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Evaluating a Coparenting Breastfeeding Support Intervention (COSI)

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ClinicalTrials.gov Identifier: NCT01536119
Recruitment Status : Completed
First Posted : February 20, 2012
Results First Posted : January 24, 2014
Last Update Posted : January 24, 2014
Sponsor:
Information provided by (Responsible Party):
Cindy-Lee Dennis, University of Toronto

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Parenting
Breastfeeding
Intervention: Behavioral: Coparenting Breastfeeding Support Intervention

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment took place at on the postpartum unit of a large Toronto hospital between March 26th and July 15th 2012

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligibility determined before recruitment into trial.

Reporting Groups
  Description
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.
Usual Care Group The usual care group will receive standard postpartum care in the hospital and in the community

Participant Flow:   Overall Study
    Coparenting Breastfeeding Support Intervention   Usual Care Group
STARTED   214 [1]   214 [2] 
COMPLETED   197 [3]   200 [4] 
NOT COMPLETED   17   14 
Lost to Follow-up                17                14 
[1] (107*2= 214) (107 mothers and 107 fathers)
[2] (107*2=214) (107 mothers and 107 fathers)
[3] 104 Mothers + 93 fathers = 197 participants 3 mothers + 14 fathers = 17 did not complete the study
[4] 105 mothers + 95 fathers = 200 participants 2 mothers + 12 fathers = 14 did not complete the study



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The baseline participants consisted of 214 participants 107*2=214 107 couples per group (107 mothers and 107 fathers).

Reporting Groups
  Description
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.
Usual Care Group The usual care group will receive standard postpartum care in the hospital and in the community
Total Total of all reporting groups

Baseline Measures
   Coparenting Breastfeeding Support Intervention   Usual Care Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 214   214   428 
Age [1] 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   107   107   214 
>=65 years   0   0   0 
[1] This is a measure of maternal age only
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 33  (5.2)   33  (5.5)   33  (5.4) 
[1] Mean age of fathers in the study
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 30.4  (3.7)   30.7  (3.8)   30.6  (3.8) 
[1] Mean age of mothers in the study
Gender 
[Units: Participants]
     
Female   107   107   214 
Male   107   107   214 
Region of Enrollment [1] 
[Units: Participants]
     
Canada   107   107   214 
[1] All couples were enrolled in Canada. 214 couples with 107 couples per group


  Outcome Measures

1.  Primary:   Exclusive Breastfeeding Rate at 12 Weeks Postpartum   [ Time Frame: 12 weeks postpartum ]

2.  Secondary:   Exclusive Breastfeeding   [ Time Frame: 6 weeks ]

3.  Secondary:   Any Breastfeeding   [ Time Frame: 6 weeks ]

4.  Secondary:   Any Breastfeeding   [ Time Frame: 12 weeks ]

5.  Secondary:   Coparenting Relationship   [ Time Frame: 6 weeks ]

6.  Secondary:   Coparenting Relationship   [ Time Frame: 12 weeks postpartum ]

7.  Secondary:   Breastfeeding Support   [ Time Frame: 6 weeks ]

8.  Secondary:   Breastfeeding Support   [ Time Frame: 12 weeks ]

9.  Secondary:   Paternal Breastfeeding Self-Efficacy   [ Time Frame: 6 weeks postpartum ]

10.  Secondary:   Paternal Infant Feeding Attitude   [ Time Frame: 6 weeks postpartum ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jennifer Abbass Dick
Organization: University of Toronto
e-mail: jennifer.abbass@mail.utoronto.ca



Responsible Party: Cindy-Lee Dennis, University of Toronto
ClinicalTrials.gov Identifier: NCT01536119     History of Changes
Other Study ID Numbers: 27286
First Submitted: February 15, 2012
First Posted: February 20, 2012
Results First Submitted: July 4, 2013
Results First Posted: January 24, 2014
Last Update Posted: January 24, 2014