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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03589963
Other study ID # 123345
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date November 1, 2018
Est. completion date July 13, 2021

Study information

Verified date April 2022
Source University of Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 151
Est. completion date July 13, 2021
Est. primary completion date July 13, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 49 Years
Eligibility 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 Design


Intervention

Behavioral:
Postnatal Lactation Support
In-home breastfeeding support delivered by professional lactation consultants and provision of a high-quality breast pump

Locations

Country Name City State
Canada Parkdale Queen West Community Health Centre Toronto Ontario
Canada The Stop Community Food Centre Toronto Ontario

Sponsors (3)

Lead Sponsor Collaborator
University of Toronto Parkdale Queen West Community Health Centre, Sprott Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
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