PINSTEP-3: Parkdale Infant Nutrition Security Targeted Evaluation Project: Infant Feeding

• Sponsor: University of Toronto (Other)
• Overall Status: Completed
• CT.gov ID: NCT03400605
• Collaborator: (none)
• Enrollment: 203
• Location: 1
• Actual Duration (Months): 37.9
• Patients Per Site Per Month: 5.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breastfeeding; Breastfeeding, Exclusive; Infant Nutrition; Vulnerable Population; Complementary Feeding; Food Security	Other: Infant feeding questionnaire

Study Design

• Study Type: Observational
• Actual Enrollment: 203 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Parkdale Infant Nutrition Security Targeted Evaluation Project (PINSTEP): Formative Research (Objective 3-Infant Feeding)
• Actual Study Start Date: Aug 17, 2017
• Actual Primary Completion Date: Oct 13, 2020
• Actual Study Completion Date: Oct 13, 2020

Arms and Interventions

Arm	Intervention/Treatment
Program Clients Parkdale Parents' Primary Prevention Project (5P's) clients	Other: Infant feeding questionnaire; Prospective infant feeding questionnaire administered over the telephone or in-person at 2 weeks and at 2, 4 and 6 months postpartum

Outcome Measures

Primary Outcome Measures

1. Exclusive breastfeeding as assessed by responses to an infant feeding questionnaire [birth to 6 months postpartum]

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

Secondary Outcome Measures

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

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

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

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

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 [birth to 6 months]

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

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 [birth to 6 months]

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

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 [birth to 6 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Parkdale Community Health Centre	Toronto	Ontario	Canada	M6R 3B2

Sponsors and Collaborators

• University of Toronto

Investigators

• Principal Investigator: Jane Francis, MSc, University of Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daniel Sellen, Professor, University of Toronto
• ClinicalTrials.gov Identifier: NCT03400605
• Other Study ID Numbers: 34482-3
• First Posted: Jan 17, 2018
• Last Update Posted: Feb 25, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 25, 2021