Clinical trial NCT04670822: Postpartum Smoking Relapse Prevention by Breastfeeding Promotion
Official title: Postpartum Smoking Relapse Prevention by Breastfeeding Promotion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking, Cigarette
Breastfeeding
Keywords: Postpartum
Relapse
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-12-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized controlled trial to prevent postpartum smoking relapse by breastfeeding promotion. The intervention group (N=30) will receive multicomponent breastfeeding intervention from late pregnancy to 6 months postpartum, while the attention placebo control group (N=30) will receive general infant care counseling and support. The key outcome is the rate of postpartum smoking relapse.

Detailed description: The investigators propose the first randomized controlled trial to reduce postpartum smoking relapse by breastfeeding promotion from late pregnancy to 6 months postpartum. The investigators will enroll 60 pregnant women who successfully quit smoking within 3 months before or during this pregnancy (\<28 weeks). All participants will receive breastfeeding education during late pregnancy. Right after delivery, participants who are still smoking abstinent will be randomized into either the breastfeeding intervention group (N=30) or the attention placebo control group (N=30). The intervention group will receive multicomponent interventions consisting of postnatal lactation counseling, family/peer/employer support, contingent financial incentives, and early limited formula milk via syringe (optional for at-risk infants). The control group will receive counseling and support focusing on general infant care with attention and compensation similar to the intervention group. The primary outcomes are rates of postpartum smoking relapse verified by urine cotinine test.

Specific Aim 1 is to examine the efficacy of breastfeeding promotion intervention on postpartum smoking relapse. Specific Aim 2 is to collect preliminary data regarding potential mediating mechanisms: increases in lactation hormones (plasma oxytocin and prolactin), reductions in stress and negative affect, and enhancing mother-infant bonding and maternal motivation to protect the infant from secondhand smoke exposure. This innovative and feasible pilot study can yield promising preliminary data to strongly support our future application of a NIH R01 grant proposal that has the potential to reduce smoking-related harms to both the mother and the infant, and maximize the protective effects of breastfeeding on infant health and development.

Eligibility criteria: Inclusion Criteria:

* Be pregnant or in the first 1 month postpartum
* Be 18 years or older
* Have quit smoking cigarettes during or before 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 (more than 2 drinks a day)
* Current use of illicit substances
* Being strongly against breastfeeding

Primary outcomes:
measure: Number of Participants Reporting to Breastfeed
timeFrame: 9 months postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Division of Behavioral Medicine Department of Pediatrics Jacobs School of Medicine and Biomedical Sciences State University of New York at Buffalo
state: New York
Study officials:
affiliation: State University of New York at Buffalo
name: Xiaozhong Wen
role: PRINCIPAL_INVESTIGATOR
References: