Evaluating a Coparenting Breastfeeding Support Intervention

Breastfeeding Clinical Trial

— COSI  

Official title:

Evaluating the Effectiveness of a Coparenting Breastfeeding Support Intervention on Exclusive Breastfeeding Rates at 12 Weeks Postpartum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01536119
• Other study ID #: 27286
• Status: Completed
• Phase: N/A
• First received: February 15, 2012
• Last updated: December 18, 2013
• Start date: February 2012
• Est. completion date: November 2012

Study information

• Verified date: December 2013
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 428
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breastfeeding
• Parenting

Intervention

Behavioral:
• Coparenting Breastfeeding Support Intervention
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.

Locations

Country	Name	City	State
Canada	North York General Hospital	North York	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Exclusive Breastfeeding	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).	6 weeks	No
Secondary	Any Breastfeeding	Any breastfeeding was measured by asking the mother what she had fed her infant in the last 24 hours and what she usually feeds her baby. Any breastfeeding indicated the mother was breastfeeding or providing her infant with expressed breastmilk and this included combined feeding with formula. If the mother responded she was only formula feeding this indicated the infant she was not doing any breastfeeding or being fed any breast milk.	6 weeks	No
Secondary	Any Breastfeeding	Any breastfeeding was measured by asking the mother what she had fed her infant in the last 24 hours and what she usually feeds her baby. Any breastfeeding indicated the mother was breastfeeding or providing her infant with expressed breastmilk and this included combined feeding with formula. If the mother responded she was only formula feeding this indicated the infant she was not doing any breastfeeding or being fed any breast milk.	12 weeks	No
Secondary	Coparenting Relationship	Coparenting is the degree to which parents work together to achieve parenting goals. This will be measured using Feinberg, Brown and Kan (2010) Coparenting Relationship Scale (CRS) Brief Form. There are 14 items in total in this tool. There is a 7 point response scale ranging from 0 - 6. The total score ranges from 0 - 84. Negative items are reversed and the higher scores indicate positive coparenting.	6 weeks	No
Secondary	Coparenting Relationship	Coparenting is the degree to which parents work together to achieve parenting goals. This will be measured using Feinberg, Brown and Kan (2010) Coparenting Relationship Scale (CRS). There are 35 items in total in this tool. There is a 7 point response scale ranging from 0 to 6. Total scores range from 0 - 210. Negative items are reversed. Higher scores indicated positive coparenting.	12 weeks postpartum	No
Secondary	Breastfeeding Support	Breastfeeding support is defined as the appraisal, emotional, informational and instrumental support the mother receives from her partner. This component of coparenting will be measured using the Postpartum Partner Support Scale (PPSS), which is a 24-item self-report instrument. The items are rated on a 4 point scale to produce a summative score ranging from 25-100. Two negative items are reversed scored and the higher scores indicate higher levels of postpartum-specific partner support.	6 weeks	No
Secondary	Breastfeeding Support	Breastfeeding support is defined as the appraisal, emotional, informational and instrumental support the mother receives from her partner. This component of coparenting will be measured using the Postpartum Partner Support Scale (PPSS), which is a 24-item self-report instrument. The items are rated on a 4 point scale to produce a summative score ranging from 25-100. Two negative items are reversed scored and the higher scores indicate higher levels of postpartum-specific partner support.	12 weeks	No
Secondary	Paternal Breastfeeding Self-Efficacy	Breastfeeding Self-Efficacy Scale- Short Form will be adapted and used to assess fathers' confidence with assisting their partner with breastfeeding.; This instrument has 14 items, with responses ranging from 1-5. The total scores range from 14-70 with higher scores indicating higher breastfeeding self-efficacy.	6 weeks postpartum	No
Secondary	Paternal Infant Feeding Attitude	Paternal infant feeding attitude will be assessed using the Iowa Infant Feeding Attitude Scale. This scale consist of 17 items with a five point response range (1-5). The total scores range from 17-85. Negative items were reverse scored. Lower scores indicate a preference for formula feeding, while higher scores indicating a preference for breastfeeding.	6 weeks postpartum	No