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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03305406
Other study ID # 34482-2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 18, 2017
Est. completion date December 20, 2017

Study information

Verified date April 2022
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 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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date December 20, 2017
Est. primary completion date December 20, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Enrolled in Parkdale Parents' Primary Prevention Project (5P's) prenatally - Delivered their infant between June 1, 2016 and August 16, 2017 Exclusion Criteria: - Unavailable to participate in a focus group or interview - Only attended Parkdale Parents' Primary Prevention Project (5P's) postnatally

Study Design


Intervention

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

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, 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.12 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Perceptions and experiences of accessibility of a postnatal community program as assessed by group responses to targeted probes during postnatal focus groups and interviews Qualitative summary of perceptions and experiences of accessibility regarding a community infant feeding program 60 minutes (participants are 1-14 months postpartum)
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