Trial Outcomes & Findings for Prenatal Interventions to Promote Exclusive Breastfeeding (NCT NCT03107715)
NCT ID: NCT03107715
Last Updated: 2020-06-23
Results Overview
Single query "How do you plan to feed your baby?" with 4 possible responses Just formula / Both breastmilk and formula / Just breastmilk / Unsure
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
243 participants
Primary outcome timeframe
15 minutes
Results posted on
2020-06-23
Participant Flow
Participant milestones
| Measure |
Breastfeeding Champion
The Breastfeeding Champion Intervention (Intervention A) utilizes information about Breastfeeding Champions from the Coffective™ program: participants will be guided to tap and scroll through the content and will receive a follow up handout and encouragement to select a Champion.
Breastfeeding Champion: iPad-based behavioral intervention facilitated by researcher
|
Positive Messaging
The Positive Messaging Intervention (Intervention B) utilizes positive messaging from several sources and is modelled on the WIC Loving Support™ approach: participants will click on (istock-purchased) photographs which each reveal an informational statement about exclusive breastfeeding benefits and tips, followed by receipt of a summary handout.
Positive Messaging: iPad based behavioral intervention facilitated by researcher
|
|---|---|---|
|
Overall Study
STARTED
|
132
|
111
|
|
Overall Study
COMPLETED
|
128
|
104
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
Reasons for withdrawal
| Measure |
Breastfeeding Champion
The Breastfeeding Champion Intervention (Intervention A) utilizes information about Breastfeeding Champions from the Coffective™ program: participants will be guided to tap and scroll through the content and will receive a follow up handout and encouragement to select a Champion.
Breastfeeding Champion: iPad-based behavioral intervention facilitated by researcher
|
Positive Messaging
The Positive Messaging Intervention (Intervention B) utilizes positive messaging from several sources and is modelled on the WIC Loving Support™ approach: participants will click on (istock-purchased) photographs which each reveal an informational statement about exclusive breastfeeding benefits and tips, followed by receipt of a summary handout.
Positive Messaging: iPad based behavioral intervention facilitated by researcher
|
|---|---|---|
|
Overall Study
did not deliver at the home hospital
|
4
|
6
|
|
Overall Study
infant stillborn
|
0
|
1
|
Baseline Characteristics
Prenatal Interventions to Promote Exclusive Breastfeeding
Baseline characteristics by cohort
| Measure |
Breastfeeding Champion
n=132 Participants
The Breastfeeding Champion Intervention (Intervention A) utilizes information about Breastfeeding Champions from the Coffective™ program: participants will be guided to tap and scroll through the content and will receive a follow up handout and encouragement to select a Champion.
Breastfeeding Champion: iPad-based behavioral intervention facilitated by researcher
|
Positive Messaging
n=111 Participants
The Positive Messaging Intervention (Intervention B) utilizes positive messaging from several sources and is modelled on the WIC Loving Support™ approach: participants will click on (istock-purchased) photographs which each reveal an informational statement about exclusive breastfeeding benefits and tips, followed by receipt of a summary handout.
Positive Messaging: iPad based behavioral intervention facilitated by researcher
|
Total
n=243 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
129 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
239 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
|
24.4 years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
24.4 years
STANDARD_DEVIATION 4.4 • n=7 Participants
|
24.4 years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
132 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
127 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
226 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
132 participants
n=5 Participants
|
111 participants
n=7 Participants
|
243 participants
n=5 Participants
|
|
marital status
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 minutesSingle query "How do you plan to feed your baby?" with 4 possible responses Just formula / Both breastmilk and formula / Just breastmilk / Unsure
Outcome measures
| Measure |
Breastfeeding Champion
n=132 Participants
The Breastfeeding Champion Intervention (Intervention A) utilizes information about Breastfeeding Champions from the Coffective™ program: participants will be guided to tap and scroll through the content and will receive a follow up handout and encouragement to select a Champion.
Breastfeeding Champion: iPad-based behavioral intervention facilitated by researcher
|
Positive Messaging
n=111 Participants
The Positive Messaging Intervention (Intervention B) utilizes positive messaging from several sources and is modelled on the WIC Loving Support™ approach: participants will click on (istock-purchased) photographs which each reveal an informational statement about exclusive breastfeeding benefits and tips, followed by receipt of a summary handout.
Positive Messaging: iPad based behavioral intervention facilitated by researcher
|
|---|---|---|
|
Number of Participants Who Intended to Exclusively Breastfeed Post-intervention
Did not intend to exclusively breastfeed
|
86 Participants
|
67 Participants
|
|
Number of Participants Who Intended to Exclusively Breastfeed Post-intervention
Number who intended to exclusively breastfeed
|
40 Participants
|
36 Participants
|
|
Number of Participants Who Intended to Exclusively Breastfeed Post-intervention
Missing information
|
2 Participants
|
1 Participants
|
|
Number of Participants Who Intended to Exclusively Breastfeed Post-intervention
Did not deliver at home hospital
|
4 Participants
|
6 Participants
|
|
Number of Participants Who Intended to Exclusively Breastfeed Post-intervention
stillbirth
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 15 minutesSingle 5 point Likert scale with query "Was the intervention you received interesting and enjoyable?" Analyzed as all those who said 5 "very interesting" on a 5 point Likert scale; higher score indicates the participant liked/was more interested in the intervention; minimum score =1, maximum score = 5; No scale title - Question was: Was the intervention you received interesting and enjoyable? Please give us your overall impression on a scale from 1-5!
Outcome measures
| Measure |
Breastfeeding Champion
n=132 Participants
The Breastfeeding Champion Intervention (Intervention A) utilizes information about Breastfeeding Champions from the Coffective™ program: participants will be guided to tap and scroll through the content and will receive a follow up handout and encouragement to select a Champion.
Breastfeeding Champion: iPad-based behavioral intervention facilitated by researcher
|
Positive Messaging
n=111 Participants
The Positive Messaging Intervention (Intervention B) utilizes positive messaging from several sources and is modelled on the WIC Loving Support™ approach: participants will click on (istock-purchased) photographs which each reveal an informational statement about exclusive breastfeeding benefits and tips, followed by receipt of a summary handout.
Positive Messaging: iPad based behavioral intervention facilitated by researcher
|
|---|---|---|
|
Number of Participants Who Reported Their Intervention as "Very Interesting" (Response=5) on a 5 Point Likert Scale
|
89 participants
|
58 participants
|
SECONDARY outcome
Timeframe: 2 daysPopulation: Only able to include those who delivered at the home hospital
Was infant fed breastmilk only in-hospital postpartum (yes/no)
Outcome measures
| Measure |
Breastfeeding Champion
n=128 Participants
The Breastfeeding Champion Intervention (Intervention A) utilizes information about Breastfeeding Champions from the Coffective™ program: participants will be guided to tap and scroll through the content and will receive a follow up handout and encouragement to select a Champion.
Breastfeeding Champion: iPad-based behavioral intervention facilitated by researcher
|
Positive Messaging
n=104 Participants
The Positive Messaging Intervention (Intervention B) utilizes positive messaging from several sources and is modelled on the WIC Loving Support™ approach: participants will click on (istock-purchased) photographs which each reveal an informational statement about exclusive breastfeeding benefits and tips, followed by receipt of a summary handout.
Positive Messaging: iPad based behavioral intervention facilitated by researcher
|
|---|---|---|
|
Number of Participants Who Exclusively Breastfed In-hospital
|
79 Participants
|
66 Participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: those with feeding data at 2 weeks, 68 total missing for Champion and 46 total missing for Positive Messaging
Was infant fed breastmilk only at 2 weeks postpartum (yes/no)
Outcome measures
| Measure |
Breastfeeding Champion
n=64 Participants
The Breastfeeding Champion Intervention (Intervention A) utilizes information about Breastfeeding Champions from the Coffective™ program: participants will be guided to tap and scroll through the content and will receive a follow up handout and encouragement to select a Champion.
Breastfeeding Champion: iPad-based behavioral intervention facilitated by researcher
|
Positive Messaging
n=65 Participants
The Positive Messaging Intervention (Intervention B) utilizes positive messaging from several sources and is modelled on the WIC Loving Support™ approach: participants will click on (istock-purchased) photographs which each reveal an informational statement about exclusive breastfeeding benefits and tips, followed by receipt of a summary handout.
Positive Messaging: iPad based behavioral intervention facilitated by researcher
|
|---|---|---|
|
Number of Participants Who Exclusively Breastfed at 2 Weeks Postpartum
|
26 Participants
|
29 Participants
|
Adverse Events
Breastfeeding Champion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Positive Messaging
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Breastfeeding Champion
n=132 participants at risk
The Breastfeeding Champion Intervention (Intervention A) utilizes information about Breastfeeding Champions from the Coffective™ program: participants will be guided to tap and scroll through the content and will receive a follow up handout and encouragement to select a Champion.
Breastfeeding Champion: iPad-based behavioral intervention facilitated by researcher
|
Positive Messaging
n=111 participants at risk
The Positive Messaging Intervention (Intervention B) utilizes positive messaging from several sources and is modelled on the WIC Loving Support™ approach: participants will click on (istock-purchased) photographs which each reveal an informational statement about exclusive breastfeeding benefits and tips, followed by receipt of a summary handout.
Positive Messaging: iPad based behavioral intervention facilitated by researcher
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
still birth
|
0.00%
0/132 • 24 months
no study related adverse events;
|
0.90%
1/111 • 24 months
no study related adverse events;
|
Other adverse events
Adverse event data not reported
Additional Information
Lydia Furman MD, PI
University Hospitals Rainbow Babies and Children's Hospital
Phone: 216-844=8260
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place