Providing Postnatal Breastfeeding Support Through the Canada Prenatal Nutrition Program (PINSTEP-4)

Effectiveness and Feasibility of Providing Postnatal Breastfeeding Support to Vulnerable Mothers as an Extension to the Canada Prenatal Nutrition Program

The Canada Prenatal Nutrition Program (CPNP) aims to improve birth outcomes among Canadian women in challenging life circumstances, including those who are adolescents, newcomers, low-income or single mothers. The CPNP strongly promotes breastfeeding prenatally, resulting in high initiation rates, but continued postnatal support is needed to optimize breastfeeding duration and exclusivity.

The aim of this research is to investigate the effects of adding postnatal lactation support as an extension to the CPNP on breastfeeding duration and exclusivity in the first six months postpartum. The research will be conducted at two CPNP sites in Toronto, Parkdale Queen West Community Health Centre and The Stop Community Food Centre. A quasi-experimental design will be used to compare the infant feeding practices of CPNP clients before and after introduction of a postnatal lactation support intervention which will include in-home professional lactation support and provision of high-quality breast pumps. These services will be delivered as CPNP program components and will be accessible to all clients at the two participating sites during the post-intervention period. Infant feeding practices will be assessed by a questionnaire administered at 2 weeks, 1, 2, 3, 4, 5 and 6 months postpartum. The hypothesis is that significantly more mothers in the post-intervention group will be exclusively breastfeeding at four months postpartum. The effect is expected to be mediated through increased breastfeeding self-efficacy, which will be assessed using validated scales prenatally and at 2 weeks and 2 months postpartum.

Study Overview

• Status: Terminated
• Conditions: Breastfeeding; Breastfeeding, Exclusive; Complementary Feeding; Infant Nutrition
• Intervention / Treatment: Behavioral: Postnatal Lactation Support

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5V 2R4
      • Parkdale Queen West Community Health Centre
    • Toronto, Ontario, Canada, M6H 4E1
      • The Stop Community Food Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 49 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• CPNP clients registered prenatally
• intention to initiate breastfeeding
• intention to remain in Toronto with the infant for 6 months postpartum
• willing to share contact information
• birth at 34 weeks gestation or later

Exclusion Criteria:

• preterm birth (below 34 weeks)
• infant has congenital abnormality or medical condition affecting feeding
• mother or infant still in hospital at 2 weeks postpartum

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Pre-intervention; regular CPNP programming
Experimental: Post-intervention; regular CPNP programming plus access to postnatal lactation support	Behavioral: Postnatal Lactation Support; In-home breastfeeding support delivered by professional lactation consultants and provision of a high-quality breast pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exclusive breastfeeding at 4 months postpartum	Reported exclusive breastfeeding at four months postpartum assessed by a prospective infant feeding questionnaire	birth to 4 months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of any breastfeeding in the first six months postpartum	Duration of any breastfeeding from birth to 6 months assessed by a prospective infant feeding questionnaire	birth to 6 months postpartum
Duration of exclusive breastfeeding in the first six months postpartum	Duration of exclusive breastfeeding from birth to 6 months assessed by a prospective infant feeding questionnaire	birth to 6 months postpartum
Age of introduction of breastmilk substitutes	Reported timing of the introduction of breastmilk substitutes from birth to 6 months in response to a prospective infant feeding questionnaire	birth to 6 months postpartum
Age of introduction of complementary foods	Reported timing of the introduction of complementary foods from birth to 6 months in response to a prospective infant feeding questionnaire	birth to 6 months postpartum

Collaborators and Investigators

• Sponsor: University of Toronto
• Collaborators: Sprott Foundation; Parkdale Queen West Community Health Centre
• Investigators: Principal Investigator: Daniel Sellen, PhD, University of Toronto; Principal Investigator: Deborah O'Connor, PhD, University of Toronto

Publications and helpful links

General Publications

• Mildon A, Francis J, Stewart S, Underhill B, Ng YM, Rousseau C, Di Ruggiero E, Dennis CL, Kiss A, O'Connor DL, Sellen DW. Associations between use of expressed human milk at 2 weeks postpartum and human milk feeding practices to 6 months: a prospective cohort study with vulnerable women in Toronto, Canada. BMJ Open. 2022 Jun 8;12(6):e055830. doi: 10.1136/bmjopen-2021-055830.
• Mildon A, Francis J, Stewart S, Underhill B, Ng YM, Rousseau C, Di Ruggiero E, Dennis CL, O'Connor DL, Sellen DW. High levels of breastmilk feeding despite a low rate of exclusive breastfeeding for 6 months in a cohort of vulnerable women in Toronto, Canada. Matern Child Nutr. 2022 Jan;18(1):e13260. doi: 10.1111/mcn.13260. Epub 2021 Aug 8.
• Mildon A, Francis J, Stewart S, Underhill B, Ng YM, Richards E, Rousseau C, Di Ruggiero E, Dennis CL, O'Connor DL, Sellen DW. Effect on breastfeeding practices of providing in-home lactation support to vulnerable women through the Canada Prenatal Nutrition Program: protocol for a pre/post intervention study. Int Breastfeed J. 2021 Jul 2;16(1):49. doi: 10.1186/s13006-021-00396-y. Erratum in: Int Breastfeed J. 2021 Jul 29;16(1):57.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): July 13, 2021
• Study Completion (Actual): July 13, 2021

Study Registration Dates

• First Submitted: July 6, 2018
• First Submitted That Met QC Criteria: July 6, 2018
• First Posted (Actual): July 18, 2018

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 123345

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No