ParentingCOSINCT01536119
Evaluating a Coparenting Breastfeeding Support Intervention
A study testing Coparenting Breastfeeding Support Intervention in people with Parenting and Breastfeeding, run by University of Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parenting, Breastfeeding
- What is being tested?
- Coparenting Breastfeeding Support Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 428 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to Nov 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The target population for the study will be all primiparous breastfeeding women on the postpartum unit who meet the following inclusion criteria:
- singleton birth (vaginal and cesarean births)
- term infant (37-42 weeks gestation)
- speaks and reads English
- 18 years of age or older
- parents living in the same home, father (the breastfeeding woman's male partner) jointly responsible for the infant.
Who cannot join
- The exclusion criteria will include:
- 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
Show all 9Show fewer
- mother does not have access to the internet
- mother does not have a telephone.
- father not available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effectiveness of a Coparenting Breastfeeding Support Intervention on Exclusive Breastfeeding Rates at 12 Weeks Postpartum
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.
Read the 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.
- Conditions
- Parenting, Breastfeeding
- Being tested
- Coparenting Breastfeeding Support Intervention
- Keywords
- Breastfeeding, Coparenting, Infant feeding, Fathers' support, Breastfeeding support, Breastfeeding support intervention, clinical trial
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coparenting Breastfeeding Support InterventionBehavioural
Also called Other Names:, Coparenting Group
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks postpartum
Secondary outcomes (9)
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).
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 12 weeks
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.
Measured: 6 weeks
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.
Measured: 12 weeks postpartum
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.
Measured: 6 weeks
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.
Measured: 12 weeks
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.
Measured: 6 weeks postpartum
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.
Measured: 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionOct 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ParentingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 428 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cindy-Lee Dennis, University of Toronto
- Investigators
- Cindy-Lee Dennis, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536119
- Sponsor's protocol ID
- 27286
- Acronym
- COSI
- Status last verified
- Dec 2013
- First submitted
- 15 Feb 2012
- Last updated
- 24 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of a Coparenting Breastfeeding Support Intervention on Exclusive Breastfeeding Rates at 12 Weeks Postpartum
- ClinicalTrials.gov ID
- NCT01536119
- Acronym / sponsor ID
- COSI / 27286
- Conditions
- Parenting, Breastfeeding
- Keywords
- Breastfeeding, Coparenting, Infant feeding, Fathers' support, Breastfeeding support, Breastfeeding support intervention, clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 428 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 20 Feb 2012 (estimated)
- Results
- Posted 24 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coparenting Breastfeeding Support Intervention | Experimental | Behavioral: Coparenting Breastfeeding Support InterventionThe 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. |
| Usual Care Group | No intervention | –The usual care group will receive standard postpartum care in the hospital and in the community |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The target population for the study will be all primiparous breastfeeding women on the postpartum unit who meet the following inclusion criteria:
Key exclusion criteria (9 listed)
- The exclusion criteria will include:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coparenting Breastfeeding Support InterventionAlso: Other Names:, Coparenting GroupThe 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. | Behavioural | Coparenting Breastfeeding Support Intervention |
Primary outcome
Exclusive Breastfeeding Rate at 12 Weeks Postpartum
Time frame: 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).
9 secondary outcomes
Exclusive Breastfeeding
Time frame: 6 weeks
Any Breastfeeding
Time frame: 6 weeks
Any Breastfeeding
Time frame: 12 weeks
Coparenting Relationship
Time frame: 6 weeks
Coparenting Relationship
Time frame: 12 weeks postpartum
Breastfeeding Support
Time frame: 6 weeks
Breastfeeding Support
Time frame: 12 weeks
Paternal Breastfeeding Self-Efficacy
Time frame: 6 weeks postpartum
Paternal Infant Feeding Attitude
Time frame: 6 weeks postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy-Lee Dennis, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coparenting Breastfeeding Support Intervention in people with Parenting and Breastfeeding, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exclusive Breastfeeding Rate at 12 Weeks Postpartum (time frame: 12 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2014.