Breastfeeding, Smoking ( Cigarette)
Conditions
Keywords
Pregnancy, Postpartum, Relapse
Brief summary
The objective of this randomized controlled trial is to examine the efficacy of a new intervention to prevent postpartum smoking relapse and related health consequences through breastfeeding promotion. After the pre-test, ex-smokers who are still abstinent from smoking will be randomized into either the breastfeeding intervention or the attention placebo control group. The outcomes are postpartum smoking relapse, breastfeeding practices, and maternal and child health.
Detailed description
We propose a randomized controlled trial to reduce postpartum smoking relapse by breastfeeding promotion from late pregnancy to 12 months postpartum. We will enroll 280 pregnant mothers who successfully quit smoking during this pregnancy (≤28 weeks). After the pre-test, participants who are still smoking abstinent will be randomized into either the breastfeeding intervention group (N=140) or the attention control group (N=140). The intervention group will receive a multicomponent intervention consisting of breastfeeding education, lactation counseling, social support, contingent financial incentives, and early limited formula milk via syringe feeding (optional for at-risk infants). The control group will receive counseling and support focusing on general infant care, with attention and monetary earnings similar to the intervention group. Both groups will receive usual care (i.e., information, education, and Quitline) for postpartum smoking relapse. The outcomes are postpartum smoking relapse, breastfeeding practices, and maternal and child health. Aim 1 is to examine the efficacy of breastfeeding promotion intervention on postpartum smoking relapse. Aim 2 is to examine potential mediating mechanisms: reductions in stress and negative affect, enhancing mother-infant bonding and maternal sensitivity, and maternal weight retention. Aim 3 is to assess the effects of breastfeeding promotion intervention on maternal and infant health among ex-smoking mothers. This innovative study can yield promising data to support a new intervention to prevent postpartum smoking relapse. It has the potential to reduce smoking-related harms to both the mother and the infant, maximize the protective effects of breastfeeding on infant health and development, and narrow health disparities.
Interventions
BEHAVIORALBreastfeeding promotion
The intervention group will receive a multicomponent intervention promoting breastfeeding, including education, lactation counseling, social support, breastfeeding-contingent financial incentives, and early limited formula milk via syringe feeding (optional for at-risk infants).
BEHAVIORALAttention placebo control
The control group will receive instructions on general pregnancy and infant care from this project
Sponsors
State University of New York at Buffalo
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Be pregnant * Be 18 years or older * Have quit smoking cigarettes during this pregnancy * Be willing to receive infant care and breastfeeding education * Be able to read, listen, and talk in English
Exclusion criteria
* Medical conditions contraindicating breastfeeding, such as HIV infection, active tuberculosis, and breast removal * Current heavy drinking (≥4 standard drinks on any day or ≥8 standard drinks per week)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants reporting to smoke | 12 months postpartum |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants reporting to breastfeed | 12months postpartum |
| Systolic blood pressure level | 12 months postpartum |
| Diastolic blood pressure level | 12 months postpartum |
| Infant weight-for-length z-score | 12 months of age |
| Infant length-for-age z-score | 12 months of age |
| Infant head circumference | 12 months of age |
| Infant arm circumference | 12 months of age |
| Number of infants with bronchiolitis | 12 months of age |
Countries
United States
Contacts
CONTACTXiaozhong Wen
PRINCIPAL_INVESTIGATORXiaozhong Wen
State University of New York at Buffalo
Outcome results
None listed