NCT03400605

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 17, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2020

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

3.2 years

First QC Date

December 8, 2017

Last Update Submit

May 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Breastfeeding initiation as assessed by responses to an infant feeding questionnaire administered at 2 weeks postpartum

    birth to 2 weeks postpartum

  • Breastfeeding duration as assessed by responses to an infant feeding questionnaire administered at 2 weeks and 2, 4 and 6 months postpartum

    birth to 6 months

  • Introduction of complementary foods as assessed by responses to an infant feeding questionnaire administered at 2 weeks and 2, 4 and 6 months postpartum

    birth to 6 months

  • 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

    birth to 6 months

  • Vitamin and mineral supplementation as assessed by responses to an infant feeding questionnaire administered at 2 weeks and 2, 4 and 6 months postpartum

    birth to 6 months

Study Arms (1)

Program Clients

Parkdale Parents' Primary Prevention Project (5P's) clients

Other: Infant feeding questionnaire

Interventions

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

Program Clients

Eligibility Criteria

Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Clients enrolled in Parkdale Parents' Primary Prevention Project (5P's) at Parkdale Community Health Centre in Toronto, Ontario, Canada.

You may qualify if:

  • Enrolled in Parkdale Parents' Primary Prevention Project (5P's) prenatally
  • Enrolled prenatally in 5P's as of August 17, 2017 onwards

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parkdale Community Health Centre

Toronto, Ontario, M6R 3B2, Canada

Location

Related Publications (2)

  • 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 prospective cohort study. Int J Equity Health. 2021 Mar 3;20(1):71. doi: 10.1186/s12939-021-01386-6.

  • 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.

Related Links

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Jane Francis, MSc

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 8, 2017

First Posted

January 17, 2018

Study Start

August 17, 2017

Primary Completion

October 13, 2020

Study Completion

October 13, 2020

Last Updated

May 11, 2023

Record last verified: 2023-05

Locations