BreastfeedingPINSTEP-2NCT03305406
Parkdale Infant Nutrition Security Targeted Evaluation Project: Focus Groups & Interviews
An observational study of Breastfeeding and Breast Pumping, run by University of Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Breast Pumping, Infant Nutrition
- What is being tested?
- Focus groups and Interviews
- How many people
- 51 participants
- Where
- 1 siteCanada
- Study dates
- 18 Aug 2017to 20 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Clients enrolled in the Parkdale Parents' Primary Prevention Project (5P's) at the Parkdale Community Health Centre in Toronto, Ontario, Canada
Who may be able to join
- Enrolled in Parkdale Parents' Primary Prevention Project (5P's) prenatally
- Delivered their infant between June 1, 2016 and August 16, 2017
Who cannot join
- Unavailable to participate in a focus group or interview
- Only attended Parkdale Parents' Primary Prevention Project (5P's) postnatally
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Breastfeeding, Breast Pumping, Infant Nutrition, Vulnerable Population
- Being tested
- Focus groups, Interviews
- Medical subject headings
- Breast Feeding, Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus groupsOther
Focus groups will be conducted to gather information on clients view of a community support program focusing on healthy infant nutrition
InterviewsOther
Interviews will be conducted to gather information on clients view of a community support program focusing on healthy infant nutrition
| Study group | Role | What they receive |
|---|---|---|
| Focus Group Participants | Semi-structured focus groups Receives: Other: Focus groups | |
| Interview Participants | One-on-one interviews Receives: Other: Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 60 minutes (participants are 1-14 months postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start18 Aug 2017
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Sellen, University of Toronto
- Investigators
- Jane Francis, MSc, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305406
- Sponsor's protocol ID
- 34482-2
- Acronym
- PINSTEP-2
- Status last verified
- Apr 2022
- First submitted
- 27 Sep 2017
- Last updated
- 4 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parkdale Infant Nutrition Security Targeted Evaluation Project (PINSTEP): Formative Research (Objective 2-Focus Group & Interview)
- ClinicalTrials.gov ID
- NCT03305406
- Acronym / sponsor ID
- PINSTEP-2 / 34482-2
- Conditions
- Breastfeeding, Breast Pumping, Infant Nutrition, Vulnerable Population
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 18 Aug 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 10 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Focus Group Participants | – | Other: Focus groupsSemi-structured focus groups |
| Interview Participants | – | Other: InterviewsOne-on-one interviews |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Clients enrolled in the Parkdale Parents' Primary Prevention Project (5P's) at the Parkdale Community Health Centre in Toronto, Ontario, Canada
Key inclusion criteria (2 listed)
- Enrolled in Parkdale Parents' Primary Prevention Project (5P's) prenatally
- Delivered their infant between June 1, 2016 and August 16, 2017
Key exclusion criteria (2 listed)
- Unavailable to participate in a focus group or interview
- Only attended Parkdale Parents' Primary Prevention Project (5P's) postnatally
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus groupsFocus groups will be conducted to gather information on clients view of a community support program focusing on healthy infant nutrition | Other | Focus Group Participants |
| InterviewsInterviews will be conducted to gather information on clients view of a community support program focusing on healthy infant nutrition | Other | Interview Participants |
Primary outcome
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
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Results publication: PubMed 31984642Francis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Francis, MSc principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breastfeeding and Breast Pumping, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03305406, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.