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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD117113 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breastfeeding intervention grou | Experimental | A multicomponent behavioral intervention to promote breastfeeding |
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| Attention placebo control group | Placebo Comparator | General infant care counseling and support |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breastfeeding promotion | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants reporting to smoke | 12 months postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants reporting to breastfeed | 12months postpartum | |
| Systolic blood pressure level | 12 months postpartum | |
| Diastolic blood pressure level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaozhong Wen | Contact | 716-829-6811 | xiaozhon@buffalo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Xiaozhong Wen | State University of New York at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Behavioral Medicine Department of Pediatrics Jacobs School of Medicine and Biomedical Sciences State University of New York at Buffalo | Recruiting | Buffalo | New York | 14214 | United States |
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| D001942 | Breast Feeding |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D005247 |
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| Attention placebo control | Behavioral | The control group will receive instructions on general pregnancy and infant care from this project |
|
| 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 |
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| Feeding Behavior |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |