Providing Postnatal Breastfeeding Support Through the Canada Prenatal Nutrition Program

NCT03589963 | Terminated

• 1 other identifier: 123345
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breastfeeding; Breastfeeding, Exclusive; Infant Nutrition; Complementary Feeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Duration of any breastfeeding in the first six months postpartum

  birth to 6 months postpartum

• Duration of exclusive breastfeeding in the first six months postpartum

  birth to 6 months postpartum

• Age of introduction of breastmilk substitutes

  birth to 6 months postpartum

• Age of introduction of complementary foods

  birth to 6 months postpartum

Study Arms (2)

Pre-intervention

NO INTERVENTION

regular CPNP programming

Post-intervention

EXPERIMENTAL

regular CPNP programming plus access to postnatal lactation support

Behavioral: Postnatal Lactation Support

Interventions

Postnatal Lactation Support BEHAVIORAL

In-home breastfeeding support delivered by professional lactation consultants and provision of a high-quality breast pump

Post-intervention

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Toronto: lead
• Sprott Foundation: collaborator
• Parkdale Queen West Community Health Centre: collaborator

Study Sites (2)

Parkdale Queen West Community Health Centre

Toronto, Ontario, M5V 2R4, Canada

Location

The Stop Community Food Centre

Toronto, Ontario, M6H 4E1, Canada

Location

Related Publications (3)

• 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.

  PMID: 35676013 DERIVED

• 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.

  PMID: 34369075 DERIVED

• 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.

  PMID: 34215288 DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Daniel Sellen, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

• Deborah O'Connor, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: July 18, 2018
• Study Start: November 1, 2018
• Primary Completion: July 13, 2021
• Study Completion: July 13, 2021
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

CA (2)