Breastfeeding, Smoking, Cigarette
Conditions
Keywords
Pregnancy, Postpartum, Smoking abstinence, Breastfeeding intention, Breastfeeding duration
Brief summary
This pilot clinical trial aims to integrate maternal smoking cessation and breastfeeding interventions to enhance both cancer prevention behaviors. The investigators will recruit 40 daily smoking women in their early pregnancy and randomize them into the integrated intervention or control group. Main outcomes include smoking abstinence and breastfeeding rates at 6 months postpartum.
Detailed description
The investigators are proposing the first randomized controlled trial to integrate maternal smoking cessation and breastfeeding interventions to enhance both cancer prevention behaviors. The investigators will recruit 40 daily smoking women in their 1st or 2nd trimester of pregnancy (≤28 weeks) from local obstetric clinics, communities, and social media. They will be randomized into either the intervention (N=20) or control group (N=20). The two groups will complete the same number of sessions (6 during pregnancy and 3 postpartum), but focus on different topics. Specifically, the control group will receive instructions on general pregnancy and infant care. The intervention group will receive instructions on general pregnancy and infant care, plus an integrated multicomponent intervention that promotes both smoking cessation and breastfeeding (i.e., education and counseling, monitoring and feedback, and contingent financial incentives). Two female Certified Lactation Counselors (interventionists) will be trained to run study sessions during home visits. Interventionists will provide additional support via phone and text messaging until 6 months postpartum. Main outcomes include smoking abstinence and breastfeeding rates at 6 months postpartum within the duration of this award.
Interventions
BEHAVIORALIntegrated 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.
BEHAVIORALAttention 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).
Sponsors
National Center for Advancing Translational Sciences (NCATS)
Xiaozhong Wen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Research staff who collect and analyze outcome data will be blinded to participants' group assignments.
Intervention model description
The 40 eligible participants will be randomized into either the intervention (N=20) or control group (N=20). A sequence of random numbers in blocks of 2 will be used to ensure equal numbers of participants for each group over time.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Be 18 years or older * At ≤28 weeks of pregnancy * Daily smoking cigarettes and/or cigars in the past 7 days * Be able to read, listen, and talk in English
Exclusion criteria
* Being diagnosed with cancer * Current heavy drinking (more than 2 drinks a day) * Current use of illicit substances * Medical conditions contraindicating breastfeeding such as HIV infection, active tuberculosis, and breast removal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Smoking Abstinence | 6 months postpartum | 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). |
| Number of Participants With Reported Intent to Breastfeed | 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). |
| Number of Participants Reporting to Breastfeed | 6 months postpartum | During 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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). | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Attention Placebo Control Group | Integrated Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 19 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Pregnancy status Not pregnant | 0 Participants | 0 Participants | 0 Participants |
| Pregnancy status Pregnant | 20 Participants | 20 Participants | 40 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 18 Participants | 37 Participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Number of Participants Reporting to Breastfeed
During 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.
Time frame: 6 months postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Integrated Intervention | Number of Participants Reporting to Breastfeed | 6 Participants |
| Attention Placebo Control Group | Number of Participants Reporting to Breastfeed | 3 Participants |
Primary
Number of Participants With Reported Intent to Breastfeed
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).
Time frame: 35 weeks of pregnancy (the end of pregnancy)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Integrated Intervention | Number of Participants With Reported Intent to Breastfeed | 16 Participants |
| Attention Placebo Control Group | Number of Participants With Reported Intent to Breastfeed | 10 Participants |
Primary
Number of Participants With Smoking Abstinence
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).
Time frame: 6 months postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Integrated Intervention | Number of Participants With Smoking Abstinence | 8 Participants |
| Attention Placebo Control Group | Number of Participants With Smoking Abstinence | 3 Participants |