Clinical trial NCT01536119: Evaluating a Coparenting Breastfeeding Support Intervention
Official title: Evaluating the Effectiveness of a Coparenting Breastfeeding Support Intervention on Exclusive Breastfeeding Rates at 12 Weeks Postpartum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenting
Breastfeeding
Keywords: Breastfeeding
Coparenting
Infant feeding
Fathers' support
Breastfeeding support
Breastfeeding support intervention
clinical trial
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2012-02-20
Enrollment: 428
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Breastfeeding is the recommended infant feeding method by leading health authorities. This recommendation is based on the many health benefits breastfeeding provides to both women and their infants. Breastfeeding rates in Canada, however, are suboptimal, with nearly half of mothers discontinuing exclusive breastfeeding in the first three months and less than twenty-five percent of mothers meeting the recommendation of exclusive breastfeeding to six months.

There are many factors associated with the premature cessation of exclusive breastfeeding. They include demographic, biological, psychosocial, and social factors. Some of these factors are not modifiable, such as age, social status, and education level, as they are not amenable to an intervention. One possible modifiable factor, which may assist women in overcoming breastfeeding difficulties, is fathers' support with breastfeeding. Fathers' favourable attitude and support of breastfeeding positively impacts breastfeeding initiation, duration, and exclusivity. Research on ways to assist fathers in providing support for breastfeeding is needed. The ways in which fathers can provide effective support can best be determined through intervention studies designed to increase fathers' supportive behaviour towards breastfeeding. Specifically, a coparenting framework to guide such interventions would be optimal as coparenting teaches parents to work in partnership towards positive child health outcomes. The purpose of this proposed randomized controlled trial is to evaluate the effects of a coparenting breastfeeding support intervention, delivered to primiparous breastfeeding mothers and the infants' fathers (the breastfeeding woman's male partner, who is jointly responsible for the child). It is hypothesized that this intervention will increase exclusive breastfeeding at 12 weeks postpartum. The secondary outcomes will be breastfeeding duration, perceived breastfeeding support, and coparenting at 6 and 12 weeks. Paternal breastfeeding self-efficacy and infant feeding attitude will be assessed at 6 weeks postpartum.

Participants will include first-time breastfeeding women and the infants' fathers who have singleton births and full term healthy infants. Eligible parents who consent to participate will be randomized into either the intervention group or the control group. The control group will receive standard postpartum care, which is routine care in the hospital and community related to breastfeeding. The intervention group will receive standard postpartum care, plus a multifaceted support intervention that includes: (1) a professional-based in-hospital visit in the first two days postpartum that uses a take-home workbook, breastfeeding booklet, and video, (2) two follow-up emails in the first and third week postpartum, (3) one telephone call to the mother at two weeks, and (4) access to a secure study website for a three month period. All of the components in this intervention will contain extensive information on coparenting and breastfeeding. Follow-up data will be collected by the method chosen by participants, either by web-based survey or telephone interview. This data will be collected by a research assistant blinded to group allocation and data collection points will be at 6 and 12 week postpartum.

The results of this study will be of interest to health care professionals who work with breastfeeding women and their families, as well as policy makers designing programs to meet the needs of childbearing families.

Eligibility criteria: Inclusion Criteria:

* The target population for the study will be all primiparous breastfeeding women on the postpartum unit who meet the following inclusion criteria:

  1. singleton birth (vaginal and cesarean births)
  2. term infant (37-42 weeks gestation)
  3. speaks and reads English
  4. 18 years of age or older
  5. parents living in the same home, father (the breastfeeding woman's male partner) jointly responsible for the infant.

Exclusion Criteria:

* The exclusion criteria will include:

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

Primary outcomes:
measure: Exclusive Breastfeeding Rate at 12 Weeks Postpartum
timeFrame: 12 weeks postpartum
Secondary outcomes:
measure: Exclusive Breastfeeding
timeFrame: 6 weeks
measure: Any Breastfeeding
timeFrame: 6 weeks
measure: Any Breastfeeding
timeFrame: 12 weeks
measure: Coparenting Relationship
timeFrame: 6 weeks
measure: Coparenting Relationship
timeFrame: 12 weeks postpartum
measure: Breastfeeding Support
timeFrame: 6 weeks
measure: Breastfeeding Support
timeFrame: 12 weeks
measure: Paternal Breastfeeding Self-Efficacy
timeFrame: 6 weeks postpartum
measure: Paternal Infant Feeding Attitude
timeFrame: 6 weeks postpartum
Other outcomes:
Locations:
city: North York
country: Canada
facility: North York General Hospital
state: Ontario
Study officials:
affiliation: University of Toronto
name: Cindy-Lee Dennis, PhD
role: PRINCIPAL_INVESTIGATOR
References: