NCT03492411

Brief Summary

This trial will evaluate an eHealth breastfeeding co-parenting resource designed for mothers and their co-parents. Couples will be randomized to study groups and the intervention group will receive information about this resource or the control group will receive usual care. The primary outcomes will be exclusive breastfeeding at 4 and 24 weeks postpartum.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
217

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

March 25, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 10, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

2.1 years

First QC Date

February 22, 2018

Last Update Submit

March 23, 2020

Conditions

Keywords

BreastfeedingCo-parentingeHealthpatient educationfathers

Outcome Measures

Primary Outcomes (1)

  • Infant Feeding Questionnaire

    The primary outcome for this study is the rate of exclusive breastfeeding at 4 weeks postpartum. This is defined as no food or liquid other than breast milk (not even water) given to the infant and includes feeding expressed breast milk. However, under this definition of exclusive breastfeeding, undiluted drops or syrups consisting of vitamins, minerals supplements or medicines are included (Breastfeeding Committee for Canada, 2006; WHO, 2010). Exclusive breastfeeding will be determined by asking the mother what she has fed her baby in the last 7 days and what she usually feeds her baby. In this trial exclusive breastfeeding will be consistent with full breastfeeding described by Labbok and Krasovec (1990).

    4 weeks

Secondary Outcomes (6)

  • Breastfeeding Knowledge

    baseline, 2 weeks post intervention, 4 weeks postpartum

  • Breastfeeding Attitude

    baseline, 2 weeks post intervention, 4 weeks postpartum

  • Breastfeeding Self-efficacy

    baseline, 2 weeks post intervention, 4 weeks postpartum

  • Anxiety

    baseline, 2 weeks post intervention, 4 weeks postpartum, 12 weeks

  • Partner support for infant feeding

    4 and 12 weeks postpartum

  • +1 more secondary outcomes

Study Arms (2)

eHealth Intervention

EXPERIMENTAL

This group will receive information about an eHealth breastfeeding co-parenting resource. They will have a short demonstration of the site and will receive weekly emails for 6 weeks reminding them about the resource and their participation in the study.

Other: eHealth Breastfeeding Co-parenting Resource

Usual Care

NO INTERVENTION

This group will not receive any intervention. They will receive emails for 6 weeks reminding them that they are in the study.

Interventions

The eHealth breastfeeding co-parenting resource was designed using a participatory model in partnership with the target population. It contains extensive information about breastfeeding and co-parenting. The topics include not only the importance of breastfeeding and technique but also information on how to manage common issues during breastfeeding establishment as well as over the child's first years, since breastfeeding is recommended to two years and beyond. Interactive learning elements, videos, and links to additional resources are included in the resources.

eHealth Intervention

Eligibility Criteria

Age18 Years - 88 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older, over 25 weeks pregnant, planning to breastfeed, lives with co-parent who is willing to participate, first time mother or mother who has not previously breastfed,

You may not qualify if:

  • does not have access to the internet and telephone, does not reads and speaks English, does not lives in Ontario, Canada, is expecting more than one child with this pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ontario Institute of Technology

Oshawa, Ontario, L3T 4L3, Canada

Location

Related Publications (11)

  • Abbass-Dick J, Xie F, Koroluk J, Alcock Brillinger S, Huizinga J, Newport A, Goodman WM, Dennis CL. The Development and piloting of an eHealth breastfeeding resource targeting fathers and partners as co-parents. Midwifery. 2017 Jul;50:139-147. doi: 10.1016/j.midw.2017.04.004. Epub 2017 Apr 18.

    PMID: 28448858BACKGROUND
  • Abbass-Dick J, Dennis CL. Breast-feeding Coparenting Framework: A New Framework to Improve Breast-feeding Duration and Exclusivity. Fam Community Health. 2017 Jan/Mar;40(1):28-31. doi: 10.1097/FCH.0000000000000137.

    PMID: 27870751BACKGROUND
  • Dennis CL, Brown HK, Brennenstuhl S. The Postpartum Partner Support Scale: Development, psychometric assessment, and predictive validity in a Canadian prospective cohort. Midwifery. 2017 Nov;54:18-24. doi: 10.1016/j.midw.2017.07.018. Epub 2017 Jul 29.

    PMID: 28780475BACKGROUND
  • Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. doi: 10.1177/0884217503258459.

    PMID: 14649593BACKGROUND
  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PMID: 16717171BACKGROUND
  • Abbass-Dick J, Dennis CL. Maternal and paternal experiences and satisfaction with a co-parenting breastfeeding support intervention in Canada. Midwifery. 2018 Jan;56:135-141. doi: 10.1016/j.midw.2017.10.005. Epub 2017 Oct 18.

    PMID: 29101865BACKGROUND
  • Abbass-Dick J, Stern SB, Nelson LE, Watson W, Dennis CL. Coparenting breastfeeding support and exclusive breastfeeding: a randomized controlled trial. Pediatrics. 2015 Jan;135(1):102-10. doi: 10.1542/peds.2014-1416. Epub 2014 Dec 1.

    PMID: 25452653BACKGROUND
  • de la Mora, A., Russell, D. W., Dungy, C.I., Losch, M., & Dusdieker, L. (1999). The Iowa Infant Feeding Attitude Scale: Analysis of reliability and validity. Journal of Applied Social Psychology, 29, 2362-2380.

    BACKGROUND
  • Labbok M, Krasovec K. Toward consistency in breastfeeding definitions. Stud Fam Plann. 1990 Jul-Aug;21(4):226-30.

    PMID: 2219227BACKGROUND
  • World Health Oraniazation. (2010). Indicators for Assessing Infant and Child Feeding Practices: part two measurement. Malta: WHO

    BACKGROUND
  • Breastfeeding Committee for Canada. (2006). Breastfeeding Definitions and Data Collection Periods.

    BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Jennifer Abbass-Dick

    Ms.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessor will be blinded to group allocation. Follow up data will be collected via online survey or telephone interview with survey questions. Mode of data collection will depend on participant preference
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 150 couples will be randomized to group allocation, intervention group or control group with use sequentially numbered opaque envelopes
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 22, 2018

First Posted

April 10, 2018

Study Start

March 25, 2018

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations