Breastfeeding, Parenting
Conditions
Keywords
Breastfeeding, Coparenting, Infant feeding, Fathers' support, Breastfeeding support, Breastfeeding support intervention, clinical trial
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.
Interventions
BEHAVIORALCoparenting 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.
Sponsors
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exclusive Breastfeeding Rate at 12 Weeks Postpartum | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Any Breastfeeding | 6 weeks | 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. |
| Coparenting Relationship | 6 weeks | 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. |
| Exclusive Breastfeeding | 6 weeks | 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). |
| Paternal Breastfeeding Self-Efficacy | 6 weeks postpartum | 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. |
| Paternal Infant Feeding Attitude | 6 weeks postpartum | 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. |
| Breastfeeding Support | 6 weeks | 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. |
Countries
Canada
Participant flow
Recruitment details
Recruitment took place at on the postpartum unit of a large Toronto hospital between March 26th and July 15th 2012
Pre-assignment details
Eligibility determined before recruitment into trial.
Participants by arm
| Arm | Count |
|---|---|
| Coparenting Breastfeeding Support Intervention 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. | 214 |
| Usual Care Group The usual care group will receive standard postpartum care in the hospital and in the community | 214 |
| Total | 428 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 17 | 14 |
Baseline characteristics
| Characteristic | Coparenting Breastfeeding Support Intervention | Total | Usual Care Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 participants | 0 participants | 0 participants |
| Age, Categorical >=65 years | 0 participants | 0 participants | 0 participants |
| Age, Categorical Between 18 and 65 years | 107 participants | 214 participants | 107 participants |
| Age, Continuous | 33 years STANDARD_DEVIATION 5.2 | 30.6 years STANDARD_DEVIATION 3.8 | 30.7 years STANDARD_DEVIATION 3.8 |
| Region of Enrollment Canada | 107 participants | 214 participants | 107 participants |
| Sex: Female, Male Female | 107 Participants | 214 Participants | 107 Participants |
| Sex: Female, Male Male | 107 Participants | 214 Participants | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 214 | 0 / 214 |
| serious Total, serious adverse events | 0 / 214 | 0 / 214 |
Outcome results
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).
Time frame: 12 weeks postpartum
Population: Analysis population included only mothers
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Coparenting Breastfeeding Support Intervention | Exclusive Breastfeeding Rate at 12 Weeks Postpartum | 70 percentage of participants |
| Usual Care Group | Exclusive Breastfeeding Rate at 12 Weeks Postpartum | 63 percentage of participants |
Comparison: Power analysis was conducted to a 15 % increase in exclusive breastfeeding rates (from 52% to 67%) with 80% power and an alpha of 0.05. A 25% attrition rate waas added. 107 couples were needed per group. Intention to treat analysis conducted.~Exclusive breastfeeding at 12 weeksp-value: 0.2795% CI: [0.91, 1.38]Chi-squared
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.
Time frame: 6 weeks
Population: Analysis population included only mothers
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Coparenting Breastfeeding Support Intervention | Any Breastfeeding | 102 participants |
| Usual Care Group | Any Breastfeeding | 94 participants |
p-value: 0.0695% CI: [1, 1.13]Fisher Exact
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.
Time frame: 12 weeks
Population: Analysis population included only mothers
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Coparenting Breastfeeding Support Intervention | Any Breastfeeding | 100 participants |
| Usual Care Group | Any Breastfeeding | 92 participants |
p-value: 0.0295% CI: [1.01, 1.19]Chi-squared
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.
Time frame: 12 weeks
Population: Analysis population included only mothers who completed the scale at 12 weeks postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coparenting Breastfeeding Support Intervention | Breastfeeding Support | 86.6 units on a scale | Standard Deviation 11.7 |
| Usual Care Group | Breastfeeding Support | 83.6 units on a scale | Standard Deviation 14.4 |
p-value: 0.21Wilcoxon (Mann-Whitney)
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.
Time frame: 6 weeks
Population: Analysis population included only mothers who completed the scale at 6 weeks postpartum.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coparenting Breastfeeding Support Intervention | Breastfeeding Support | 88.0 units on a scale | Standard Deviation 10.9 |
| Usual Care Group | Breastfeeding Support | 85.6 units on a scale | Standard Deviation 10.5 |
p-value: 0.12t-test, 2 sided
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.
Time frame: 6 weeks
Population: Analysis population included only mothers who completed the questionnaire at 6 weeks postpartum.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coparenting Breastfeeding Support Intervention | Coparenting Relationship | 73.01 units on a scale | Standard Deviation 9.8 |
| Usual Care Group | Coparenting Relationship | 71.3 units on a scale | Standard Deviation 10.6 |
Comparison: Brief scale usedp-value: 0.25Wilcoxon (Mann-Whitney)
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.
Time frame: 12 weeks postpartum
Population: Analysis population included only mothers who completed the scale at 12 weeks postpartum.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coparenting Breastfeeding Support Intervention | Coparenting Relationship | 179.9 units on a scale | Standard Deviation 27.4 |
| Usual Care Group | Coparenting Relationship | 174.9 units on a scale | Standard Deviation 27.4 |
p-value: 0.29Wilcoxon (Mann-Whitney)
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).
Time frame: 6 weeks
Population: Analysis population included only mothers
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Coparenting Breastfeeding Support Intervention | Exclusive Breastfeeding | 75 percentage of participants |
| Usual Care Group | Exclusive Breastfeeding | 62 percentage of participants |
p-value: 0.0995% CI: [0.98, 1.44]Chi-squared
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.
Time frame: 6 weeks postpartum
Population: Analysis population included fathers completed the scale and who had infants breastfeeding at 6 weeks postpartum (fathers of infants fed expressed breastmilk were not included).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coparenting Breastfeeding Support Intervention | Paternal Breastfeeding Self-Efficacy | 55.9 units on a scale | Standard Deviation 8.4 |
| Usual Care Group | Paternal Breastfeeding Self-Efficacy | 53.1 units on a scale | Standard Deviation 11.2 |
p-value: 0.06t-test, 2 sided
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.
Time frame: 6 weeks postpartum
Population: Analysis population included only fathers who completed the scale at 6 weeks postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coparenting Breastfeeding Support Intervention | Paternal Infant Feeding Attitude | 62.1 units on a scale | Standard Deviation 8.1 |
| Usual Care Group | Paternal Infant Feeding Attitude | 61.2 units on a scale | Standard Deviation 6.7 |
p-value: 0.43t-test, 2 sided