Clinical trial NCT03589963: Providing Postnatal Breastfeeding Support Through the Canada Prenatal Nutrition Program
Official title: Effectiveness and Feasibility of Providing Postnatal Breastfeeding Support to Vulnerable Mothers as an Extension to the Canada Prenatal Nutrition Program
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breastfeeding
Breastfeeding, Exclusive
Infant Nutrition
Complementary Feeding
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Sprott Foundation
name: Parkdale Queen West Community Health Centre
First posted: 2018-07-18
Enrollment: 151
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Exclusive breastfeeding at 4 months postpartum
timeFrame: birth to 4 months postpartum
Secondary outcomes:
measure: Duration of any breastfeeding in the first six months postpartum
timeFrame: birth to 6 months postpartum
measure: Duration of exclusive breastfeeding in the first six months postpartum
timeFrame: birth to 6 months postpartum
measure: Age of introduction of breastmilk substitutes
timeFrame: birth to 6 months postpartum
measure: Age of introduction of complementary foods
timeFrame: birth to 6 months postpartum
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Parkdale Queen West Community Health Centre
state: Ontario
city: Toronto
country: Canada
facility: The Stop Community Food Centre
state: Ontario
Study officials:
affiliation: University of Toronto
name: Daniel Sellen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Deborah O'Connor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.