Providing Postnatal Breastfeeding Support Through the Canada Prenatal Nutrition Program

NCT ID: NCT03589963

Last Updated: 2022-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2021-07-13

Brief Summary

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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.

Detailed Description

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Conditions

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Breastfeeding Breastfeeding, Exclusive Infant Nutrition Complementary Feeding

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Pre-intervention

regular CPNP programming

Group Type NO_INTERVENTION

No interventions assigned to this group

Post-intervention

regular CPNP programming plus access to postnatal lactation support

Group Type EXPERIMENTAL

Postnatal Lactation Support

Intervention Type BEHAVIORAL

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

Interventions

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Postnatal Lactation Support

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sprott Foundation

UNKNOWN

Sponsor Role collaborator

Parkdale Queen West Community Health Centre

UNKNOWN

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role lead

Responsible Party

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Daniel Sellen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Sellen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Deborah O'Connor, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

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Parkdale Queen West Community Health Centre

Toronto, Ontario, Canada

Site Status

The Stop Community Food Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 35676013 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34369075 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34215288 (View on PubMed)

Other Identifiers

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123345

Identifier Type: -

Identifier Source: org_study_id

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