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CompletedNCT03305406PINSTEP-2Updated May 4, 2022

Parkdale Infant Nutrition Security Targeted Evaluation Project: Focus Groups & Interviews

An observational study in Breastfeeding, Breast Pumping and Infant Nutrition, sponsored by University of Toronto. Completed at 1 site in Canada. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-04.

Sponsored by University of Toronto · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
51
Sex
Female
01

Study 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.

02

Conditions studied

  • Breastfeeding
  • Breast Pumping
  • Infant Nutrition
  • Vulnerable Population
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-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

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

Exclusion Criteria:

  • Unavailable to participate in a focus group or interview
  • Only attended Parkdale Parents' Primary Prevention Project (5P's) postnatally
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
51 participants (actual)
Patient registry
No

Groups and cohorts

  • Focus Group Participants

    Semi-structured focus groups

    Other: Focus groups

  • Interview Participants

    One-on-one interviews

    Other: Interviews

Interventions

  • OtherFocus groups

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

  • OtherInterviews

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

05

What researchers measure

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

    Time frame: 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

    Qualitative summary of perceptions and experiences of accessibility regarding a community infant feeding program

    Time frame: 60 minutes (participants are 1-14 months postpartum)

06

Study locations

1 site
  • Parkdale Community Health Centre
    Toronto, Ontario M6R 3B2, Canada
07

References and documents

Publications

  • 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. PubMed 31984642 ↗
08

Registry details

Key details

Study ID
NCT03305406
Lead sponsor
University of Toronto
Responsible party
Daniel Sellen (Professor, University of Toronto) — Principal investigator
First posted
Oct 10, 2017
Start date
Aug 18, 2017
Primary completion
Dec 20, 2017
Completion
Dec 20, 2017
Last update
May 4, 2022

Study contacts

Jane Francis, MSc
principal investigator · University of Toronto

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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