Postpartum Smoking Relapse Prevention by Breastfeeding Promotion

Study Overview
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Brief Summary
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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
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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.

Official Title
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Postpartum Smoking Relapse Prevention by Breastfeeding Promotion

Conditions
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Smoking, Cigarette, Breastfeeding

Intervention / Treatment
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* Behavioral: Breastfeeding promotion
* Behavioral: Attention placebo control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breastfeeding intervention group<br>A multicomponent behavioral intervention to promote breastfeeding | Behavioral: Breastfeeding promotion<br>* The intervention group will receive multicomponent interventions consisting of 7 half-hour postnatal visits for lactation counseling, family/peer/employer support, contingent financial incentives, and early limited formula milk via syringe (optional for at-risk infants).<br>|
| Placebo Comparator: Attention placebo control group<br>General infant care counseling and support | Behavioral: Attention placebo control<br>* The attention placebo control group will complete the same frequency and duration of study visits as the intervention group but focus on general infant care counseling and support.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of smoking relapse | The date of postpartum relapse will be defined as the first day after delivery on which an ex-smoker has smoked for 7 consecutive days. Reported smoking abstinence will be verified by urine cotinine test. | 6 months postpartum (post-test) | 
| Rates of smoking relapse | The date of postpartum relapse will be defined as the first day after delivery on which an ex-smoker has smoked for 7 consecutive days. Reported smoking abstinence will be verified by urine cotinine test. | 9 months postpartum (follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breastfeeding duration | Postpartum mothers will report their current feeding method, frequency, and duration of breastfeeding and/or formula use. Breastfeeding status will be visually verified by a female research staff, looking for one of the following indicators of successful breastfeeding in the infant - audible swallowing, a regular suck/swallow/breath pattern, or visible milk in the infant's mouth after they are not latched anymore. | Up to 9 months postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum, Relapse