NCT03305406

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 overall goal of this research is to optimize the existing 5P's program. Program acceptability is an essential component of the process evaluation to understand the experiences of mothers and the perceived supports and barriers of the program. Specifically, the aim of this project is twofold: 1) to investigate the perceptions and experiences of accessibility of a postnatal community program and 2) to explore the perceptions of, and attitudes toward, a community infant feeding program offering lactation consultant and breast pump resources. This study will use a qualitative approach by way of semi-structured focus groups and interviews. The study population will consist of women who enrolled in 5P's prenatally and have delivered their infant. This will include women who did and did not continue to participate in the postnatal program and/or Feeding Tiny Souls after delivery. The investigators will specifically seek women who participated in the prenatal program, but did not take part in the postnatal program and/or Feeding Tiny Souls to understand why participants did not access these resources and gather information on their views of these postnatal program components. The hypothesis is that the postnatal community program is a source of support for clients, but that it needs to be expanded to include more clients and the infant feeding program is an important support for helping clients to provide breast milk to their infant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 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 18, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 27, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 10, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2017

Completed
Last Updated

May 4, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

September 27, 2017

Last Update Submit

April 28, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Perceptions of, and attitudes toward, a community infant feeding program offering lactation consultant and breast pump resources as assessed by group responses to targeted probes during postnatal focus groups and interviews

    Qualitative summary of perceptions and attitudes regarding a community infant feeding program

    60 minutes (participants are 1-14 months postpartum)

Secondary Outcomes (1)

  • Perceptions and experiences of accessibility of a postnatal community program as assessed by group responses to targeted probes during postnatal focus groups and interviews

    60 minutes (participants are 1-14 months postpartum)

Study Arms (2)

Focus Group Participants

Semi-structured focus groups

Other: Focus groups

Interview Participants

One-on-one interviews

Other: Interviews

Interventions

Focus groups will be conducted to gather information on clients view of a community support program focusing on healthy infant nutrition

Focus Group Participants

Interviews will be conducted to gather information on clients view of a community support program focusing on healthy infant nutrition

Interview Participants

Eligibility Criteria

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

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

You may qualify if:

  • Enrolled in Parkdale Parents' Primary Prevention Project (5P's) prenatally
  • Delivered their infant between June 1, 2016 and August 16, 2017

You may not qualify if:

  • Unavailable to participate in a focus group or interview
  • Only attended Parkdale Parents' Primary Prevention Project (5P's) postnatally

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parkdale Community Health Centre

Toronto, Ontario, M6R 3B2, Canada

Location

Related Publications (1)

  • Francis J, Mildon A, Stewart S, Underhill B, Tarasuk V, Di Ruggiero E, Sellen D, O'Connor DL. Vulnerable mothers' experiences breastfeeding with an enhanced community lactation support program. Matern Child Nutr. 2020 Jul;16(3):e12957. doi: 10.1111/mcn.12957. Epub 2020 Jan 26.

MeSH Terms

Conditions

Breast FeedingBreast Milk Expression

Interventions

Focus GroupsInterviews as Topic

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

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

September 27, 2017

First Posted

October 10, 2017

Study Start

August 18, 2017

Primary Completion

December 20, 2017

Study Completion

December 20, 2017

Last Updated

May 4, 2022

Record last verified: 2022-04

Locations