Prenatal Community ProgramPINSTEP-1NCT03372408
Parkdale Infant Nutrition Security Targeted Evaluation Project: Chart Review
An observational study of Prenatal Community Program and Vulnerable Population, 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 only
- Conditions the study is for
- Prenatal Community Program, Vulnerable Population, Postnatal Community Program
- What is being tested?
- Chart review
- How many people
- 338 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jun 2018to 30 Aug 2019
- 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
- Child, Adult, Older adult
Study population: Clients enrolled in Parkdale Parents' Primary Prevention Project (5P's) in Toronto, Ontario, Canada.
Who may be able to join
- Enrolled in Parkdale Parents' Primary Prevention Project (5P's) prenatally
- 5P's client signed the permission to release information on the 5P's intake form
Who cannot join
- Only attended Parkdale Parents' Primary Prevention Project (5P's) postnatally
- 5P's client did not sign the permission to release information on the 5P's intake form
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 1-Retrospective Chart Review)
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.
It is important to know who is accessing community programs and what the drivers of program utilization are in order to better support the women who are enrolled and to target those who are not. The aim of this project is twofold: 1) to investigate what socio-demographic and psychosocial characteristics predict level of participation in a prenatal community outreach program targeting vulnerable mothers and 2) based on utilization of a prenatal program, are there differences in the use of a postnatal program? This study will be conducted through a retrospective chart review. The study population will consist of women who enrolled in 5P's prenatally. The hypothesis is that more vulnerable women will not attend programming as frequently.
- Being tested
- Chart review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chart reviewOther
Retrospective chart review of program participation and socio-demographic \& psychosocial characteristics
| Study group | Role | What they receive |
|---|---|---|
| Program Clients | Parkdale Parents' Primary Prevention Project (5P's) clients Receives: Other: Chart review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of program participation as assessed by review of client records and program attendance records
Retrospective chart review of client program records and attendance
Measured: Registration to prenatal program until 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start4 Jun 2018
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
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 Prenatal Community ProgramStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 338 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
- NCT03372408
- Sponsor's protocol ID
- 34482-1
- Acronym
- PINSTEP-1
- Status last verified
- Apr 2022
- First submitted
- 8 Dec 2017
- Last updated
- 4 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Francis J, Ismail S, Mildon A, Stewart S, Underhill B, Tarasuk V, Di Ruggiero E, Kiss A, Sellen DW, O'Connor DL. Characteristics of vulnerable women and their association with participation in a Canada Prenatal Nutrition Program site in Toronto, Canada. Health Promot Chronic Dis Prev Can. 2021 Dec;41(12):413-422. doi: 10.24095/hpcdp.41.12.02.
PubMed 34910898
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 1-Retrospective Chart Review)
- ClinicalTrials.gov ID
- NCT03372408
- Acronym / sponsor ID
- PINSTEP-1 / 34482-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 13 Dec 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.
It is important to know who is accessing community programs and what the drivers of program utilization are in order to better support the women who are enrolled and to target those who are not. The aim of this project is twofold: 1) to investigate what socio-demographic and psychosocial characteristics predict level of participation in a prenatal community outreach program targeting vulnerable mothers and 2) based on utilization of a prenatal program, are there differences in the use of a postnatal program? This study will be conducted through a retrospective chart review. The study population will consist of women who enrolled in 5P's prenatally. The hypothesis is that more vulnerable women will not attend programming as frequently.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Program Clients | – | Other: Chart reviewParkdale Parents' Primary Prevention Project (5P's) clients |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Clients enrolled in Parkdale Parents' Primary Prevention Project (5P's) in Toronto, Ontario, Canada.
Key inclusion criteria (2 listed)
- Enrolled in Parkdale Parents' Primary Prevention Project (5P's) prenatally
- 5P's client signed the permission to release information on the 5P's intake form
Key exclusion criteria (2 listed)
- Only attended Parkdale Parents' Primary Prevention Project (5P's) postnatally
- 5P's client did not sign the permission to release information on the 5P's intake form
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 |
|---|---|---|
| Chart reviewRetrospective chart review of program participation and socio-demographic \& psychosocial characteristics | Other | Program Clients |
Primary outcome
Level of program participation as assessed by review of client records and program attendance records
Time frame: Registration to prenatal program until 12 months postpartum
Retrospective chart review of client program records and attendance
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 34910898Francis J, Ismail S, Mildon A, Stewart S, Underhill B, Tarasuk V, Di Ruggiero E, Kiss A, Sellen DW, O'Connor DL. Characteristics of vulnerable women and their association with participation in a Canada Prenatal Nutrition Program site in Toronto, Canada. Health Promot Chronic Dis Prev Can. 2021 Dec;41(12):413-422. doi: 10.24095/hpcdp.41.12.02.
- Related InfoLink provided by the sponsor.
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 Prenatal Community Program and Vulnerable Population, 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?
Level of program participation as assessed by review of client records and program attendance records (time frame: Registration to prenatal program until 12 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 NCT03372408, 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.