- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07661550
Prevention of Postpartum Smoking Relapse and Related Health Consequences by Breastfeeding Promotion
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Xiaozhong Wen
- Telefonnummer: 716-829-6811
- E-mail: xiaozhon@buffalo.edu
Studiesteder
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New York
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Buffalo, New York, Forenede Stater, 14214
- Rekruttering
- Division of Behavioral Medicine Department of Pediatrics Jacobs School of Medicine and Biomedical Sciences State University of New York at Buffalo
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Kontakt:
- Xiaozhong Wen
- Telefonnummer: 716-829-6811
- E-mail: xiaozhon@buffalo.edu
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Placebo komparator: Opmærksomhed placebo kontrolgruppe
Generel rådgivning og støtte til spædbørnspleje
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The control group will receive instructions on general pregnancy and infant care from this project
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Eksperimentel: Breastfeeding intervention grou
A multicomponent behavioral intervention to promote breastfeeding
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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).
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number of participants reporting to smoke
Tidsramme: 12 months postpartum
|
12 months postpartum
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number of participants reporting to breastfeed
Tidsramme: 12months postpartum
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12months postpartum
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Systolic blood pressure level
Tidsramme: 12 months postpartum
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12 months postpartum
|
|
Diastolic blood pressure level
Tidsramme: 12 months postpartum
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12 months postpartum
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Infant weight-for-length z-score
Tidsramme: 12 months of age
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12 months of age
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Infant length-for-age z-score
Tidsramme: 12 months of age
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12 months of age
|
|
Infant head circumference
Tidsramme: 12 months of age
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12 months of age
|
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Infant arm circumference
Tidsramme: 12 months of age
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12 months of age
|
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Number of infants with bronchiolitis
Tidsramme: 12 months of age
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12 months of age
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Xiaozhong Wen, State University of New York at Buffalo
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STUDY00002632
- R01HD117113 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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