- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03305406
Parkdale Infant Nutrition Security Targeted Evaluation Project: Focus Groups & Interviews (PINSTEP-2)
Parkdale Infant Nutrition Security Targeted Evaluation Project (PINSTEP): Formative Research (Objective 2-Focus Group & Interview)
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M6R 3B2
- Parkdale Community Health Centre
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Focus Group Participants
Semi-structured focus groups
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Focus groups will be conducted to gather information on clients view of a community support program focusing on healthy infant nutrition
|
Interview Participants
One-on-one interviews
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Interviews will be conducted to gather information on clients view of a community support program focusing on healthy infant nutrition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 60 minutes (participants are 1-14 months postpartum)
|
Qualitative summary of perceptions and attitudes regarding a community infant feeding program
|
60 minutes (participants are 1-14 months postpartum)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceptions and experiences of accessibility of a postnatal community program as assessed by group responses to targeted probes during postnatal focus groups and interviews
Time Frame: 60 minutes (participants are 1-14 months postpartum)
|
Qualitative summary of perceptions and experiences of accessibility regarding a community infant feeding program
|
60 minutes (participants are 1-14 months postpartum)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jane Francis, MSc, University of Toronto
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 34482-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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