Effect of a Self-Efficacy-Based Educational Intervention on Breastfeending in Primigravid Women: A Randomized Controlled Trial (PROMILACT)
Effect of a Self-Efficacy-Based Educational Intervention on Exclusive Breastfeeding in Primigravid Women Attending a Primary Care Center: A Randomized Controlled Trial
연구 개요
상태
상세 설명
Exclusive breastfeeding is recognized as one of the most effective interventions for improving maternal and infant health outcomes. However, breastfeeding rates remain below international recommendations in many settings, particularly among first-time mothers who may experience uncertainty, lack of confidence, and insufficient support during the prenatal and postpartum periods.
Self-efficacy theory suggests that maternal confidence plays a critical role in breastfeeding initiation and maintenance. Educational interventions based on self-efficacy principles may improve breastfeeding behaviors and increase exclusive breastfeeding duration.
This study is a randomized controlled trial conducted in a primary care setting of the Mexican Social Security Institute (IMSS) in Acapulco, Guerrero, Mexico. The study will include primigravid women in the third trimester of pregnancy receiving prenatal care at Unidad de Medicina Familiar No. 9.
Participants assigned to the intervention group will receive a structured educational intervention consisting of four weekly sessions lasting approximately 90 minutes each. The sessions will address breastfeeding physiology, breastfeeding techniques, common breastfeeding difficulties, emotional support, and strategies to improve maternal self-efficacy. The control group will continue receiving standard prenatal care routinely provided by the institution.
The primary outcomes will include breastfeeding self-efficacy and exclusive breastfeeding rates during postpartum follow-up. Secondary outcomes may include breastfeeding knowledge and breastfeeding continuation at different postpartum time points.
Breastfeeding self-efficacy will be evaluated using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF). Follow-up evaluations will be performed at 1 and 3 months postpartum.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Guadalupe Aguilar Hernández, MD
- 전화번호: +527442298212
- 이메일: guadalupe.aguilarhe@imss.gob.mx
연구 장소
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Guerrero
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Acapulco de Juárez, Guerrero, 멕시코, 39300
- Unidad de Medicina Familiar No. 9
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연락하다:
- Guadalupe Aguilar Hernández, MD
- 전화번호: +52 7442298212
- 이메일: guadalupe.aguilarhe@imss.gob.mx
-
수석 연구원:
- Guadalupe Aguilar Hernández, MD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Pregnant women aged 18 years or older
- Primigravidae in the third trimester of pregnancy
- Receiving prenatal care at UMF No. 9, IMSS
- Ability to attend the educational sessions
- Willingness to participate and sign informed consent
Exclusion Criteria:
- High-risk pregnancy
- Medical conditions contraindicating breastfeeding
- Cognitive impairment or communication difficulties preventing participation
- Previous participation in breastfeeding educational programs
- Failure to complete follow-up evaluations
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Educational Intervention Group
Participants will receive a breastfeeding educational intervention based on self-efficacy theory during the third trimester of pregnancy.
The intervention includes four weekly sessions focused on breastfeeding knowledge, techniques, confidence building, and problem-solving strategies.
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Participants will receive four weekly educational sessions during the third trimester of pregnancy based on breastfeeding self-efficacy theory.
Sessions will include breastfeeding education, practical techniques, confidence building, problem-solving strategies, and support to improve exclusive breastfeeding practices postpartum.
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간섭 없음: Control Group
Participants will receive standard prenatal care routinely provided at the family medicine unit without the additional breastfeeding educational intervention.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Exclusive Breastfeeding Rate at 3 Months Postpartum
기간: 3 months postpartum
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Proportion of mothers who maintain exclusive breastfeeding at 3 months postpartum after receiving an educational intervention based on breastfeeding self-efficacy.
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3 months postpartum
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공동 작업자 및 조사자
수사관
- 수석 연구원: Guadalupe Aguilar Hernández, MD, INSTITUTO MEXICANO DEL SEGURO SOCIAL, UNIDAD DE MEDICINA FAMILIAR NO. 9
- 연구 책임자: Sergio Paredes Solis, MD, Centro de Investigación de Enfermedades Tropicales, Universidad Autonoma de Guerrero
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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 연구와 관련된 용어
기타 연구 ID 번호
- IMSS-UMF-BSES-2026
- R-2026-1101-006 (레지스트리 식별자: SIRELCIS)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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