Trial Outcomes & Findings for Evaluating a Coparenting Breastfeeding Support Intervention (NCT NCT01536119)
NCT ID: NCT01536119
Last Updated: 2014-01-24
Results Overview
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).
COMPLETED
NA
428 participants
12 weeks postpartum
2014-01-24
Participant Flow
Recruitment took place at on the postpartum unit of a large Toronto hospital between March 26th and July 15th 2012
Eligibility determined before recruitment into trial.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
214
|
214
|
|
Overall Study
COMPLETED
|
197
|
200
|
|
Overall Study
NOT COMPLETED
|
17
|
14
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
17
|
14
|
Baseline Characteristics
Evaluating a Coparenting Breastfeeding Support Intervention
Baseline characteristics by cohort
| Measure |
Coparenting Breastfeeding Support Intervention
n=214 Participants
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
n=214 Participants
The usual care group will receive standard postpartum care in the hospital and in the community
|
Total
n=428 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
107 participants
n=5 Participants
|
107 participants
n=7 Participants
|
214 participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Continuous
|
30.4 years
STANDARD_DEVIATION 3.7 • n=5 Participants
|
30.7 years
STANDARD_DEVIATION 3.8 • n=7 Participants
|
30.6 years
STANDARD_DEVIATION 3.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
107 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
107 participants
n=5 Participants
|
107 participants
n=7 Participants
|
214 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks postpartumPopulation: Analysis population included only mothers
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).
Outcome measures
| Measure |
Coparenting Breastfeeding Support Intervention
n=104 Participants
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
n=105 Participants
The usual care group will receive standard postpartum care in the hospital and in the community
|
|---|---|---|
|
Exclusive Breastfeeding Rate at 12 Weeks Postpartum
|
70 percentage of participants
|
63 percentage of participants
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Analysis population included only mothers
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).
Outcome measures
| Measure |
Coparenting Breastfeeding Support Intervention
n=104 Participants
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
n=102 Participants
The usual care group will receive standard postpartum care in the hospital and in the community
|
|---|---|---|
|
Exclusive Breastfeeding
|
75 percentage of participants
|
62 percentage of participants
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Analysis population included only mothers
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.
Outcome measures
| Measure |
Coparenting Breastfeeding Support Intervention
n=104 Participants
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
n=102 Participants
The usual care group will receive standard postpartum care in the hospital and in the community
|
|---|---|---|
|
Any Breastfeeding
|
102 participants
|
94 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Analysis population included only mothers
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.
Outcome measures
| Measure |
Coparenting Breastfeeding Support Intervention
n=104 Participants
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
n=105 Participants
The usual care group will receive standard postpartum care in the hospital and in the community
|
|---|---|---|
|
Any Breastfeeding
|
100 participants
|
92 participants
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Analysis population included only mothers who completed the questionnaire at 6 weeks postpartum.
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.
Outcome measures
| Measure |
Coparenting Breastfeeding Support Intervention
n=98 Participants
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
n=91 Participants
The usual care group will receive standard postpartum care in the hospital and in the community
|
|---|---|---|
|
Coparenting Relationship
|
73.01 units on a scale
Standard Deviation 9.8
|
71.3 units on a scale
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: 12 weeks postpartumPopulation: Analysis population included only mothers who completed the scale at 12 weeks postpartum.
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.
Outcome measures
| Measure |
Coparenting Breastfeeding Support Intervention
n=100 Participants
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
n=96 Participants
The usual care group will receive standard postpartum care in the hospital and in the community
|
|---|---|---|
|
Coparenting Relationship
|
179.9 units on a scale
Standard Deviation 27.4
|
174.9 units on a scale
Standard Deviation 27.4
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Analysis population included only mothers who completed the scale at 6 weeks postpartum.
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.
Outcome measures
| Measure |
Coparenting Breastfeeding Support Intervention
n=98 Participants
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
n=91 Participants
The usual care group will receive standard postpartum care in the hospital and in the community
|
|---|---|---|
|
Breastfeeding Support
|
88.0 units on a scale
Standard Deviation 10.9
|
85.6 units on a scale
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Analysis population included only mothers who completed the scale at 12 weeks postpartum
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.
Outcome measures
| Measure |
Coparenting Breastfeeding Support Intervention
n=100 Participants
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
n=96 Participants
The usual care group will receive standard postpartum care in the hospital and in the community
|
|---|---|---|
|
Breastfeeding Support
|
86.6 units on a scale
Standard Deviation 11.7
|
83.6 units on a scale
Standard Deviation 14.4
|
SECONDARY outcome
Timeframe: 6 weeks postpartumPopulation: 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).
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.
Outcome measures
| Measure |
Coparenting Breastfeeding Support Intervention
n=93 Participants
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
n=95 Participants
The usual care group will receive standard postpartum care in the hospital and in the community
|
|---|---|---|
|
Paternal Breastfeeding Self-Efficacy
|
55.9 units on a scale
Standard Deviation 8.4
|
53.1 units on a scale
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: 6 weeks postpartumPopulation: Analysis population included only fathers who completed the scale at 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.
Outcome measures
| Measure |
Coparenting Breastfeeding Support Intervention
n=93 Participants
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
n=95 Participants
The usual care group will receive standard postpartum care in the hospital and in the community
|
|---|---|---|
|
Paternal Infant Feeding Attitude
|
62.1 units on a scale
Standard Deviation 8.1
|
61.2 units on a scale
Standard Deviation 6.7
|
Adverse Events
Coparenting Breastfeeding Support Intervention
Usual Care Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place