Clinical trial NCT03400605: Parkdale Infant Nutrition Security Targeted Evaluation Project: Infant Feeding
Official title: Parkdale Infant Nutrition Security Targeted Evaluation Project (PINSTEP): Formative Research (Objective 3-Infant Feeding)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breastfeeding
Breastfeeding, Exclusive
Infant Nutrition
Vulnerable Population
Complementary Feeding
Food Security
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 203
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Exclusive breastfeeding as assessed by responses to an infant feeding questionnaire
timeFrame: birth to 6 months postpartum
Secondary outcomes:
measure: Breastfeeding initiation as assessed by responses to an infant feeding questionnaire administered at 2 weeks postpartum
timeFrame: birth to 2 weeks postpartum
measure: Breastfeeding duration as assessed by responses to an infant feeding questionnaire administered at 2 weeks and 2, 4 and 6 months postpartum
timeFrame: birth to 6 months
measure: Introduction of complementary foods as assessed by responses to an infant feeding questionnaire administered at 2 weeks and 2, 4 and 6 months postpartum
timeFrame: birth to 6 months
measure: 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
timeFrame: birth to 6 months
measure: Vitamin and mineral supplementation as assessed by responses to an infant feeding questionnaire administered at 2 weeks and 2, 4 and 6 months postpartum
timeFrame: birth to 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Parkdale Community Health Centre
state: Ontario
Study officials:
affiliation: University of Toronto
name: Jane Francis, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.