Breastfeeding Clinical Trial
— PINSTEP-3Official title:
Parkdale Infant Nutrition Security Targeted Evaluation Project (PINSTEP): Formative Research (Objective 3-Infant Feeding)
NCT number | NCT03400605 |
Other study ID # | 34482-3 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 17, 2017 |
Est. completion date | October 13, 2020 |
Verified date | May 2023 |
Source | University of Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 203 |
Est. completion date | October 13, 2020 |
Est. primary completion date | October 13, 2020 |
Accepts healthy volunteers | |
Gender | Female |
Age group | N/A and older |
Eligibility | 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: - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Parkdale Community Health Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Toronto |
Canada,
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 p — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | birth to 6 months postpartum | |
Secondary | 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 | birth to 2 weeks postpartum | |
Secondary | 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 | birth to 6 months | |
Secondary | 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 | birth to 6 months | |
Secondary | 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 | birth to 6 months | |
Secondary | 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 | birth to 6 months |
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