Trial Outcomes & Findings for Lung and Breast Cancer Prevention by an Integrated Intervention of Maternal Smoking Cessation and Breastfeeding (NCT NCT05123118)
NCT ID: NCT05123118
Last Updated: 2025-04-17
Results Overview
Based on their recorded daily numbers of cigarettes and cigars smoked after enrollment, the investigators will classify smoking abstinence status in the past 7 days (7-day point-prevalence). The self-reported smoking abstinence will be biochemically confirmed by urine cotinine tests (\<50 ng/mL).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
6 months postpartum
Results posted on
2025-04-17
Participant Flow
Participant milestones
| Measure |
Integrated Intervention
Integrated intervention of smoking cessation and breastfeeding
Integrated intervention of smoking cessation and breastfeeding: The intervention group will receive an integrated intervention of smoking cessation and breastfeeding: education and counseling, monitoring and feedback, and contingent financial incentives.
|
Attention Placebo Control Group
Instructions on general pregnancy and infant care
Attention placebo control: Participants in the control group will receive usual prenatal care from physicians, nurses, or social workers. They will receive best standard care on smoking cessation and breastfeeding, including referral to the New York State Smokers' Quitline and the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lung and Breast Cancer Prevention by an Integrated Intervention of Maternal Smoking Cessation and Breastfeeding
Baseline characteristics by cohort
| Measure |
Integrated Intervention
n=20 Participants
Integrated intervention of smoking cessation and breastfeeding
Integrated intervention of smoking cessation and breastfeeding: The intervention group will receive an integrated intervention of smoking cessation and breastfeeding: education and counseling, monitoring and feedback, and contingent financial incentives.
|
Attention Placebo Control Group
n=20 Participants
Instructions on general pregnancy and infant care
Attention placebo control: Participants in the control group will receive usual prenatal care from physicians, nurses, or social workers. They will receive best standard care on smoking cessation and breastfeeding, including referral to the New York State Smokers' Quitline and the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).
|
Total
n=40 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
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 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
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 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
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 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: 6 months postpartumBased on their recorded daily numbers of cigarettes and cigars smoked after enrollment, the investigators will classify smoking abstinence status in the past 7 days (7-day point-prevalence). The self-reported smoking abstinence will be biochemically confirmed by urine cotinine tests (\<50 ng/mL).
Outcome measures
| Measure |
Integrated Intervention
n=20 Participants
Integrated intervention of smoking cessation and breastfeeding
Integrated intervention of smoking cessation and breastfeeding: The intervention group will receive an integrated intervention of smoking cessation and breastfeeding: education and counseling, monitoring and feedback, and contingent financial incentives.
|
Attention Placebo Control Group
n=20 Participants
Instructions on general pregnancy and infant care
Attention placebo control: Participants in the control group will receive usual prenatal care from physicians, nurses, or social workers. They will receive best standard care on smoking cessation and breastfeeding, including referral to the New York State Smokers' Quitline and the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).
|
|---|---|---|
|
Number of Participants With Smoking Abstinence
|
8 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 35 weeks of pregnancy (the end of pregnancy)During pregnancy, participants will report breastfeeding intention using questionnaires modified from the Infant Feeding Practices Study II. The question is, "What method do you plan to use to feed your new baby in the first few weeks?" with 4 response options: 1) breastfeeding only (baby will not be given formula), 2) formula feed only, 3) both breastfeed and formula feed, or 4) unsure. We create a binary variable to indicate breastfeeding intentions (option 1 or 3) or other feeding intentions (option 2 or 4).
Outcome measures
| Measure |
Integrated Intervention
n=20 Participants
Integrated intervention of smoking cessation and breastfeeding
Integrated intervention of smoking cessation and breastfeeding: The intervention group will receive an integrated intervention of smoking cessation and breastfeeding: education and counseling, monitoring and feedback, and contingent financial incentives.
|
Attention Placebo Control Group
n=20 Participants
Instructions on general pregnancy and infant care
Attention placebo control: Participants in the control group will receive usual prenatal care from physicians, nurses, or social workers. They will receive best standard care on smoking cessation and breastfeeding, including referral to the New York State Smokers' Quitline and the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).
|
|---|---|---|
|
Number of Participants With Reported Intent to Breastfeed
|
16 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 6 months postpartumDuring postpartum, mothers report their breastfeeding status (exclusive, mixed with formula, non-breastfeeding) every month until 6 months postpartum. Any breastfeeding is defined as exclusive breastfeeding or mixed-feeding breast milk and formula.
Outcome measures
| Measure |
Integrated Intervention
n=16 Participants
Integrated intervention of smoking cessation and breastfeeding
Integrated intervention of smoking cessation and breastfeeding: The intervention group will receive an integrated intervention of smoking cessation and breastfeeding: education and counseling, monitoring and feedback, and contingent financial incentives.
|
Attention Placebo Control Group
n=15 Participants
Instructions on general pregnancy and infant care
Attention placebo control: Participants in the control group will receive usual prenatal care from physicians, nurses, or social workers. They will receive best standard care on smoking cessation and breastfeeding, including referral to the New York State Smokers' Quitline and the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).
|
|---|---|---|
|
Number of Participants Reporting to Breastfeed
|
6 Participants
|
3 Participants
|
Adverse Events
Integrated Intervention
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