Condition category
Pregnancy and Childbirth
Date applied
15/07/2013
Date assigned
26/07/2013
Last edited
26/09/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 mother’s 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 Women’s 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

http://www.womenscollegehospital.ca/

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

Publication citations

Additional files

Editorial Notes