BreastfeedingPINSTEP-3NCT03400605
Parkdale Infant Nutrition Security Targeted Evaluation Project: Infant Feeding
An observational study of Breastfeeding and Breastfeeding, Exclusive, 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
- Breastfeeding, Breastfeeding, Exclusive, Infant Nutrition
- What is being tested?
- Infant feeding questionnaire
- How many people
- 203 participants
- Where
- 1 siteCanada
- Study dates
- 17 Aug 2017to 13 Oct 2020
- 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) at Parkdale Community Health Centre in Toronto, Ontario, Canada.
Who may be able to join
- Enrolled in Parkdale Parents' Primary Prevention Project (5P's) prenatally
- Enrolled prenatally in 5P's as of August 17, 2017 onwards
Who cannot join
- 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
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 3-Infant Feeding)
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.
- Conditions
- Breastfeeding, Breastfeeding, Exclusive, Infant Nutrition, Vulnerable Population, Complementary Feeding, Food Security
- Being tested
- Infant feeding questionnaire
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant feeding questionnaireOther
Prospective infant feeding questionnaire administered over the telephone or in-person at 2 weeks and at 2, 4 and 6 months postpartum
| Study group | Role | What they receive |
|---|---|---|
| Program Clients | Parkdale Parents' Primary Prevention Project (5P's) clients Receives: Other: Infant feeding questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: birth to 6 months postpartum
Secondary outcomes (5)
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
Measured: birth to 2 weeks postpartum
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
Measured: birth to 6 months
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
Measured: birth to 6 months
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
Measured: birth to 6 months
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
Measured: birth to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start17 Aug 2017
- Primary completion13 Oct 2020
- Study completion13 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies 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
- Prospective
- Enrolment
- 203 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
- NCT03400605
- Sponsor's protocol ID
- 34482-3
- Acronym
- PINSTEP-3
- Status last verified
- May 2023
- First submitted
- 8 Dec 2017
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 33658034Mildon 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
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. 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 3-Infant Feeding)
- ClinicalTrials.gov ID
- NCT03400605
- Acronym / sponsor ID
- PINSTEP-3 / 34482-3
- Conditions
- Breastfeeding, Breastfeeding, Exclusive, Infant Nutrition, Vulnerable Population, Complementary Feeding, Food Security
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 17 Aug 2017 (actual)
- Primary completion
- 13 Oct 2020 (actual)
- Study completion
- 13 Oct 2020 (actual)
- First posted
- 17 Jan 2018 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Program Clients | – | Other: Infant feeding questionnaireParkdale 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) at Parkdale Community Health Centre in Toronto, Ontario, Canada.
Key inclusion criteria (2 listed)
- Enrolled in Parkdale Parents' Primary Prevention Project (5P's) prenatally
- Enrolled prenatally in 5P's as of August 17, 2017 onwards
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Infant feeding questionnaireProspective infant feeding questionnaire administered over the telephone or in-person at 2 weeks and at 2, 4 and 6 months postpartum | Other | Program Clients |
Primary outcome
Exclusive breastfeeding as assessed by responses to an infant feeding questionnaire
Time frame: birth to 6 months postpartum
Reported exclusive breastfeeding from birth to 6 months in response to a prospective infant feeding questionnaire
5 secondary outcomes
Breastfeeding initiation as assessed by responses to an infant feeding questionnaire administered at 2 weeks postpartum
Time frame: birth to 2 weeks postpartum
Breastfeeding duration as assessed by responses to an infant feeding questionnaire administered at 2 weeks and 2, 4 and 6 months postpartum
Time frame: birth to 6 months
Introduction of complementary foods as assessed by responses to an infant feeding questionnaire administered at 2 weeks and 2, 4 and 6 months postpartum
Time frame: birth to 6 months
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
Time frame: birth to 6 months
Vitamin and mineral supplementation as assessed by responses to an infant feeding questionnaire administered at 2 weeks and 2, 4 and 6 months postpartum
Time frame: birth to 6 months
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 11 May 2023.
- Results publication: PubMed 33658034Francis 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.
- Derived from this study: PubMed 35676013Mildon 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.
- Related InfoLink provided by the sponsor.
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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 Breastfeeding, Exclusive, 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 11 May 2023. 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?
Exclusive breastfeeding as assessed by responses to an infant feeding questionnaire (time frame: birth to 6 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 NCT03400605, which also lists 2 linked publications.
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 11 May 2023.