Trial Outcomes & Findings for Postpartum Smoking Relapse Prevention by Breastfeeding Promotion (NCT NCT04670822)
NCT ID: NCT04670822
Last Updated: 2025-05-15
Results Overview
During postpartum, mothers report their breastfeeding status (exclusive, mixed with formula, non-breastfeeding) every month until 9 months postpartum. Any breastfeeding is defined as exclusive breastfeeding or mixed-feeding breast milk and formula.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
9 months postpartum
Results posted on
2025-05-15
Participant Flow
Participant milestones
| Measure |
Breastfeeding Intervention Group
A multicomponent behavioral intervention to promote breastfeeding
|
Attention Placebo Control Group
General infant care counseling and support
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
25
|
24
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Postpartum Smoking Relapse Prevention by Breastfeeding Promotion
Baseline characteristics by cohort
| Measure |
Breastfeeding Intervention Group
n=30 Participants
A multicomponent behavioral intervention to promote breastfeeding
|
Attention Placebo Control Group
n=30 Participants
General infant care counseling and support
|
Total
n=60 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
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 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
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Pregnancy status
Pregnant
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Pregnancy status
Not pregnant
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 months postpartumDuring postpartum, mothers report their breastfeeding status (exclusive, mixed with formula, non-breastfeeding) every month until 9 months postpartum. Any breastfeeding is defined as exclusive breastfeeding or mixed-feeding breast milk and formula.
Outcome measures
| Measure |
Breastfeeding Intervention Group
n=25 Participants
A multicomponent behavioral intervention to promote breastfeeding
|
Attention Placebo Control Group
n=24 Participants
General infant care counseling and support
|
|---|---|---|
|
Number of Participants Reporting to Breastfeed
|
13 Participants
|
5 Participants
|
Adverse Events
Breastfeeding Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Attention Placebo Control Group
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
Dr. Xiaozhong Wen
State University of New York at Buffalo
Phone: 7168296811
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place