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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03400605
Other study ID # 34482-3
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 17, 2017
Est. completion date October 13, 2020

Study information

Verified date May 2023
Source University of Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In Toronto Ontario, the Parkdale Community Health Centre operates a community outreach program entitled Parkdale Parents' Primary Prevention Project (5P's). The 5P's provides weekly pre- and post-natal support and education programs for clients. This includes an infant feeding program for mothers with infants 0-6 months (Feeding Tiny Souls). The 5P's has a diverse client-base; the program is aimed at women who are in challenging life circumstances, therefore, clients may include low-income or single mothers and newcomers to Canada. The aim of this project is to investigate the incidence, duration and exclusivity of breastfeeding and timely complementary feeding based on level of maternal participation in components of a pre and postnatal community outreach program. Exploring infant feeding practices is an evaluation component that will not only characterize infant feeding practices within a vulnerable population, but will elucidate whether there are areas of concern that need to be expanded upon within pre or postnatal programming. A prospective infant feeding questionnaire will be administered to participants at 2 weeks and at 2, 4 and 6 months postpartum. The study population will consist of women who enrolled in 5P's prenatally. The hypothesis is that exclusive breastfeeding rates will be low, but higher breastfeeding rates will be observed among women who utilize provided postnatal services more readily.


Recruitment information / eligibility

Status Completed
Enrollment 203
Est. completion date October 13, 2020
Est. primary completion date October 13, 2020
Accepts healthy volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Enrolled in Parkdale Parents' Primary Prevention Project (5P's) prenatally - Enrolled prenatally in 5P's as of August 17, 2017 onwards Exclusion Criteria: - Only enrolled in Parkdale Parents' Primary Prevention Project (5P's) postnatally - Unavailable to participate in infant feeding questionnaire by telephone or in-person during 5P's programming

Study Design


Intervention

Other:
Infant feeding questionnaire
Prospective infant feeding questionnaire administered over the telephone or in-person at 2 weeks and at 2, 4 and 6 months postpartum

Locations

Country Name City State
Canada Parkdale Community Health Centre Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Francis J, Mildon A, Stewart S, Underhill B, Ismail S, Di Ruggiero E, Tarasuk V, Sellen DW, O'Connor DL. Breastfeeding rates are high in a prenatal community support program targeting vulnerable women and offering enhanced postnatal lactation support: a p — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Exclusive breastfeeding as assessed by responses to an infant feeding questionnaire Reported exclusive breastfeeding from birth to 6 months in response to a prospective infant feeding questionnaire birth to 6 months postpartum
Secondary Breastfeeding initiation as assessed by responses to an infant feeding questionnaire administered at 2 weeks postpartum Reported started breastfeeding at birth in response to a prospective infant feeding questionnaire birth to 2 weeks postpartum
Secondary Breastfeeding duration as assessed by responses to an infant feeding questionnaire administered at 2 weeks and 2, 4 and 6 months postpartum Reported length of breastfeeding from birth to 6 months in response to a prospective infant feeding questionnaire birth to 6 months
Secondary Introduction of complementary foods as assessed by responses to an infant feeding questionnaire administered at 2 weeks and 2, 4 and 6 months postpartum 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
Secondary Types of complementary foods introduced as assessed by responses to a prospective infant feeding questionnaire administered at 2 weeks and 2, 4 and 6 months postpartum Reported types of foods introduced to infants from birth to 6 months in response to an infant feeding questionnaire birth to 6 months
Secondary Vitamin and mineral supplementation as assessed by responses to an infant feeding questionnaire administered at 2 weeks and 2, 4 and 6 months postpartum Reported provision of vitamin or mineral supplementation to infants from birth to 6 months in response to a prospective infant feeding questionnaire birth to 6 months
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