ClinicalTrials.gg
CompletedNCT03400605PINSTEP-3Updated May 11, 2023

Parkdale Infant Nutrition Security Targeted Evaluation Project: Infant Feeding

An observational study in Breastfeeding, Breastfeeding, Exclusive and Infant Nutrition, sponsored by University of Toronto. Completed at 1 site in Canada. Open to female participants. Per ClinicalTrials.gov, last updated 2023-05-11.

Sponsored by University of Toronto · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
203
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 33 studies in Breast Feeding with a site in Canada — 4 open to participants now, 8 under way, none of them phase 3. Breast Feeding · Canada.

Enrollment
6th of 11
203 · median 203
Started
2017
with 3 others
Observational
11 of 33
2 open now
Registered
17th of 33
by date
Lead sponsor
5 of 33
University of Toronto

Among the 33 studies in Breast Feeding with a site in Canada, this one is the 6th largest by enrollment of the 11 observational ones that give a count, is one of 4 that started in 2017, is one of 11 observational ones, and was the 17th registered.

Breast Feeding

1,082 studies on the registry are indexed under Breast Feeding; 218 are open to participants now.

Browse Breast Feeding studies →

Open to participants now

4 of the 33 studies in Breast Feeding with a site in Canada are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 128 Breast Feeding studies recruiting now, 67 (52%) set no upper age limit and 59 (46%) stop at 75 or younger; 54 take children under 18; 76 take healthy volunteers.

This study: female.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 33 studies in Breast Feeding with a site in Canada, or all of them as a file.
02

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 aim of this project is to investigate the incidence, duration and exclusivity of breastfeeding and timely complementary feeding based on level of maternal participation in components of a pre and postnatal community outreach program. Exploring infant feeding practices is an evaluation component that will not only characterize infant feeding practices within a vulnerable population, but will elucidate whether there are areas of concern that need to be expanded upon within pre or postnatal programming. A prospective infant feeding questionnaire will be administered to participants at 2 weeks and at 2, 4 and 6 months postpartum. The study population will consist of women who enrolled in 5P's prenatally. The hypothesis is that exclusive breastfeeding rates will be low, but higher breastfeeding rates will be observed among women who utilize provided postnatal services more readily.

03

Conditions studied

  • Breastfeeding
  • Breastfeeding, Exclusive
  • Infant Nutrition
  • Vulnerable Population
  • Complementary Feeding
  • Food Security

Browse trials for

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

Clients enrolled in Parkdale Parents' Primary Prevention Project (5P's) at Parkdale Community Health Centre in Toronto, Ontario, Canada.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Enrolled in Parkdale Parents' Primary Prevention Project (5P's) prenatally
  • Enrolled prenatally in 5P's as of August 17, 2017 onwards

Exclusion criteria

Exclusion Criteria:

  • Only enrolled in Parkdale Parents' Primary Prevention Project (5P's) postnatally
  • Unavailable to participate in infant feeding questionnaire by telephone or in-person during 5P's programming
05

Study design

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

Groups and cohorts

  • Program Clients

    Parkdale Parents' Primary Prevention Project (5P's) clients

    Other: Infant feeding questionnaire

Interventions

  • OtherInfant feeding questionnaire

    Prospective infant feeding questionnaire administered over the telephone or in-person at 2 weeks and at 2, 4 and 6 months postpartum

06

What researchers measure

Primary outcomes

  1. Exclusive breastfeeding as assessed by responses to an infant feeding questionnaire

    Reported exclusive breastfeeding from birth to 6 months in response to a prospective infant feeding questionnaire

    Time frame: birth to 6 months postpartum

Secondary outcomes

  1. Breastfeeding initiation as assessed by responses to an infant feeding questionnaire administered at 2 weeks postpartum

    Reported started breastfeeding at birth in response to a prospective infant feeding questionnaire

    Time frame: birth to 2 weeks postpartum

  2. Breastfeeding duration as assessed by responses to an infant feeding questionnaire administered at 2 weeks and 2, 4 and 6 months postpartum

    Reported length of breastfeeding from birth to 6 months in response to a prospective infant feeding questionnaire

    Time frame: birth to 6 months

  3. Introduction of complementary foods as assessed by responses to an infant feeding questionnaire administered at 2 weeks and 2, 4 and 6 months postpartum

    Reported timing of the introduction of complementary foods from birth to 6 months in response to a prospective infant feeding questionnaire

    Time frame: birth to 6 months

  4. Types of complementary foods introduced as assessed by responses to a prospective infant feeding questionnaire administered at 2 weeks and 2, 4 and 6 months postpartum

    Reported types of foods introduced to infants from birth to 6 months in response to an infant feeding questionnaire

    Time frame: birth to 6 months

  5. Vitamin and mineral supplementation as assessed by responses to an infant feeding questionnaire administered at 2 weeks and 2, 4 and 6 months postpartum

    Reported provision of vitamin or mineral supplementation to infants from birth to 6 months in response to a prospective infant feeding questionnaire

    Time frame: birth to 6 months

07

Study locations

1 site
  • Parkdale Community Health Centre
    Toronto, Ontario M6R 3B2, Canada
08

References and documents

Publications

  • Francis J, Mildon A, Stewart S, Underhill B, Ismail S, Di Ruggiero E, Tarasuk V, Sellen DW, O'Connor DL. Breastfeeding rates are high in a prenatal community support program targeting vulnerable women and offering enhanced postnatal lactation support: a prospective cohort study. Int J Equity Health. 2021 Mar 3;20(1):71. doi: 10.1186/s12939-021-01386-6. PubMed 33658034 ↗
  • Mildon A, Francis J, Stewart S, Underhill B, Ng YM, Rousseau C, Di Ruggiero E, Dennis CL, Kiss A, O'Connor DL, Sellen DW. Associations between use of expressed human milk at 2 weeks postpartum and human milk feeding practices to 6 months: a prospective cohort study with vulnerable women in Toronto, Canada. BMJ Open. 2022 Jun 8;12(6):e055830. doi: 10.1136/bmjopen-2021-055830. PubMed 35676013 ↗

Related links

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2017 to primary completion in Oct 2020, 37 months.

Of 86 non-industry observational studies under Breast Feeding, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 54. This study's 37 months is above that.

Counting every sponsor, half of 96 studies reached it within 33 months; a quarter within 19 and three quarters within 73.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 8, 2017
First posted
Jan 17, 2018
StartActual
Aug 17, 2017
Primary completionActual
Oct 13, 2020
CompletionActual
Oct 13, 2020
Last update
May 11, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03400605
Responsible party
Daniel Sellen (Professor, University of Toronto) — Principal investigator
First posted
Jan 17, 2018
Start date
Aug 17, 2017
Primary completion
Oct 13, 2020
Completion
Oct 13, 2020
Last update
May 11, 2023

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 ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion