- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07661550
Prevention of Postpartum Smoking Relapse and Related Health Consequences by Breastfeeding Promotion
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Xiaozhong Wen
- 전화번호: 716-829-6811
- 이메일: xiaozhon@buffalo.edu
연구 장소
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New York
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Buffalo, New York, 미국, 14214
- 모병
- 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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연락하다:
- Xiaozhong Wen
- 전화번호: 716-829-6811
- 이메일: xiaozhon@buffalo.edu
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: 주의 플라시보 대조군
일반 영유아 상담 및 지원
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The control group will receive instructions on general pregnancy and infant care from this project
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Number of participants reporting to smoke
기간: 12 months postpartum
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12 months postpartum
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Number of participants reporting to breastfeed
기간: 12months postpartum
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12months postpartum
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Systolic blood pressure level
기간: 12 months postpartum
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12 months postpartum
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Diastolic blood pressure level
기간: 12 months postpartum
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12 months postpartum
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Infant weight-for-length z-score
기간: 12 months of age
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12 months of age
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Infant length-for-age z-score
기간: 12 months of age
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12 months of age
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Infant head circumference
기간: 12 months of age
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12 months of age
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Infant arm circumference
기간: 12 months of age
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12 months of age
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Number of infants with bronchiolitis
기간: 12 months of age
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12 months of age
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공동 작업자 및 조사자
수사관
- 수석 연구원: Xiaozhong Wen, State University of New York at Buffalo
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .