NCT01536119

Brief Summary

The purpose of this trial is to evaluate the effectiveness of a Coparenting Breastfeeding Support Intervention with first time parents on exclusive breastfeeding rates at 12 weeks postpartum. Partner support and the coparenting relationship will also be evaluated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
428

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 20, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 24, 2014

Completed
Last Updated

January 24, 2014

Status Verified

December 1, 2013

Enrollment Period

8 months

First QC Date

February 15, 2012

Results QC Date

July 4, 2013

Last Update Submit

December 18, 2013

Conditions

ParentingBreastfeeding

Keywords

BreastfeedingCoparentingInfant feedingFathers' supportBreastfeeding supportBreastfeeding support interventionclinical trial

Outcome Measures

Primary Outcomes (1)

  • Exclusive Breastfeeding Rate at 12 Weeks Postpartum

    Exclusive breastfeeding will be determined by asking the mother what she has fed her baby in the last 24 hrs and what she usually feeds her baby. This is consistent with the World Health Organizations definition of exclusive breastfeeding and full breastfeeding described by Labbok and Krasovec (1990). This is defined as no food or liquid other than breast milk given to the infant; however, undiluted drops or syrups consisting of vitamins, minerals supplements or medicines are included (Breastfeeding Committee for Canada, 2006; WHO, 2010).

    12 weeks postpartum

Secondary Outcomes (9)

  • Exclusive Breastfeeding

    6 weeks

  • Any Breastfeeding

    6 weeks

  • Any Breastfeeding

    12 weeks

  • Coparenting Relationship

    6 weeks

  • Coparenting Relationship

    12 weeks postpartum

  • +4 more secondary outcomes

Study Arms (2)

Coparenting Breastfeeding Support Intervention

EXPERIMENTAL

The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.

Behavioral: Coparenting Breastfeeding Support Intervention

Usual Care Group

NO INTERVENTION

The usual care group will receive standard postpartum care in the hospital and in the community

Interventions

Coparenting Breastfeeding Support InterventionBEHAVIORAL

The intervention group will receive standard care offered to breastfeeding women in the hospital and community with the addition of a multifaceted coparenting breastfeeding support intervention, which will include an in hospital discussion, a video, workbook, breastfeeding booklet, and access to a secure website. Additionally, two follow-up phone calls will be made at 1 and 4 weeks postpartum. This intervention has been designed with coparenting elements and contains extensive breastfeeding information.

Also known as: Other Names:, Coparenting Group
Coparenting Breastfeeding Support Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • singleton birth (vaginal and cesarean births)
  • term infant (37-42 weeks gestation)
  • speaks and reads English
  • years of age or older
  • parents living in the same home, father (the breastfeeding woman's male partner) jointly responsible for the infant.

You may not qualify if:

  • sharing a hospital room with a study participant
  • infants or maternal medical problems that interfere with breastfeeding (eg. infant with cleft palate or maternal previous breast surgery)
  • midwifery patient
  • infant not discharged home with mother
  • mother is pumping milk but not breastfeeding
  • mother does not have access to the internet
  • mother does not have a telephone.
  • father not available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North York General Hospital

North York, Ontario, M2K 1E1, Canada

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Results Point of Contact

Title
Jennifer Abbass Dick
Organization
University of Toronto
jennifer.abbass@mail.utoronto.ca

Study Officials

  • Cindy-Lee Dennis, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Lawrence S. Bloomberg Faculty of Nursing

Study Record Dates

First Submitted

February 15, 2012

First Posted

February 20, 2012

Study Start

February 1, 2012

Primary Completion

October 1, 2012

Study Completion

November 1, 2012

Last Updated

January 24, 2014

Results First Posted

January 24, 2014

Record last verified: 2013-12

Locations

CA(1)