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

• Sponsor: University of Toronto (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03589963
• Collaborator: Sprott Foundation (Other), Parkdale Queen West Community Health Centre (Other)
• Enrollment: 151
• Locations: 2
• Arms: 2
• Actual Duration (Months): 32.4
• Patients Per Site: 75.5
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breastfeeding; Breastfeeding, Exclusive; Infant Nutrition; Complementary Feeding	Behavioral: Postnatal Lactation Support	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 151 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effectiveness and Feasibility of Providing Postnatal Breastfeeding Support to Vulnerable Mothers as an Extension to the Canada Prenatal Nutrition Program
• Actual Study Start Date: Nov 1, 2018
• Actual Primary Completion Date: Jul 13, 2021
• Actual Study Completion Date: Jul 13, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Exclusive breastfeeding at 4 months postpartum [birth to 4 months postpartum]

   Reported exclusive breastfeeding at four months postpartum assessed by a prospective infant feeding questionnaire

Secondary Outcome Measures

1. Duration of any breastfeeding in the first six months postpartum [birth to 6 months postpartum]

   Duration of any breastfeeding from birth to 6 months assessed by a prospective infant feeding questionnaire

2. Duration of exclusive breastfeeding in the first six months postpartum [birth to 6 months postpartum]

   Duration of exclusive breastfeeding from birth to 6 months assessed by a prospective infant feeding questionnaire

3. Age of introduction of breastmilk substitutes [birth to 6 months postpartum]

   Reported timing of the introduction of breastmilk substitutes from birth to 6 months in response to a prospective infant feeding questionnaire

4. Age of introduction of complementary foods [birth to 6 months postpartum]

   Reported timing of the introduction of complementary foods from birth to 6 months in response to a prospective infant feeding questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 49 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Parkdale Queen West Community Health Centre	Toronto	Ontario	Canada	M5V 2R4
2	The Stop Community Food Centre	Toronto	Ontario	Canada	M6H 4E1

Sponsors and Collaborators

• University of Toronto
• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daniel Sellen, Professor, University of Toronto
• ClinicalTrials.gov Identifier: NCT03589963
• Other Study ID Numbers: 123345
• First Posted: Jul 18, 2018
• Last Update Posted: May 2, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 2, 2022