to 8lb 
13oz),  
• 
the baby has a developmental delay diagnosed before the time of enrolment, 
• 
the baby is currently receiving any medical treatment, except for vitamin D 
supplementation (no more than 400 IU/day), 
• 
the mother sought prescription medical treatment for lactation (e.g. domperidone, 
antibiotics, prescription nipple ointment), or 
• 
the mother plans to move in the 6 months after starting the study. 
 
 
 

Responsive Feeding of Infants with Expressed Milk (REFINE) study: Protocol 
 
Page 6 of 20 
2. Investigators, Study Locations, and Funding  
 
2.1 Study investigators 
 
Kyly Whitfield, PhD, Principal Investigator, Assistant Professor 
Department of Applied Human Nutrition, Mount Saint Vincent University 
Halifax, Nova Scotia, Canada 
Phone: (902) 457-5978. E-mail: kyly.whitfield@msvu.ca 
 
Misty Rossiter, RD, PhD, Co-Investigator, Associate Professor  
Department of Applied Human Sciences, University of Prince Edward Island 
Charlottetown, Prince Edward Island, Canada 
Phone: (902) 620-5224. E-mail: mdrossiter@upei.ca 
  
Dr. Jennifer Brady, RD, PhD, Co-Investigator, Assistant Professor  
Department of Applied Human Nutrition, Mount Saint Vincent University 
Halifax, Nova Scotia, Canada 
Phone: (902) 457-6260. Email: jennifer.brady@msvu.ca  
 
Dr. Erna Snelgrove-Clarke, RN, PhD, Co-Investigator,  
Vice Dean (Health Sciences), Director, School of Nursing  
Faculty of Health Sciences, Queen's University   
Kingston, Ontario, Canada 
Phone: (613) 533-2669. Email: erna.snelgroveclarke@queensu.ca  
 
None of the study investigators have conflicts of interests to report.  
 
2.2 Study setting 
 
Centre for Applied Research at Mount Saint Vincent University (47 College Rd, Halifax, Nova 
Scotia, B3M 2J6), and households in Halifax Regional Municipality, Nova Scotia, Canada.  
 
2.3 Study management 
 
The Principal Investigator and Co-Investigators will oversee the coordination of the study; they will 
meet monthly, or more often if required.  
 
2.4 Serious Adverse Events Committee / Data Safety Monitoring Board  
 
There is no necessity for a Serious Adverse Events Committee or a Data Safety Monitoring Board 
(DSMB) in this modified, randomized cross-over trial because of the absence of potential adverse 
events related to the study. The ‘intervention’ in this study is simply feeding infants using one of two 

Responsive Feeding of Infants with Expressed Milk (REFINE) study: Protocol 
 
Page 7 of 20 
modalities that are already familiar to the mother and infant: feeding mother’s milk both from the 
breast and from a bottle.  
2.5 Funding 
 
This study is funded through a Nova Scotia Health Research Foundation Establishment Grant 
(#1025). The funders had no role in study design; and will not play a role in collection, management, 
analysis, and interpretation of data, writing of the report, nor the decision to submit the report for 
publication. 
 
3. Introduction, Background, and Rationale 
 
3.1 Human milk: the optimal nutrition for infants 
 
Human milk (HM) is the optimal food for infants with benefits beyond simply meeting the 
nutritional requirements of the rapidly growing infant (1,2). HM provides numerous bioactives 
including cytokines, immunoglobulins (particularly secretory IgA), and other anti-pathogenic 
components such as lactoferrin, that protect infants from bacterial and viral infections (3). It is well-
established that breastfeeding lowers the risk of infection, morbidity, and morality (4). In addition, 
breastfeeding helps promote optimal cognitive development (3). Breastfeeding is also beneficial for 
mothers, lowering the risk of ovarian and breast cancers (for every 1 year increase in breastfeeding 
duration, there is a 6% breast cancer risk reduction), and type 2 diabetes (1). For all these reasons, 
the World Health Organization (WHO) recommends exclusive breastfeeding for the first 6 months, 
and continued breastfeeding for 2 years and beyond (2).  
 
Although HM is the optimal form of infant nutrition, breastfeeding rates, especially in high-income 
countries, are suboptimal. Globally, 80% of infants receive at least some HM, however, in most 
countries only 50% of infants are exclusively breastfed to 6 months, with rates <20% in some high-
income countries (1). Almost 90% of Canadian mothers initiate breastfeeding, but by 6 months 
breastfeeding rates drop to 26% (5). Atlantic Canada has among the lowest rates of exclusive 
breastfeeding to 6 months in Canada at 23%, compared with 41% in British Columbia (5). These 
figures refer to consumption of human milk both from the breast, and expressed and fed by other 
means (e.g. by bottle). 
 
3.2 Feeding infants expressed human milk 
 
In high-income countries, expressing HM (pumping) has become commonplace, replacing some or 
all HM feedings at the breast (6). This may be attributed to technological advancements in HM 
pumps (6); stigmatization of breastfeeding, especially in public spaces (7); because it provides a break 
for mothers to leave their infants for work or other activities; and/or allows other caregivers (e.g. 
partners) to participate in infant feeding; or any number of other reasons.  
 
Although current global recommendations encourage caregivers to feed expressed HM from a cup 
or spoon (8), bottles remain the most common feeding tool in Canada. Bottle feeding gives rise to 
several issues (e.g. nipple confusion (8), potential impaired cranio-facial development (9)), however 
most importantly here, if ‘paced feeding’ is not practiced, gravity and caregivers control the feed 
with little control or effort on behalf of the infant (10).  
 

Responsive Feeding of Infants with Expressed Milk (REFINE) study: Protocol 
 
Page 8 of 20 
The Nova Scotia Department of Health and Wellness has a user-friendly Breastfeeding Basics resource 
for new mothers that promotes HM consumption at the breast, and also provides recommendations 
for HM expression, storage, and re-heating (50). However, there is little guidance on bottle feeding 
practices, other than not to prop a bottle (dental carie prevention). The Loving Care: Birth to Six 
Months resource also advises caregivers against propping bottles, again to prevent tooth decay, but 
also to prevent ear infections and choking (51).  
 
The very limited research on pumping to date has been conducted in the US, where most women 
pumped after returning to work (6). With this, we face a knowledge gap in Canada, where longer, 
government-supported maternity leaves may influence the rates of pumping and feeding HM in 
bottles, and reasoning for doing so. More trusted, evidence-based resources such as these may be 
required to provide guidance on responsive infant feeding, particularly if caregivers feed with bottles.  
 
3.3. Responsive feeding  
 
Responsive feeding is a reciprocal, appropriate, and timely reaction to verbal and non-verbal cues 
between the caregiver-infant dyad during feeding interactions (52). Responsive feeding promotes 
infant’s attention to internal hunger and satiety cues (53). Conversely, non-responsive feeding, 
typically characterized by caregiver’s controlling or pressuring feeding styles, can override these cues 
(52). Feeding at the breast is thought to instill responsive feeding behaviours, including self-
regulation of learned hunger-satiety cues, that likely carry over into childhood and beyond (11–13).  
 
Most responsive feeding research to date has compared infants consuming HM at the breast to 
infants consuming human milk substitutes (HMS; e.g. infant formula) from a bottle, which is 
problematic given the known sociodemographic differences between these groups of mothers (54). 
This mechanism among HM-fed infants, or the ‘how’ rather than the ‘what’ of infant feeding, has 
received less attention among researchers, and is the focus of this study. 
 
3.4. Responsive feeding and infant energy intake  
 
Although the WHO defines exclusive breastfeeding as consumption of HM (with no other food or 
drink) at the breast or as expressed HM (14), there is little evidence on which to base this equality in 
relation to hunger-satiety cue development.  
 
The rate of growth of infants differs between infants fed HM versus HMS (11): breastfed infants 
tend to be leaner at 12 months compared with infants fed HMS (15). Infants have an innate ability 
to self-regulate energy intake (16). The Davis Area Research on Lactation, Infant Nutrition and 
Growth (DARLING) Study, a seminal study comparing milk intake among matched infants 
consuming either HM or HMS, found that at 3, 6, 9, and 12 months, HMS-fed infants consumed 
significantly more milk than their breastfed peers (17). These findings may be related to the effort 
required to remove milk from the breast, as milk flow from bottles requires significantly less effort 
(i.e. gravity) (10). When HMS is fed, caregivers tend to feed in response to the amount of milk left in 
the bottle regardless of infant feeding cues, leading to excess energy intake (16,18).  
 
A recent analysis showed that children who were forced to finish bottles in the first 6 months of life 
had an increased odds of eating all the food on their plates at 6 years (19). In contrast, breastfed 
infants tend to lead the feed, determining when and how much to consume, because there are no 

Responsive Feeding of Infants with Expressed Milk (REFINE) study: Protocol 
 
Page 9 of 20 
visual cues for the caregiver to monitor or influence intake (11). In a small study of 25 mother-infant 
dyads, researchers found that less HMS was consumed when mothers fed from opaque, weight-
counterbalanced bottles compared to conventional clear bottles (20). Another recent report found 
that infants (n=865, 2 months old) eating from large bottles (≥6 oz) consumed 4 oz more HMS per 
day than peers drinking from smaller bottles (<6 oz) (21). More recently, distracted or ‘mindless’ 
infant feeding has been explored: caregivers distracted by other adults, children, televisions, or 
mobile devices (22) tend to increase the volume of the feed, which has been associated with more 
weight gain, compared with attentive feeding (12).  
 
3.5. Summary: background and rationale 
 
More research is required to understand whether the modality of HM consumption and responsive 
feeding practices influence the growth of infants. In this exploratory study, we aim to better 
understand the infant feeding ‘climate’ in the Halifax Regional Municipality, Canada.  
 
4. Study Objectives 
 
4.1 Primary objective  
 
OBJ1. To assess if the volume of HM consumed by infants differs by feeding modality (bottle 
feeding HM versus breastfeeding), as assessed by indirect weighs at each feed during a 24-hour 
period at 6 weeks, 4 months, and 6 months. 
 
4.2. Secondary objectives 
 
OBJ2. To determine whether infant anthropometric measurements (length, weight, head 
circumference) and growth rates (weight-for-age [WAZ], length-for-age [LAZ], weight-for-length 
[WLZ], BMI-for-age z-scores [BAZ]) differ by self-reported usual feeding modality among infants 
exclusively consuming human milk. 
  
OBJ3. To objectively assess responsiveness of infant feeding practices, both at the breast and during 
bottle-feeding of HM, by video-recording feeding sessions in participant’s homes.  
 
OBJ4. To gain a better understanding of current infant feeding practices, including responsive 
feeding, among caregivers in the HRM, contextualize why women are pumping, and gain insight 
around how human milk is handled, stored, and prepared through open-ended one-on-one 
interviews with mothers. 
 
5. Study Design 
 
This will be a modified randomized cross-over study (n=62 dyads; t=6 weeks, 4 months, and 6 
months) (see Figure 1).  
 

Responsive Feeding of Infants with Expressed Milk (REFINE) study: Protocol 
 
Page 10 of 20 
 
Figure 1. Pictorial display of the REFINE study data collection scheme.  
 
Since there is high potential for inter-infant variability in milk consumption, we will employ a 
modified randomized cross-over study design, which allows each infant to act as their own control, 
limiting potential confounding (39). This is a modified design because rather than participants in 
different ‘treatments’ consuming different foods, here the modality of HM consumption – from 
bottle or breast – will differ (see Figure 2). 
 
 
 
 
 
 
 
 
 
 
 
Figure 2: Pictorial display of OBJ1; this data collection will occur at 6 weeks, and 4 and 6 months. 
 
6. Sample Size 
 
We estimate that a sample size of 41 is required to detect a 1 oz (26 mL) difference between infants 
during feeds at the bottle and the breast, assuming a standard deviation of 50 mL, 90% power and 
an alpha of 0.05 (two samples paired means test, Stata Corp). If we used assumptions based on 
breastfeeding rates in Atlantic Canada (90% initiation, 23% exclusively to 6 months (5)), n=160 
women would be required to ensure n=41 at endline (6 months). However, women recruited for this 
study a) will be screened in to the study after they’ve reached peak milk production (23), b) will have 
had previous success breastfeeding to 6 months, and c) understand the study design and are 

Responsive Feeding of Infants with Expressed Milk (REFINE) study: Protocol 
 
Page 11 of 20 
volunteering to follow this study protocol. As such, we anticipate we will retain two thirds of 
participants after screening into this study, so will aim to recruit 62 dyads. 
 
7. Recruitment and Eligibility 
 
7.1 Recruitment 
 
We will recruit 62 mother-infant dyads <6 weeks postnatal via convenience sampling (over 18 
months; timeline below). We will engage with families in the early postnatal period through 
advertisements delivered via social media, and posters/pamphlets distributed via doctors offices, Le 
Leche League meetings, and local community centres and day care centers. Mothers who express an 
interest in participating will be contacted via phone to undergo intensive screening to provide more 
information about the study, including what is involved, potential risks (e.g. maintaining milk supply, 
nipple confusion) and benefits, and review eligibility criteria. Once participants are enrolled we will 
schedule a training session at 5 weeks postpartum in preparation for the in-home weighing during 
week 6. 
 
7.2 Eligibility criteria 
 
Mother-infant dyads are eligible to participate if: 
• 
mothers are aged 19 years or older, 
• 
dyads currently live in the Halifax Regional Municipality in Nova Scotia, 
• 
mothers have no chronic diseases, 
• 
the baby is a healthy singleton baby who is younger than 6 weeks of age, and is fed 
mother’s milk directly from the breast and from a bottle, 
• 
mothers plan to exclusively feed their baby mother’s milk up to 6 months, 
• 
mothers have an older child whom they successfully fed mother’s milk for a 
minimum of 6 months,  
• 
mothers are willing to participate in three 3-day study sessions and monthly 
measurement sessions, and 
• 
mothers provide informed consent for herself and her infant to participate. 
 
Mother-infant dyads are ineligible to participate if: 
• 
the baby was born preterm (earlier than 37 weeks gestation),  
• 
the baby was born outside the healthy weight range of 2,500 – 4,000 g (5lb 8oz to 8lb 
13oz),  
• 
the baby has a developmental delay diagnosed before the time of enrolment, 
• 
the baby is currently receiving any medical treatment except for vitamin D 
supplementation (no more than 400 IU/day), 
• 
the mother sought prescription medical treatment for lactation (e.g. domperidone, 
antibiotics, prescription nipple ointment), or 
• 
the mother plans to move in the 6 months after starting the study. 
 
 

Responsive Feeding of Infants with Expressed Milk (REFINE) study: Protocol 
 
Page 12 of 20 
 
7.3 Participant withdrawal 
 
Participants are free to withdraw from the study at any time without consequence. Participants who 
withdraw from the study will not be replaced. Any data collected on that participant up to the time 
of withdrawal will be retained for analysis.  
 
8. Study Procedures 
 
At each timepoint (6 weeks, 4 months, 6 months) infants will: be randomized using a balanced 
design (to control for order effect) to consume HM from a bottle or from the breast for 24 hours; 
will then undergo a wash-out period in which they will be fed HM as they usually would for 24 hours; 
then will complete the second ‘treatment’ (bottle or breast) for 24 hours (see Figure 2). Due to the 
nature of the intervention, this study will not be blinded. The study will be scheduled from the 
Tuesday through Thursday during the week the infant reaches 6 weeks, 4 months, and 6 months of 
age. Mid-week is ideal for data collection as the mother-infant dyads are most likely to be in their 
usual routine. Mothers will use their own feeding equipment (bottles, etc.) to ensure that both 
infants and mothers are comfortable with the equipment, and we collect data from the most realistic 
scenario. Mothers who typically hand express milk will be loaned a hospital-grade HM pump. 
 
8.1 Indirect weights 
 
Mothers will complete an indirect weigh twice at each feed within the 24 hour treatment phases to 
measure infant’s HM intake. Using a well-established method (24), mothers simply place their infant 
on the scale before the feed, then again after the feed is finished (without changing diapers or 
clothing between weighs). The volume of milk consumed for each feed is determined by calculating 
the weight change between the two weights, divided by the specific gravity of human milk (1.032 
g/mL) (24). During the data collection week, mothers will be loaned a Seca Infant Scale (Model 
727), which is accurate to 1 g, and uses direct wireless transmission of weight, limiting participant 
bias and burden. 
 
If infants consume more or less milk than usual in their first treatment, the 24 hour wash-out will 
allow infants to return to their baseline usual energy intake before the second treatment. Latin 
Square randomization will be employed to prevent order effect. 
 
Compliance to indirect weighs will be assessed via maternal self-report. We will provide mothers 
with 3 sheets with 24 slots, and will ask them to ‘tick off’ breast- and bottle-feeds during the 3-day 
intervention. From this, we will know whether the dyad maintained the intervention for the 24-hour 
feeding period (e.g. whether they actually feed only from the breast during the 24-hour breastfeeding 
‘treatment’), and can cross-compare this to the timestamps from the automatically assessed infant 
indirect weights (via Seca Infant Scale Model 727).  
 
8.2. Infant growth monitoring  
 
Infant anthropometric measurements (length, weight, head circumference) and growth rates (WAZ, 
LAZ, WLZ, BAZ) will be measured at baseline (6 weeks postnatal) and monthly from 2 – 6 months. 
Standard methodologies will be employed (25), and all measurements should take <5 minutes to 

Responsive Feeding of Infants with Expressed Milk (REFINE) study: Protocol 
 
Page 13 of 20 
complete. Mothers will be reminded via text message/call to drop by the MAMA Lab at the Centre 
for Applied Research in Human Health to have these measurements completed. Mothers will also 
be given the option of having a research assistant complete these measures in her home. 
 
8.3. Questionnaires  
 
Mothers will complete a self-administered questionnaire at baseline (6 weeks postnatal) and monthly 
from 2 – 6 months, to collect information on demographics, socioeconomic status, usual infant feeding 
practices and dietary intake (including introduction of complementary foods), infant feeding equipment 
(electronic breast pump, brand of bottles and nipples), and some limited maternal dietary 
intake/supplement/herbal product information. This questionnaire will also include the validated 
Household Food Insecurity Access Scale (26) and Intuitive Eating Scale-2 (IES-2) (27). 
 
8.4 Mothers’ height and body composition  
 
We will also measure mother’s height, and body composition (using BODPOD) during the monthly 
visits.  
 
8.5. Human milk samples 
 
We will collect milk samples from mothers during the monthly visits (samples will be stored in 
“BioBank”, MAMA Lab’s -80°C freezer, for future analysis). Milk samples will be collected using our 
Medela Hospital Grade pump, or, if mothers are more comfortable, their own pump. One full breast 
expression (single breast) will be collected from the breast women self-identify as being more ‘full’ (the 
breast not most recently emptied). Time of day, time since last meal, breast side, and milk volume 
(weight of milk to 1 g) will be recorded. We will aliquot 12 mL of sample (<1tbsp) immediately using 
sterile, one-time-use materials and store samples in the -80°C freezer, and return the rest of the milk to 
the mother to feed to the infant (or dispose of the rest of the milk if she prefers).  
 
8.6 Video recording  
 
We will invite a sub-set of participants to join in an additional data collection endeavour, video-
recording breast- and bottle-feeding sessions in their home. At each timepoint (6 weeks, 4 months, 6 
months) we will invite the same 30 participants to have their feeding sessions video-recorded to 
objectively assess and analyze responsiveness of infant feeding practices using the Nursing Child 
Assessment Satellite Training (NCAST) Caregiver/Parent-Child Interaction Feeding Scale (28).  
 
The researcher will set up three tripod-mounted video cameras in a room where ≥50% of infant 
feeds are typically conducted (e.g. living room or nursery): one camera will be focused on the 
infant’s face, one on the mother’s face, and one will be placed approximately 10-12 feet from the 
feeding dyad to capture the entire feed (29). We will provide the mother with a sign, which she will 
be asked to hold up immediately before the start of the feed, and immediately after the end of the 
feed, which will indicate the feeding session. Any video footage not within this feeding window will 
not be analyzed, and will be permanently deleted. This feeding session will be recorded as a digital 
media file. The researchers will step out of the room during the feeding session as not to interfere 
with the usual feeding practices.  

Responsive Feeding of Infants with Expressed Milk (REFINE) study: Protocol 
 
Page 14 of 20 
8.7 Interviews 
 
At two timepoints (t=6-8 weeks, and t=20-22 weeks) the same 20 mothers will be randomly invited 
to participate in open-ended semi-structured one-on-one interviews. These will be subsequently 
transcribed verbatim and thematically analyzed. 
 
8.8. Participant remuneration 
 
Participants will be compensated after each of the data collection points: $75 for each 3-day food 
intake measurement session (maximum of 3, =$225), $10 for each anthropometric measurement and 
milk collection session (maximum of 6, =$60), $20 for the video recording session (n=30 only; 
maximum of 3, =$60), and $20 for an interview (n=20 only; maximum of 2, =$40). Moreover, if 
they wish, we will provide mothers with all of their baby’s growth information and their body 
composition information (approx. $35 value per measurement). Free lactation consultant services 
will be made available to mothers who cite concern about breastfeeding, maintaining milk supply, or 
other related issues. 
 
9. Adverse Event Reporting 
 
As described in 2.6 Serious Adverse Events Committee / Data Safety Monitoring Board, there will be no 
Serious Adverse Events Committee or Data Safety Monitoring Board assembled for this study, 
because of the absence of potential adverse events from the study. The participants will be asked to 
feed their infants as they normally would. Inclusion criteria indicates that women already need to be 
actively expressing milk, so mothers and infants will be familiar with pumping and feeding with a 
bottle. No invasive data collection techniques will be used. The infants’ anthropometric measures 
will be collected using standard techniques. The feeding sessions will be video recorded in privacy of 
participant’s homes. The questionnaires and interview guides do not impose any possible harms 
greater than those encountered by participants in their everyday life.   
 
Since some of the data will be collected in participant’s homes, there is potential of unanticipated 
discoveries (e.g. spousal abuse). Since these would be incidental and the RAs, as well as PI are not 
experts in uncovering such information, they will inform the appropriate authorities. For example, if 
living conditions seem unsafe or there is risk/evidence of abuse, a report to the Halifax Regional 
Police will be filed as per https://www.halifax.ca/fire-police/police/programs-services/victim-
services-halifax/domestic-violence.  
 
10. Data analysis 
 
Quantitative data will be analysed in SPSS (descriptive and inferential statistics). The WHO Anthro 
plug-in for SPSS will be used to plot growth rates. Feeding responsiveness will be assessed using 
NCAST Parent-Child Interaction Feeding Scale. Qualitative data from interviews will be transcribed 
verbatim (e.g. Trint software with manual corrections) and thematically analyzed in MAXQDA. 
 
OBJ1. Within-dyad 24 hour intake of HM (g), by treatment (bottle versus breast), will be assessed by 
paired t-tests, for each timepoint (6 weeks, 4, and 6 months). We will also assess between-dyad 24 hour 
HM intake (g) (independent t-tests at each time point). Descriptive statistics will be computed: mean 
(SD) for continuous variables (maternal age, annual household income), or n (%) for categorical 

Responsive Feeding of Infants with Expressed Milk (REFINE) study: Protocol 
 
Page 15 of 20 
variables (maternal education, hedonic scale responses for usual infant feeding practices). We will also 
build general linear models to calculate estimated marginal means (95% CI) of HM intake by feeding 
modality, adjusted for potential confounders (maternal age, education, and socioeconomic status).  
 
OBJ2. Growth rates will be computed for each child using WHO Anthro plug-in for SPSS; we will 
assess each child for growth trajectory and percentile changes from baseline (6 weeks). Descriptive 
statistics will be computed for mother’s anthropometrics and body composition. Using categories of 
usual infant feeding modality (questionnaire from Objective 1; predominantly breastfed/predominately 
bottle-fed HM/equal mix feeding) we will compute and compare measures (length, weight, head 
circumference), percentiles for growth charts (WAZ, WLZ, LAZ, BAZ), and mother’s measures using 
one-way ANOVA (with least significant difference adjustment for multiple comparisons between usual 
feeding modality) at each time point.  
 
OBJ3. Videos will be analysed using the NCAST Parent-Child Interaction Feeding Scale, a 
standardized scale with published validity and reliability measures to assess observable behaviors that 
describe caregiver/parent child interactions (55). We will also compute correlations between 
NCAST infant responsive feeding and IES-2 maternal intuitive eating scores (27).  
 
OBJ4. Research assistants will conduct one-on-one interviews, and will transcribe transcripts verbatim 
(e.g. Trint software with manual corrections). Thematic analysis with inductive, open coding will be 
employed to allow patterns, codes, and categories to emerge from the data (MAXQDA software).  
  
11. Administrative Aspects, and Data Security and Management   
 
11.1 Obtaining informed consent 
 
Recruitment posters will advise interested parties to contact the research team via email. An RA will 
provide a copy of the consent form to the interested individual in advance of a telephone screening 
interview where the individual will be asked to confirm eligibility over the phone. They will then set 
up a date and time for an in-person meeting with the potential participant to go over the consent 
form in more detail (see Appendix). Interested individuals will be advised to ask questions and take 
time before they provide written, informed consent. The RA will make sure to emphasize that the 
participation in this study is completely voluntarily and that an individual can decide not to 
participate or to withdraw at any time without consequence.  
 
Note: mothers are the study participants. We will obtain consent from the mother, including 
permission for the infant to be involved with the study (e.g. to be fed as part of the study). 
 
11.2 Ethics 
 
Ethics approval has been obtained from the Research Ethics Boards of the following institutions: 
• Mount Saint Vincent University (#2018-155) 
• University of Prince Edward Island (#6008074) 
 
This research will be registered with clinicaltrials.gov. 
 
 

Responsive Feeding of Infants with Expressed Milk (REFINE) study: Protocol 
 
Page 16 of 20 
11.3 Confidentiality and data security 
 
Participants will be given a code unique to our study. A key linking the subject code to participant 
information will be kept on a password protected computer in a secure area in the office in the MAMA 
Lab at MSVU. There is no need for co- investigators elsewhere to have information linking participant 
names with their unique identifier.  
 
This unique identifier will not be derived from personal identifiers. All electronic data files will be stored 
on password protected tablets, computers and/or secure servers accessible only to members of the 
research team. Archived electronic data files and any hard copies of data, consent forms or other papers 
containing data will be stored in locked filing cabinets in locked research rooms at the MAMA Lab.  
 
All identifying information will be removed from the interview transcripts before data analysis. The only 
identifying information that cannot be removed are the faces and voices of the participants on the video-
recorded feeding sessions, since these are needed to be included in order to score the feeding interaction. 
However, once the videos are scored using adapted NCAST Parent-Child Interaction Feeding Scale, no 
identifying data will be entered into the database for analysis. 
 
All data will be saved for at least 5 years following the publication of research findings, at which point it 
will be permanently destroyed. Data regarding the primary objective of this randomized cross-over trial 
will be kept for 25 years. Electronic data will be permanently deleted from computers and hard drives 
using file-shredding software. Paper documents will be shredded. Milk samples will be stored for 5 years 
in -80°C freezers, then destroyed following biological safety protocols. During this time, only the PI 
will have access to these data/samples, and the PI will be responsible for destroying data/samples at 
the appropriate time. 
 
11.4 Modifications to the protocol 
 
This study will be conducted per the current version of the protocol. Any change to the protocol 
document or related study tools that affects the scientific intent, study design, or participant safety, 
or that may affect a participant’s willingness to continue participation in the study, will be considered 
an amendment, and therefore will be written and filed as such.   
 
11.5 Protocol deviations 
 
Protocol deviations will be documented and reported to the Principal Investigator if data collection 
for the primary outcome does not fall within ± 4 days at Week 6, or ± 7 days at Months 4 and 6, of 
the specified data collection date.  
 
11.6 Study closure 
 
The Principal Investigator (or designee) may terminate the study prematurely if data become 
available which raise concern about the safety of the study treatment(s) that have potential to cause 
unacceptable risks to subjects. If premature study closure occurs, the Principal Investigator (or 
designee) will contact all participants within two weeks, and written notification must be sent to the 
Ethics Committees, study funder, and trial registry.  
 

Responsive Feeding of Infants with Expressed Milk (REFINE) study: Protocol 
 
Page 17 of 20 
12. Use of Data, and Dissemination 
 
12.1 Academic dissemination 
 
Results of this study will be presented at academic nutrition, public health, and lactation conferences 
(i.e. Canadian Nutrition Society Annual Meeting, International Society for Research in Human Milk 
and Lactation Conference), in peer-reviewed, academic journals, as well as through Master’s Theses. 
Authorship will be determined based on the International Committee of Medical Journal Editors 
Authorship Guidelines. There is no plan to use professional writers for dissemination.  
 
12.2 Layperson dissemination 
 
We will create various lay outputs from this study that can be used as teaching resources by 
healthcare providers working with families, or can be accessed directly by families. These may 
include short video clips, infographics, or ‘hot tips,’ which we will make available online and (if 
applicable) in print for distribution at local agencies (public health, in hospitals, community centers, 
etc). We will host a Dissemination Workshop open to the public (families, media, clinicians, public 
health, all sectors) to share the main outcomes of the study, and to officially ‘launch’ resources 
online.   
 

Responsive Feeding of Infants with Expressed Milk (REFINE) study: Protocol 
 
Page 18 of 20 
13. References  
 
1.  
Victora CG, Bahl R, Barros AJD, Franca GVA, Horton S, Krasevec J, Murch S, Sankar MJ, 
Walker N, Rollins NC. Breastfeeding in the 21st century: epidemiology, mechanisms, and 
lifelong effect. Lancet. Elsevier Ltd; 2016;387:475–90.  
2.  
Kramer MS, Kakuma R. The optimal duration of exclusive breastfeeding: a systematic review. 
World Health Organization. Switzerland; 2002.  
3.  
Van De Perre P. Transfer of antibody via mother’s milk. Vaccine. 2003;21:3374–6.  
4.  
Lamberti LM, Fischer Walker CL, Noiman A, Victora C, Black RE. Breastfeeding and the 
risk for diarrhea morbidity and mortality. BMC Public Health. BioMed Central Ltd; 
2011;11:S15.  
5.  
Gionet L. Breastfeeding trends in Canada [Internet]. Ottawa, Canada; 2013. Available from: 
http://www.statcan.gc.ca/pub/82-624-x/2013001/article/11879-eng.htm 
6.  
Felice JP, Cassano PA, Rasmussen KM. Pumping human milk in the early postpartum period: 
its impact on long-term practices for feeding at the breast and exclusively feeding human milk 
in a longitudinal survey cohort. Am J Clin Nutr. 2016;103:1267–77.  
7.  
West JM, Power J, Hayward K, Joy P. An exploratory thematic analysis of the breastfeeding 
experience of students at a Canadian university. J Hum Lact. 2017;33:205–13.  
8.  
Howard CR, Howard FM, Lanphear B, Eberly S, DeBlieck EA, Oakes D, Lawrence RA. 
Randomized clinical trial of pacifier use and bottle-feeding or cupfeeding and their effect on 
breastfeeding. Pediatrics. 2003;111:511–8.  
9.  
Viggiano D, Fasano D, Monaco G, Strohmenger L. Breast feeding, bottle feeding, and non-
nutritive sucking; effects on occlusion in deciduous dentition. Arch Dis Child. 2004;89:1121–
3.  
10.  
Li R, Fein SB, Grummer-Strawn L. Association of breastfeeding intensity and bottle-
emptying behaviors at early infancy with infants’ risk for excess weight at late infancy. 
Pediatrics. 2008;122:S77–84.  
11.  
Bartok CJ, Ventura AK. Mechanisms underlying the association between breastfeeding and 
obesity. Int J Pediatr Obes. 2009;4:196–204.  
12.  
Golen RB, Ventura AK. Mindless feeding: is maternal distraction during bottle-feeding 
associated with overfeeding? Appetite. Elsevier Ltd; 2015;91:385–92.  
13.  
Brown A, Lee M. Breastfeeding during the first year promotes satiety responsiveness in 
children aged 18-24 months. Pediatr Obes. 2012;7:382–90.  
14.  
World Health Organization. World Health Organization Infant Feeding Recommendation 
[Internet]. Geneva, Switzerland; 2017. Available from: 
http://www.who.int/nutrition/topics/infantfeeding_recommendation/en/ 
15.  
Dewey KG. Growth characteristics of breast-fed compared to formula-fed infants. Biol 
Neonate. 1998;74:94–105.  
16.  
Dewey KG. Is breastfeeding protective against child obesity? J Hum Lact. 2003;19:9–18.  
17.  
Heinig MJ, Nommsen LA, Peerson JM, Lonnerdal B, Dewey KG. Energy and protein intakes 
of breast-fed and formula-fed infants during the first year of life and their association with 
growth velocity: the DARLING study. Am J Clin Nutr. 1993;58:152–61.  
18.  
Ventura AK, Inamdar LB, Mennella JA. Consistency in infants’ behavioural signalling of 
satiation during bottle-feeding. Pediatr Obes. 2015;10:180–7.  
19.  
Li R, Scanlon K, May A, Rose C, Birch L. Bottle-feeding practices during early infancy and 
eating behaviors at 6 years of age. Pediatrics. 2014;134:S70–7.  
20.  
Ventura AK, Golen RP. A pilot study comparing opaque, weighted bottles with conventional, 
clear bottles for infant feeding. Appetite. 2015;85:178–84.  

Responsive Feeding of Infants with Expressed Milk (REFINE) study: Protocol 
 
Page 19 of 20 
21.  
Wood CT, Skinner AC, Yin HS, Rothman RL, Sanders LM, Delamater A, Ravanbakht SN, 
Perrin EM. Association between bottle size and formula intake in 2-month-old infants. Acad 
Pediatr. Elsevier Inc; 2016;16:254–9.  
22.  
Golen RP, Ventura AK. What are mothers doing while feeding their infants? Exploring the 
prevalence of maternal distraction during infant feeding interactions. Early Hum Dev. 
2015;91:787–91.  
23.  
Hill PD, Aldag JC, Chatterton RT, Zinaman M. Comparison of milk output between mothers 
of preterm and term infants: the first 6 weeks after birth. J Hum Lact. 2005;21:22–30.  
24.  
Miller EM, Aiello MO, Fujita M, Hinde K, Milligan L, Quinn EA. Field and laboratory 
methods in human milk research. Am J Hum Biol. 2013;25:1–11.  
25.  
Cogill B. Anthropometric Indicators Measurement Guide. Washington, DC; 2003.  
26.  
Coates J, Swindale A, Bilinsky P. Household Food Insecurity Access Scale (HFIAS) for 
Measurement of Food Access: Indicator Guide (v. 3). Washington, DC; 2007.  
27.  
Tylka TL, Kroon Van Diest AM. The Intuitive Eating Scale-2: item refinement and 
psychometric evaluation with college women and men. J Couns Psychol. 2013;60:137–53.  
28.  
Oxford ML, Findlay DM (Eds. . NCAST Caregiver/Parent-Child Interaction Feeding Manual 
(2nd ed.). Seattle: NCAST Programs, University of Washington, School of Nursing; 2015.  
29.  
Whitfield KC, Ventura AK. Exploration of responsive feeding during breastfeeding versus 
bottle feeding of human milk: a within-subject pilot study. Breastfeed Med [Internet]. 2019;In 
Press. Available from: https://www.liebertpub.com/doi/10.1089/bfm.2019.0069 
 
  
 
 
 
 
 
 
 
 

Responsive Feeding of Infants with Expressed Milk (REFINE) study: Protocol 
 
Page 20 of 20 
Appendix: Consent forms (see next 13 pages). 
 

REFINE Study  
 
Consent Form: General 
 
 
Page 1 of 5 
Version 4.1. September 27, 2019 
  
 
  
 
 
REFINE STUDY 
CONSENT FORM 
 
Introduction 
 
We invite you to take part in the research study called Responsive Feeding of Infants with Expressed Milk 
(REFINE Study) This form gives information about the study. Before you decide if you want to participate, 
it is important that you understand the purpose of the study, what you will be asked to do, and the risks and 
benefits. We will explain all information before asking for your consent to participate. A member of the 
research team will be available to answer any questions. You may decide not to participate. You may also 
withdraw from the study at any time without any problems. Your participation is entirely voluntary. 
 
Who is conducting the study? 
 
Dr. Kyly Whitfield, Principal Investigator, Assistant Professor 
Department of Applied Human Nutrition, Mount Saint Vincent University 
Phone: (902) 457-5978. E-mail: kyly.whitfield@msvu.ca 
 
Dr. Misty Rossiter, Co-Investigator, Associate Professor  
Department of Applied Human Sciences, University of Prince Edward Island 
Phone: (902) 620-5224. E-mail: mdrossiter@upei.ca 
  
Dr. Jennifer Brady, Co-Investigator, Assistant Professor  
Department of Applied Human Nutrition, Mount Saint Vincent University 
Phone: (902) 457-6260. Email: jennifer.brady@msvu.ca  
 
Dr. Erna Snelgrove-Clarke, RN, PhD 
Co-Investigator, Vice Dean (Health Sciences), Director, School of Nursing  
Faculty of Health Sciences, Queen's University   
Kingston, Ontario, Canada 
Phone: (613) 533-2669. Email: erna.snelgroveclarke@queensu.ca  
 
This study is funded by Nova Scotia Health Research Foundation. This study is registered on 
clinicaltrials.gov with an identifier NCT04041505. The researchers have no conflicts of interest to report.  
 
What is the study about? 
 
Breastfeeding has health benefits for both mothers and babies. Mother’s milk is the best food for babies. 
How babies eat this milk is changing as pumping becomes more popular. Health professionals long thought 
that feeding a bottle of pumped breastmilk was the same as breastfeeding. Yet, there is research showing 
that how the baby is getting mother’s milk is also important. It may have long-term impacts, for instance on 
baby’s ability to understand if s/he is hungry or full.  

REFINE Study  
 
Consent Form: General 
 
 
Page 2 of 5 
Version 4.1. September 27, 2019 
 
We plan to invite 62 mother-infant pairs in the Halifax Regional Municipality to participate in this study. We 
will follow babies eating mother’s milk from both the breast and a bottle from 6 weeks to 6 months. We aim 
to better understand how infants eat, grow and interact with caregivers during feeding.  
 
Who can participate? 
 
You will chat with a member of the research team to determine if you can participate in this study.  
 
You may be eligible to participate if you: 
• 
are 19 years or older, 
• 
currently live in the Halifax Regional Municipality in Nova Scotia, 
• 
have no chronic diseases, 
• 
have a healthy singleton baby who is younger than 6 weeks of age who is fed mother’s milk 
directly from the breast and from a bottle, 
• 
plan to exclusively feed your baby mother’s milk up to 6 months, 
• 
have an older child whom you successfully fed mother’s milk for a minimum of 6 months, 
and 
• 
are willing to participate in three 3-day study sessions and monthly measurement sessions. 
You are not eligible to participate if: 
• 
your baby was born preterm (earlier than 37 weeks gestation),  
• 
your baby was born outside the healthy weight range of 2,500 – 4,000 g (5lb 8oz – 8lb,13oz), 
• 
your baby has a diagnosed developmental delay diagnosed before the time of enrollment, 
• 
your baby is currently receiving any medical treatment, except for vitamin D 
supplementation (no more than 400 IU/day), 
• 
you sought prescription medical treatment for lactation (e.g. domperidone, antibiotics, 
prescription nipple ointment), or 
• 
you plan to move in the next 6 months. 
Taking part in this study is completely voluntary. You do not need to answer any questions that you don’t 
feel comfortable answering. You may choose not to take part or may leave the study at any time. You do 
not have to give a reason for your decision. 
 
What will participation in this study look like? 
 
Questionnaires 
The study will begin when your baby is 6 weeks old and finish when your baby is 6 months old. After you 
sign this consent form, we will ask you to complete a questionnaire. It will ask questions about yourself 
(such as your age, ethnicity, diet, and eating attitudes and behaviours), and about your baby (such as details 
of the delivery, and how you usually feed your baby). It will likely take you about 30 minutes to fill out. We 
will then ask you to fill out a shorter questionnaire each month from 2 to 6 months. Each of these 
questionnaires is likely to take about 10 minutes to fill out. 
 
Milk intake 
At three time points (when your baby is 6 weeks, 4 months, and 6 months old) you will set up an 

REFINE Study  
 
Consent Form: General 
 
 
Page 3 of 5 
Version 4.1. September 27, 2019 
appointment with a research team member. She or he will come to your home to help set up equipment for 
a 3-day feeding session. We will ask you to follow specific instructions for 3 days, usually from Tuesday 
through Thursday. We will ask you to feed your baby only from the breast for the first day, as usual (breast 
and bottle) for the second day, and from a bottle for the third day (or the other way around: bottle-usual-
breast). During the first and third day we will ask you to weigh your baby before and after each feeding. We 
will give you a scale and train you how to use it. Members of the research team will be available by phone 
from 8 am to 10 pm daily to answer any questions.  
 
Growth and body composition, and milk samples 
Each month we will measure your baby’s growth: weight, length, and head circumference (~7 minutes). We 
will also measure your body composition using a BODPOD (~15 minutes, 3 minutes inside BODPOD). 
The BODPOD is a device that uses changing air pressure to calculate fat and lean body mass. Ideally you 
will come to MSVU with your baby so that we can conduct all measures. The other option is for a research 
team member to come to your home to measure your baby’s growth.  
 
During these visits we will also ask you to give a milk sample. This is optional, and we will ask you to 
provide separate consent at the end of this consent form. You can use the hospital grade pump in our 
research centre. The other option is for you to use your own pump if you’re more comfortable with it. 
These milk samples will be identified only with your Study ID. The samples will be stored in our -80°C 
freezer for future analysis for nutrient content and other compounds such as bioactives and hormones. 
 
Caregiver-infant feeding behaviours  
We will randomly invite some of the mothers to participate in a video-recorded feeding sessions. If you’re 
selected and invited to participate, we will give you a separate consent form. This part is additional and it is 
not required for your participation in the study.  
 
Understanding infant feeding in Nova Scotia 
We will randomly invite some of the mothers to participate in a one-on-one interview about infant feeding.  
If you’re selected and invited to participate, we will give you a separate consent form. This part is additional 
and it is not required for your participation in the study.  
 
Participation in this study is entirely voluntary. It will not cost you anything. As a thank you for your time, 
we will provide the following: $75 for each 3-day milk intake session (6 weeks, 4 months, and 6 months), 
$10 for each growth measurement session. We will also give you all of your baby’s growth information and 
your body composition information (approx. $35 value per measurement). You will receive compensation 
after each of the data collection sessions. If you decide to withdraw the during one of the data collection 
points, you will still receive compensation for that session. If you have any difficulties with breastfeeding as 
a result of participation in this study, we will arrange an appointment with a lactation consultant free of 
charge.  
 
Confidentiality 
 
Your confidentiality will be respected. Your records will be kept in a locked cabinet in the Milk and 
Micronutrient Assessment Lab (MAMA Lab) at Mount Saint Vincent University. All electronic data will be 
stored on a university-based, password protected server. We will give you a unique study number as a 
participant in this study. Only this number will be used on any research-related information collected about 
you during the course of this study. Your identity [i.e. your name or any other information that could 

REFINE Study  
 
Consent Form: General 
 
 
Page 4 of 5 
Version 4.1. September 27, 2019 
identify you] will be kept confidential. Only Principal Investigator will have access to any data that contains 
your personal information (such as this consent form). The list that matches your name to the unique study 
number will not be removed or released. 
 
Only the research team will view and analyze the information gathered as part of this study. The results of 
the study may be presented at scientific meetings, published in a scientific journal and used for Master’s 
Theses. If the results are published, only group values will be reported. Pseudonyms will be used if your 
interview responses are quoted. All data will be kept on a locked database for 25 years and then securely 
destroyed. 
 
Please note that data will be kept confidential within the confines of the law. For instance, if we come across 
an evidence of abuse in a course of this study, we are obligated to report it to appropriate authorities, such 
as Halifax Regional Police.  
 
Risks 
 
We do not believe there are any risks involved with participation in this study. 
 
Benefits 
 
You will receive your baby’s growth information and your body composition data as a participant of this 
study. You will have the benefit of contributing to research. We hope that the results of this study can be 
used to inform future research, public policy and education programs about the feeding of young children. 
 
Questions and further information 
 
Participation in this study is completely voluntary. Also, you have the option to stop participating and 
withdraw from the study at any time without any problems. 
 
If you have any questions or would like further information about this research, please contact Dr. Kyly 
Whitfield, the Principal Investigator, at kyly.whitfield@msvu.ca, or by phone at (902) 457-5978.  
 
If you have questions about how this study is being conducted and wish to speak with someone who is not 
directly involved in the study, you may contact the MSVU Research Office at (902) 457-6350 or via e-mail at 
research@msvu.ca.  
 
You can also contact the UPEI Research Ethics Board at (902) 620-5104, or by email at reb@upei.ca if you 
have any concerns about the ethical conduct of this study. 
 
Research Results 
 
A summary of research results will be made available online at mamalab.ca. The ethical components of this 
research study have been reviewed by the Research Ethics Boards at Mount Saint Vincent University and 
the University of Prince Edward Island. 
 

REFINE Study  
 
Consent Form: General 
 
 
Page 5 of 5 
Version 4.1. September 27, 2019 
 
  
 
 
Consent Form for Research Participation 
 
PARTICIPANT AUTHORIZATION: 
I have read or had read to me this information and authorization form. I have had the chance to ask 
questions. My questions have been answered to my satisfaction before moving forward. I understand the 
nature of the study. I also understand the potential risks. I understand that I have the right to withdraw 
from the study at any time without any problems. I have received a copy of the Consent Form for future 
reference.  
I freely agree to participate in this research study. 
       YES                      NO 
 
OPTINAL FOLLOW-UP 
We would like to keep your contact information in case there are opportunities to follow-up with you and 
your child for future research. For example, we could contact you asking if you would like your child to use 
the BODPOD after they reach 2 years. There is no obligation to agree to future research participation now. 
We are simply asking to keep your phone number and email address in a locked database for potential 
future use. This is in no way required for participation in the current study.  
I agree to allow the research team to contact me in the future about other research participation 
opportunities.  
       YES                      NO 
 
OPTIONAL MILK SAMPLE 
We would like to collect milk samples, identified only with your Study ID. These will be stored in our -80°C 
freezer for future analysis for nutrient content and other compounds such as bioactives and hormones. 
I agree to provide milk samples to be entered into a Milk BioBank at MSVU for future analysis. 
       YES                      NO 
 
 
Print name of Participant: ________________________________________________  
Date: _______________________  Signature: _______________________________________________ 
____________________________________________________________________________________ 
 
STATEMENT BY PERSON PROVIDING INFORMATION ON STUDY AND OBTAINING CONSENT 
I have explained the nature and demands of the research study and judge that the participant named above understands the 
nature and demands of the study. I have explained the nature of the consent process to the participant and judge that they 
understand that participation is voluntary and that they may withdraw at any time from participating. 
 
Print name of Person Explaining Consent: ________________________________________ 
Date: _______________________   Signature: ______________________________________________ 

REFINE Study  
 
Consent Form: Video-Recording 
Page 1 of 4 
Version 3.1. September 27, 2019.  
 
  
 
 
REFINE STUDY 
CONSENT FORM FOR VIDEO RECORDING FEEDING SESSION 
 
Introduction 
This is a consent form specific to the video-recorded feeding session as part of the larger study called 
Responsive Feeding of Infants with Expressed Milk (REFINE Study).This form will provide information 
specifically about the video-recording portion of the study. Before you decide if you want to participate, it is 
important that you understand the purpose of the study, what you will be asked to do, and the risks and 
benefits. We will give you all of this information before asking for your consent to participate. A member of 
the research team will be available to answer any questions. You may decide not to participate. You may also 
withdraw from the study at any time without any problems. Your participation is entirely voluntary. 
 
Who is conducting the study? 
Dr. Kyly Whitfield, Principal Investigator, Assistant Professor 
Department of Applied Human Nutrition, Mount Saint Vincent University 
Phone: (902) 457-5978. E-mail: kyly.whitfield@msvu.ca 
 
Dr. Misty Rossiter, Co-Investigator, Associate Professor  
Department of Applied Human Sciences, University of Prince Edward Island 
Phone: (902) 620-5224. E-mail: mdrossiter@upei.ca  
 
Dr. Jennifer Brady, Co-Investigator, Assistant Professor  
Department of Applied Human Nutrition, Mount Saint Vincent University 
Phone: (902) 457-6260. Email: jennifer.brady@msvu.ca  
 
Dr. Erna Snelgrove-Clarke, RN, PhD 
Co-Investigator, Vice Dean (Health Sciences), Director, School of Nursing  
Faculty of Health Sciences, Queen's University   
Kingston, Ontario, Canada 
Phone: (613) 533-2669. Email: erna.snelgroveclarke@queensu.ca  
 
This study is funded by Nova Scotia Health Research Foundation. The researchers have no conflicts of 
interest to report.  
 
What is the study about? 
Breastfeeding has health benefits for both mothers and babies. Mother’s milk is the best food for babies. 
How babies eat this milk is changing as pumping becomes more popular. Health professionals long thought 
that feeding a bottle of pumped breastmilk was the same as breastfeeding. Yet, there is research showing 
that how baby is getting mother’s milk is also important. It may have long-term impacts, for instance on 
baby’s ability to understand if she/he is hungry or full.  
 
Watching the interaction between infants and mothers during feeding can be very informative. It can 

REFINE Study  
 
Consent Form: Video-Recording 
Page 2 of 4 
Version 3.1. September 27, 2019.  
provide insight into the “how” of feeding. Researchers can watch video-recorded feeding sessions, and 
objectively score interactions using a validated tool. It is called the NCAST Parent-Child Interaction Feeding 
Scale. However, most researchers film feeding sessions in a laboratory, where interactions are usually not 
“normal”. We want to capture interactions in your own home, where you are used to feeding your baby.  
 
We are randomly inviting 30 participants from the overall study to participate in the video-recording 
sessions.  
 
Who can participate? 
Mothers already participating in the larger study are eligible to participate.  
 
Taking part in this study is completely voluntary. You may choose not to take part or may leave the study at 
any time during the data collection. You do not have to give a reason for your decision. 
 
What will participation in this study look like? 
At each timepoint (6 weeks, 4 and 6 months), we will video-record one breastfeeding and one bottle-feeding 
session. These feeding sessions will be video-recorded using small video cameras in the space where you 
usually feed your baby. The research assistant will set up 3 video cameras, start the recording, and leave the 
room. We will give you a paper sign and ask you to hold it up before starting the feed and immediately after 
ending the feed. Please feed your baby the way you normally do. We will delete any video footage not within 
this window without viewing. 
 
We will transport the videos on the memory card with the video camera back to the laboratory. We will then 
export the files to the password-protected folder and permanently delete them from the memory card. All 
electronic files will be stored in a password protected folder and on an external hard drive in a locked 
drawer in a locked office. In all cases, files will be password protected. The files will be kept for a minimum 
of five years and then securely destroyed. 
 
Participation in this study is entirely voluntary. It will not cost you anything. As a thank you for your time 
and participation, you will receive $20 for each video recording. 
 
If you wish to withdraw from this sub-study at the time of video recording, the videos will be permanently 
deleted without viewing. You will receive compensation. If you decide to withdraw after the research 
assistant has already picked up the videos and added them to the study dataset, the videos will be kept for 
analysis. 
 
Confidentiality 
Your confidentiality will be respected. Your records will be kept in a locked cabinet in the Milk and 
Micronutrient Assessment Lab (MAMA Lab) at Mount Saint Vincent University. All electronic data will be 
stored on a university-based, password protected server. We will give you a unique study number as a 
participant in this study. Only this number will be used on any research-related information collected about 
you during the course of this study. Your identity [i.e. your name or any other information that could 
identify you] will be kept confidential. Only Principal Investigator will have access to any data that contains 
your personal information (such as this consent form). The list that matches your name to the unique study 
number will not be removed or released. 
 
Only the research team will view and analyze the information gathered as part of this study. The results of 
the study may be presented at scientific meetings, published in a scientific journal and used for Master’s 

REFINE Study  
 
Consent Form: Video-Recording 
Page 3 of 4 
Version 3.1. September 27, 2019.  
Theses. If the results are published, only group values will be reported. Pseudonyms will be used if your 
interview responses are quoted. All data will be kept on a locked database for 5 years and then securely 
destroyed. 
 
Please note that data will be kept confidential within the confines of the law. For instance, if we come across 
an evidence of abuse in a course of this study, we are obligated to report it to appropriate authorities, such 
as Halifax Regional Police.  
 
Option to use your videos for educational purposes 
For the purposes of this research project, all videos will be viewed by the research team only. However, 
some mothers may choose to provide permission for these videos to be used for educational purposes, such 
as showing clips of the videos in relevant university classes to teach students about infant feeding, or for the 
production of a future educational movie clip. For example, nutrition students may need to explain good 
feeding behaviours in their future careers; if we capture you interacting with your baby in a positive way, it 
could be a terrific, and highly memorable, teaching tool to help these students remember this positive 
behaviour. Note that this is a possible secondary use of the video recordings and is in no way 
required for your participation in this study. If you would like to provide this permission to use these 
videos, please indicate this on the last page of this consent form. 
 
Risks 
We do not believe there are any risks involved with participation in this study. 
 
Benefits 
You will receive your baby’s growth information and your body composition data as a participant of this 
study. You will have the benefit of contributing to research. We hope that the results of this study can be 
used to inform future research, public policy and education programs about the feeding of young children. 
If you would like, we will provide you with a copy of the feeding session videos. 
 
Questions and further information 
Participation in this study is completely voluntary. Also, you have the option to stop participating and 
withdraw from the study at any time without any problems. 
 
If you have any questions or would like further information about this research, please contact Dr. Kyly 
Whitfield, the Principal Investigator, at kyly.whitfield@msvu.ca, or by phone at (902) 457-5978.  
 
If you have questions about how this study is being conducted and wish to speak with someone who is not 
directly involved in the study, you may contact the MSVU Research Office at (902) 457-6350 or via e-mail at 
research@msvu.ca.  
 
You can also contact the UPEI Research Ethics Board at (902) 620-5104, or by email at reb@upei.ca if you 
have any concerns about the ethical conduct of this study. 
 
Research Results 
A summary of research results will be made available online at mamalab.ca. The ethical components of this 
research study have been reviewed by the Research Ethics Boards at Mount Saint Vincent University and 
the University of Prince Edward Island.  
 

REFINE Study  
 
Consent Form: Video-Recording 
Page 4 of 4 
Version 3.1. September 27, 2019.  
 
 
  
 
 
Consent Form for Research Participation 
 
PARTICIPANT AUTHORIZATION 
I have read or had read to me this information and authorization form. I have had the chance to ask 
questions. My questions have been answered to my satisfaction before moving forward. I understand the 
nature of the study. I also understand the potential risks. I understand that I have the right to withdraw 
from the study at any time without any problems. I have received a copy of the Consent Form for future 
reference.  
I freely agree to participate in this research study and agree for myself and my baby to be video-
recorded. 
       YES                      NO 
 
OPTIONAL – USE OF VIDEOS FOR EDUCATION PURPOSES  
Do you provide permission for the video-recordings of you and your baby to be repurposed for educational 
purposes (e.g. viewing in university classes, for the production of an educational video, etc) after the 
research study is complete?  
       YES                      NO 
 
 
 
Print name of Participant: ________________________________________________  
Date: _______________________  Signature:_______________________________________________ 
 
 
 
 
 
 
 
 
 
____________________________________________________________________________________ 
STATEMENT BY PERSON PROVIDING INFORMATION ON STUDY AND OBTAINING CONSENT 
I have explained the nature and demands of the research study and judge that the participant named above understands the nature 
and demands of the study. I have explained the nature of the consent process to the participant and judge that they understand 
that participation is voluntary and that they may withdraw at any time from participating. 
 
Print name of Person Explaining Consent: ________________________________________________ 
Date: _______________________   Signature: _____________________________________________ 

REFINE Study 
 
Consent Form: Interviews 
Page 1 of 4 
Version 3.1. September 27, 2019. 
 
  
 
 
REFINE STUDY 
CONSENT FORM FOR ONE-ON-ONE INTERVIEW 
 
Introduction 
This is a consent form specific to the one-on-one interview regarding infant feeding. This is as part of the 
larger study called Responsive Feeding of Infants with Expressed Milk (REFINE Study). This form will give 
information about the one-on-one interview portion of the study. Before you decide if you want to 
participate, it is important that you understand the purpose of the study, what you will be asked to do, and 
the risks and benefits. We will give you all of this information before asking for your consent to participate. 
A member of the research team will be available to answer any questions you may have. You may decide not 
to participate. You may also withdraw from the study at any time without any problems. Your participation 
is entirely voluntary. 
 
Who is conducting the study? 
Dr. Kyly Whitfield, Principal Investigator, Assistant Professor 
Department of Applied Human Nutrition, Mount Saint Vincent University 
Phone: (902) 457-5978. E-mail: kyly.whitfield@msvu.ca 
 
Dr. Misty Rossiter, Co-Investigator, Associate Professor  
Department of Applied Human Sciences, University of Prince Edward Island 
Phone: (902) 620-5224. E-mail: mdrossiter@upei.ca 
  
Dr. Jennifer Brady, Co-Investigator, Assistant Professor  
Department of Applied Human Nutrition, Mount Saint Vincent University 
Phone: (902) 457-6260. Email: jennifer.brady@msvu.ca  
 
Dr. Erna Snelgrove-Clarke, RN, PhD 
Co-Investigator, Vice Dean (Health Sciences), Director, School of Nursing  
Faculty of Health Sciences, Queen's University   
Kingston, Ontario, Canada 
Phone: (613) 533-2669. Email: erna.snelgroveclarke@queensu.ca  
 
This study is funded by Nova Scotia Health Research Foundation. The researchers have no conflicts of 
interest to report.  
 
What is the study about? 
 
It is known that breastfeeding is the best way to feed babies for the first 6 months. Yet, there isn’t as much 
research on how or why mother’s milk is fed to Canadian infants. We want to hear from mothers about things 
such as why you pump milk, how you store and feed it to your baby. We will also ask about your 
perceptions and experiences feeding your infant, if or where you got information or advice about infant 
feeding, and about whether you’ve ever experienced stigma regarding how you’ve fed your baby.  

REFINE Study 
 
Consent Form: Interviews 
Page 2 of 4 
Version 3.1. September 27, 2019. 
 
We are randomly inviting 20 participants from the overall study for these in-depth one-on-one interviews.  
 
Who can participate? 
 
Every mother already enrolled in the larger study is eligible to participate in these interviews. Taking part in 
this study is completely voluntary. You may choose not to take part or may leave the study at any time. You 
do not have to give a reason for your decision. 
 
What will participation in this study look like? 
 
You will be asked to come to Mount Saint Vincent University, or the researcher will come to your home for 
the interview. The interviews will take about 1-1.5 hours and will be audio recorded. We will transcribe the 
interview verbatim, but will replace any names you use with pseudonyms.  
 
We will ask to do a second interview with you when your baby is between 20-22 weeks old. 
 
Participation in this study is entirely voluntary and will not cost you anything. As a thank you for your time 
and participation, you will receive $20 at the end of each visit. If you decide to withdraw from the study 
during an interview, you will still receive compensation. In this case, the audio recording of your interview 
will be destroyed.  
 
Confidentiality 
 
Your confidentiality will be respected. Your records will be kept in a locked cabinet in the Milk and 
Micronutrient Assessment Lab (MAMA Lab) at Mount Saint Vincent University. All electronic data will be 
stored on a university-based, password protected server. We will give you a unique study number as a 
participant in this study. Only this number will be used on any research-related information collected about 
you during the course of this study. Your identity [i.e. your name or any other information that could 
identify you] will be kept confidential. Only Principal Investigator will have access to any data that contains 
your personal information (such as this consent form). The list that matches your name to the unique study 
number will not be removed or released. 
 
Only the research team will view and analyze the information gathered as part of this study. The results of 
the study may be presented at scientific meetings, published in a scientific journal and used for Master’s 
Theses. If the results are published, only group values will be reported. Pseudonyms will be used if your 
interview responses are quoted. All data will be kept on a locked database for 25 years and then securely 
destroyed. 
 
Please note that data will be kept confidential within the confines of the law. For instance, if we come across 
an evidence of abuse in a course of this study, we are obligated to report it to appropriate authorities, such 
as Halifax Regional Police.  
 
Risks 
 
We do not believe there are any risks involved with participation in this study. 
 

REFINE Study 
 
Consent Form: Interviews 
Page 3 of 4 
Version 3.1. September 27, 2019. 
Benefits 
 
You will not receive direct benefits from participating in this study. You will have the benefit of 
contributing to research. We hope that the results of this study can be used to inform future research, public 
policy and education programs about the feeding of young children. 
 
Questions and further information 
 
Participation in this study is completely voluntary. Also, you have the option to stop participating and 
withdraw from the study at any time without any problems. 
 
If you have any questions or would like further information about this research, please contact Dr. Kyly 
Whitfield, the Principal Investigator, at kyly.whitfield@msvu.ca, or by phone at (902) 457-5978.  
 
If you have questions about how this study is being conducted and wish to speak with someone who is not 
directly involved in the study, you may contact the MSVU Research Office at (902) 457-6350 or via e-mail at 
research@msvu.ca.  
 
You can also contact the UPEI Research Ethics Board at (902) 620-5104, or by email at reb@upei.ca if you 
have any concerns about the ethical conduct of this study. 
 
Research Results 
 
A summary of research results will be made available online at mamalab.ca. The ethical components of this 
research study have been reviewed by the Research Ethics Boards at Mount Saint Vincent University and 
the University of Prince Edward Island. 
 
 

REFINE Study 
 
Consent Form: Interviews 
Page 4 of 4 
Version 3.1. September 27, 2019. 
 
 
 
  
 
 
Consent Form for Research Participation 
 
PARTICIPANT AUTHORIZATION 
I have read or had read to me this information and authorization form. I have had the chance to ask 
questions. My questions have been answered to my satisfaction before moving forward. I understand the 
nature of the study. I also understand the potential risks. I understand that I have the right to withdraw 
from the study at any time without any problems. I have received a copy of the Consent Form for future 
reference. I freely agree to participate in this research study. 
 
INTERVIEW 
We would like to invite you for one-on-one interview. We will ask you to tell us about things such as why 
you pump milk, how you store and feed milk, your perceptions and experiences feeding your infant, if or 
where you obtained information or advice about infant feeding, and about whether you’ve ever experienced 
stigma regarding how you’ve fed your infant. 
I agree to be interviewed as a part of this research study.  
       YES                      NO 
 
AUDIO RECORDING 
We would like to audio record your interview in order to analyze it later on. We will transcribe it verbatim, 
clean from any identifiers and substitute all names with pseudonyms.  
I agree for my interview to be audio recorded.  
 
       YES                      NO 
 
QUOTES 
There is a possibility that we would like to quote your interview responses in publications and presentations. 
We will substitute your name with a pseudonym.  
I agree for my interview responses to be quoted in publications and presentations.  
 
       YES                      NO 
 
Print name of Participant: ________________________________________________  
Date: _______________________  Signature: _______________________________________________ 
STATEMENT BY PERSON PROVIDING INFORMATION ON STUDY AND OBTAINING CONSENT 
I have explained the nature and demands of the research study and judge that the participant named above understands the nature and demands 
of the study. I have explained the nature of the consent process to the participant and judge that they understand that participation is voluntary 
and that they may withdraw at any time from participating. 
 
Print name of Person Explaining Consent: ________________________________Date: _____________Signature: ____________________