Trial Outcomes & Findings for The Impact of Telelactation Services on Breastfeeding Outcomes (NCT NCT04856163)
NCT ID: NCT04856163
Last Updated: 2025-01-03
Results Overview
Number of participants who report any breastfeeding at 6 months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2108 participants
Primary outcome timeframe
6 months postpartum
Results posted on
2025-01-03
Participant Flow
Participant milestones
| Measure |
Telelactation Support
Participants in the experimental group received unlimited, free telelactation visits with lactation consultants (IBCLCs) as demanded up to 24 weeks post-partum. Services were available through mobile phone app.
|
Ebook
Participants in the control arm received care as usual. They will received a ebook with content on infant care.
|
|---|---|---|
|
Overall Study
STARTED
|
1052
|
1056
|
|
Overall Study
COMPLETED
|
955
|
956
|
|
Overall Study
NOT COMPLETED
|
97
|
100
|
Reasons for withdrawal
| Measure |
Telelactation Support
Participants in the experimental group received unlimited, free telelactation visits with lactation consultants (IBCLCs) as demanded up to 24 weeks post-partum. Services were available through mobile phone app.
|
Ebook
Participants in the control arm received care as usual. They will received a ebook with content on infant care.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
97
|
100
|
Baseline Characteristics
The Impact of Telelactation Services on Breastfeeding Outcomes
Baseline characteristics by cohort
| Measure |
Telelactation Support
n=1052 Participants
Participants in the experimental group received unlimited, free telelactation visits with lactation consultants (IBCLCs) as demanded up to 24 weeks post-partum. Services were available through mobile phone app.
|
Ebook
n=1056 Participants
Participants in the control arm received care as usual. They also received an ebook with content on infant care.
|
Total
n=2108 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
|
1052 Participants
n=5 Participants
|
1056 Participants
n=7 Participants
|
2108 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1052 Participants
n=5 Participants
|
1056 Participants
n=7 Participants
|
2108 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
383 Participants
n=5 Participants
|
380 Participants
n=7 Participants
|
763 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
669 Participants
n=5 Participants
|
676 Participants
n=7 Participants
|
1345 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
35 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
49 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
301 Participants
n=5 Participants
|
310 Participants
n=7 Participants
|
611 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
509 Participants
n=5 Participants
|
474 Participants
n=7 Participants
|
983 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
149 Participants
n=5 Participants
|
195 Participants
n=7 Participants
|
344 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Health insurance
Medicaid or Uninsured
|
323 Participants
n=5 Participants
|
312 Participants
n=7 Participants
|
635 Participants
n=5 Participants
|
|
Health insurance
Commercial or Other
|
729 Participants
n=5 Participants
|
744 Participants
n=7 Participants
|
1473 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months postpartumNumber of participants who report any breastfeeding at 6 months
Outcome measures
| Measure |
Telelactation Support
n=955 Participants
Participants in the experimental group received unlimited, free telelactation visits with lactation consultants (IBCLCs) as demanded up to 24 weeks post-partum. Services were be available through mobile phone app.
|
Ebook
n=956 Participants
Participants in the control arm received care as usual. They also received a ebook with content on infant care.
|
|---|---|---|
|
Breastfeeding Duration 1
|
674 Participants
|
639 Participants
|
PRIMARY outcome
Timeframe: 6 months post-partumTime to cessation of breastfeeding in months (as measured by reported age of infant when completely stopped receiving breastmilk)
Outcome measures
| Measure |
Telelactation Support
n=955 Participants
Participants in the experimental group received unlimited, free telelactation visits with lactation consultants (IBCLCs) as demanded up to 24 weeks post-partum. Services were be available through mobile phone app.
|
Ebook
n=956 Participants
Participants in the control arm received care as usual. They also received a ebook with content on infant care.
|
|---|---|---|
|
Breastfeeding Duration 2
|
4.4 months
Standard Deviation 2
|
4.5 months
Standard Deviation 2
|
PRIMARY outcome
Timeframe: 6 months postpartumNumber of participants who report no formula use at 6 months
Outcome measures
| Measure |
Telelactation Support
n=955 Participants
Participants in the experimental group received unlimited, free telelactation visits with lactation consultants (IBCLCs) as demanded up to 24 weeks post-partum. Services were be available through mobile phone app.
|
Ebook
n=956 Participants
Participants in the control arm received care as usual. They also received a ebook with content on infant care.
|
|---|---|---|
|
Breastfeeding Exclusivity
|
448 Participants
|
422 Participants
|
SECONDARY outcome
Timeframe: 6 months postpartumBreastfeeding satisfaction at 6 months postpartum. Score on five-item maternal/infant breastfeeding satisfaction scale (which is a subscale of the Hill and Humenick lactation scale). Higher values indicate more agreement with the measures of satisfaction, resulting in a composite satisfaction score ranging from 5 to 25 for the subscale.
Outcome measures
| Measure |
Telelactation Support
n=952 Participants
Participants in the experimental group received unlimited, free telelactation visits with lactation consultants (IBCLCs) as demanded up to 24 weeks post-partum. Services were be available through mobile phone app.
|
Ebook
n=956 Participants
Participants in the control arm received care as usual. They also received a ebook with content on infant care.
|
|---|---|---|
|
Breastfeeding Satisfaction
|
19.49 score on a scale
Standard Deviation 5.43
|
18.95 score on a scale
Standard Deviation 5.60
|
Adverse Events
Telelactation Support
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ebook
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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