Plain English Summary
Background and study aims
The World Health Organization, Canadian Paediatric Society and the American Academy of Pediatrics all recommend breastfeeding as the best method of infant feeding. These recommendations suggest that infants be breastfed exclusively for the first 6 months of life and then, once other foods have been introduced, continue to be breastfed until 2 years and beyond. This strong recommendation is based on evidence that breastfeeding offers important health benefits for both mothers and infants. Despite these benefits and a breastfeeding initiation rate of 90% in Canada, a recent nation-wide survey found that only 27% of mothers are exclusively breastfeeding to 6 months after giving birth (postpartum). Exclusive breastfeeding and breastfeeding duration depends on a mothers confidence in her ability to breastfeed (breastfeeding self-efficacy) in a period shortly after giving birth. The goal of this study is to determine whether or not a breastfeeding self-efficacy enhancing intervention (BSEI) can improve breastfeeding exclusivity rates at 6 months postpartum.
Who can participate?
This trial aims to recruit 956 breastfeeding, first-time mothers (primiparous) aged ≥ 18 years from across participating hospitals in the Greater Toronto Area (GTA). Participants must have access to a telephone, speak and understand English, have a singleton birth, and the infant must be ≥ 37 weeks old at the time of delivery. Mothers must have the intention to exclusively breastfeed. Both the mother and infant must be discharged from hospital together and not have a health condition that could interfere with breastfeeding (e.g., severe illness, major congenital anomaly). The mother should not have had a breast reduction surgery.
What does the study involve?
All in-hospital, primiparous (pregnant for the first time), breastfeeding mothers will be briefly introduced to the study by a staff nurse on the postpartum unit and asked for permission to be contacted by the research nurse. If the mother agrees, the research nurse will provide a detailed study explanation, assess for eligibility, and obtain written informed consent. Following the collection of baseline information, all eligible, consenting mothers will be randomly allocated to the intervention group (BSEI) or control group (the standard in-hospital and community postpartum care). A research assistant will telephone all participants at 3, 6, 9, and 12 months postpartum to collect follow-up information.
What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part. However, the results from this trial are likely to present valuable information regarding breastfeeding behaviours across the first year postpartum in a diverse Canadian sample. If participants indicate that they may harm their baby or any other children, child welfare services will be contacted, as required by law. In the event of any immediate safety concerns or danger, emergency services (9-1-1) will be called. In these rare instances, participation may indicate possible social and legal risks.
Where is the study run from?
The trial has been set up by the Womens College Hospital and University of Toronto in collaboration with three large hospitals in Ontario. The Data Coordinating Centre is located at the University of Toronto.
When is the study starting and how long is it expected to run for?
It is anticipated that recruitment will start in January 2014. Participants will be enrolled in the study for a period of 1 year and follow-up interviews will continue to 1 year postpartum.
Who is funding the study?
Funding has been provided by the Canadian Institutes of Health Research (CIHR).
Who is the main contact?
Principal Investigator Dr. Cindy-Lee Dennis, cindylee.dennis@utoronto.ca
Research Manager Melissa Jovellanos, melissa.jovellanos@utoronto.ca
Trial website
Contact information
Type
Scientific
Primary contact
Dr Cindy-Lee Dennis
ORCID ID
Contact details
Lawrence S. Bloomberg Faculty of Nursing
University of Toronto
130-155 College Street
Toronto
M5T 1P8
Canada
cindylee.dennis@utoronto.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised controlled trial to evaluate the effect of a breastfeeding self-efficacy enhancing intervention on breastfeeding exclusivity among primiparous mothers
Acronym
WISE
Study hypothesis
What is the effect of a breastfeeding self-efficacy enhancing intervention provided by combined nurse and peer mentor support on breastfeeding exclusivity among primiparous mothers at 6 months postpartum?
Ethics approval
1. University of Toronto Office of Research Ethics, 30/01/2014, protocol # 29656
2. The Scarborough Hospital Research Ethics Board , 20/01/2014, protocol # PAED-12
3. William Osler Health System Research Ethics Board, 09/02/2014
4. Thunder Bay Regional Health Sciences Centre Research Ethics Office, 11/03/2014, protocol # 2013156
Study design
Multi-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Breastfeeding exclusivity among primiparous mothers at 6 months postpartum
Intervention
Participants allocated to the intervention group will receive standard postpartum care plus four individualized self-efficacy enhancing sessions with a trained research nurse; mothers will also be offered telephone-based peer support following hospital discharge up to 12 months postpartum.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Breastfeeding exclusivity as identified by the Infant Feeding Questionnaire administered at 6 months postpartum
Secondary outcome measures
What is the effect of the breastfeeding self-efficacy intervention (BSEI) on:
1. Breastfeeding exclusivity at 3 months postpartum?
2. Breastfeeding duration at 3, 6, 9, and 12 months postpartum?
3. Breastfeeding difficulties at 3 6, 9, and 12 months postpartum?
4. Health service utilization at 3, 6, 9, and 12 months postpartum?
5. Cost implications
6. Mothers evaluations of their BSEI and peer support experience
7. Nurses and peers reports of the type and intensity of their BSEI activities
Overall trial start date
31/01/2014
Overall trial end date
31/01/2017
Reason abandoned
Eligibility
Participant inclusion criteria
In-hospital breastfeeding mothers who meet the following criteria:
1. Primiparous
2. Aged above 18 years
3. Singleton birth
4. Infant greater than or equal to 37 weeks gestational age at delivery
5. Can speak and understand English.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
956
Participant exclusion criteria
1. Maternal/infant health condition that could interfere with breastfeeding (e.g., severe illness, major congenital anomaly)
2. Infant not expected to be discharged home with mother
3. No telephone access
4. Maternal breast reduction surgery
5. Maternal intention to not exclusively breastfeed
Recruitment start date
31/01/2014
Recruitment end date
31/01/2017
Locations
Countries of recruitment
Canada
Trial participating centre
Lawrence S. Bloomberg Faculty of Nursing
Toronto
M5T 1P8
Canada
Sponsor information
Organisation
Women's College Hospital (Canada)
Sponsor details
76 Grenville St.
Toronto
ON
M5S 1B2
Canada
+1 416 323 6400
Diana.Raymond-Watts@wchospital.ca
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Canadian Institutes of Health Research (CIHR) (Canada)
Alternative name(s)
Instituts de Recherche en Santé du Canada, CIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Canada
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary