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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
Enrollment 428

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.
Arm/Group Title Coparenting Breastfeeding Support Intervention Usual Care Group
Hide Arm/Group Description 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. The usual care group will receive standard postpartum care in the hospital and in the community
Period Title: Overall Study
Started 214 [1] 214 [2]
Completed 197 [3] 200 [4]
Not Completed 17 14
Reason Not Completed
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
Arm/Group Title Coparenting Breastfeeding Support Intervention Usual Care Group Total
Hide Arm/Group Description 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. The usual care group will receive standard postpartum care in the hospital and in the community Total of all reporting groups
Overall Number of Baseline Participants 214 214 428
Hide Baseline Analysis Population Description
The baseline participants consisted of 214 participants 107*2=214 107 couples per group (107 mothers and 107 fathers).
Age, Categorical   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 214 participants 214 participants 428 participants
<=18 years 0 0 0
Between 18 and 65 years 107 107 214
>=65 years 0 0 0
[1]
Measure Description: This is a measure of maternal age only
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 214 participants 214 participants 428 participants
33  (5.2) 33  (5.5) 33  (5.4)
[1]
Measure Description: Mean age of fathers in the study
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 214 participants 214 participants 428 participants
30.4  (3.7) 30.7  (3.8) 30.6  (3.8)
[1]
Measure Description: Mean age of mothers in the study
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 214 participants 214 participants 428 participants
Female
107
  50.0%
107
  50.0%
214
  50.0%
Male
107
  50.0%
107
  50.0%
214
  50.0%
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 214 participants 214 participants 428 participants
107 107 214
[1]
Measure Description: All couples were enrolled in Canada. 214 couples with 107 couples per group
1.Primary Outcome
Title Exclusive Breastfeeding Rate at 12 Weeks Postpartum
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included only mothers
Arm/Group Title Coparenting Breastfeeding Support Intervention Usual Care Group
Hide Arm/Group Description:
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.
The usual care group will receive standard postpartum care in the hospital and in the community
Overall Number of Participants Analyzed 104 105
Measure Type: Number
Unit of Measure: percentage of participants
70 63
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Coparenting Breastfeeding Support Intervention, Usual Care Group
Comments

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 weeks

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
0.91 to 1.38
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Exclusive Breastfeeding
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included only mothers
Arm/Group Title Coparenting Breastfeeding Support Intervention Usual Care Group
Hide Arm/Group Description:
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.
The usual care group will receive standard postpartum care in the hospital and in the community
Overall Number of Participants Analyzed 104 102
Measure Type: Number
Unit of Measure: percentage of participants
75 62
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Coparenting Breastfeeding Support Intervention, Usual Care Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.19
Confidence Interval 95%
0.98 to 1.44
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Any Breastfeeding
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included only mothers
Arm/Group Title Coparenting Breastfeeding Support Intervention Usual Care Group
Hide Arm/Group Description:
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.
The usual care group will receive standard postpartum care in the hospital and in the community
Overall Number of Participants Analyzed 104 102
Measure Type: Number
Unit of Measure: participants
102 94
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Coparenting Breastfeeding Support Intervention, Usual Care Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.06
Confidence Interval 95%
1.00 to 1.13
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Any Breastfeeding
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included only mothers
Arm/Group Title Coparenting Breastfeeding Support Intervention Usual Care Group
Hide Arm/Group Description:
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.
The usual care group will receive standard postpartum care in the hospital and in the community
Overall Number of Participants Analyzed 104 105
Measure Type: Number
Unit of Measure: participants
100 92
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Coparenting Breastfeeding Support Intervention, Usual Care Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.10
Confidence Interval 95%
1.01 to 1.19
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Coparenting Relationship
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included only mothers who completed the questionnaire at 6 weeks postpartum.
Arm/Group Title Coparenting Breastfeeding Support Intervention Usual Care Group
Hide Arm/Group Description:
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.
The usual care group will receive standard postpartum care in the hospital and in the community
Overall Number of Participants Analyzed 98 91
Mean (Standard Deviation)
Unit of Measure: units on a scale
73.01  (9.8) 71.3  (10.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Coparenting Breastfeeding Support Intervention, Usual Care Group
Comments Brief scale used
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Coparenting Relationship
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included only mothers who completed the scale at 12 weeks postpartum.
Arm/Group Title Coparenting Breastfeeding Support Intervention Usual Care Group
Hide Arm/Group Description:
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.
The usual care group will receive standard postpartum care in the hospital and in the community
Overall Number of Participants Analyzed 100 96
Mean (Standard Deviation)
Unit of Measure: units on a scale
179.9  (27.4) 174.9  (27.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Coparenting Breastfeeding Support Intervention, Usual Care Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Secondary Outcome
Title Breastfeeding Support
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included only mothers who completed the scale at 6 weeks postpartum.
Arm/Group Title Coparenting Breastfeeding Support Intervention Usual Care Group
Hide Arm/Group Description:
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.
The usual care group will receive standard postpartum care in the hospital and in the community
Overall Number of Participants Analyzed 98 91
Mean (Standard Deviation)
Unit of Measure: units on a scale
88.0  (10.9) 85.6  (10.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Coparenting Breastfeeding Support Intervention, Usual Care Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Breastfeeding Support
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included only mothers who completed the scale at 12 weeks postpartum
Arm/Group Title Coparenting Breastfeeding Support Intervention Usual Care Group
Hide Arm/Group Description:
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.
The usual care group will receive standard postpartum care in the hospital and in the community
Overall Number of Participants Analyzed 100 96
Mean (Standard Deviation)
Unit of Measure: units on a scale
86.6  (11.7) 83.6  (14.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Coparenting Breastfeeding Support Intervention, Usual Care Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Secondary Outcome
Title Paternal Breastfeeding Self-Efficacy
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Coparenting Breastfeeding Support Intervention Usual Care Group
Hide Arm/Group Description:
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.
The usual care group will receive standard postpartum care in the hospital and in the community
Overall Number of Participants Analyzed 93 95
Mean (Standard Deviation)
Unit of Measure: units on a scale
55.9  (8.4) 53.1  (11.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Coparenting Breastfeeding Support Intervention, Usual Care Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title Paternal Infant Feeding Attitude
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included only fathers who completed the scale at 6 weeks postpartum
Arm/Group Title Coparenting Breastfeeding Support Intervention Usual Care Group
Hide Arm/Group Description:
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.
The usual care group will receive standard postpartum care in the hospital and in the community
Overall Number of Participants Analyzed 93 95
Mean (Standard Deviation)
Unit of Measure: units on a scale
62.1  (8.1) 61.2  (6.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Coparenting Breastfeeding Support Intervention, Usual Care Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 3 months data collection time period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Coparenting Breastfeeding Support Intervention Usual Care Group
Hide Arm/Group Description 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. The usual care group will receive standard postpartum care in the hospital and in the community
All-Cause Mortality
Coparenting Breastfeeding Support Intervention Usual Care Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Coparenting Breastfeeding Support Intervention Usual Care Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/214 (0.00%)   0/214 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Coparenting Breastfeeding Support Intervention Usual Care Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/214 (0.00%)   0/214 (0.00%) 
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
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