- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07593716
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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Guadalupe Aguilar Hernández, MD
- Telefonnummer: +527442298212
- E-post: guadalupe.aguilarhe@imss.gob.mx
Studiesteder
-
-
Guerrero
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Acapulco de Juárez, Guerrero, Mexico, 39300
- Unidad de Medicina Familiar No. 9
-
Ta kontakt med:
- Guadalupe Aguilar Hernández, MD
- Telefonnummer: +52 7442298212
- E-post: guadalupe.aguilarhe@imss.gob.mx
-
Hovedetterforsker:
- Guadalupe Aguilar Hernández, MD
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
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.
|
|
Ingen inngripen: Control Group
Participants will receive standard prenatal care routinely provided at the family medicine unit without the additional breastfeeding educational intervention.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Exclusive Breastfeeding Rate at 3 Months Postpartum
Tidsramme: 3 months postpartum
|
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
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Guadalupe Aguilar Hernández, MD, INSTITUTO MEXICANO DEL SEGURO SOCIAL, UNIDAD DE MEDICINA FAMILIAR NO. 9
- Studieleder: Sergio Paredes Solis, MD, Centro de Investigación de Enfermedades Tropicales, Universidad Autonoma de Guerrero
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IMSS-UMF-BSES-2026
- R-2026-1101-006 (Registeridentifikator: SIRELCIS)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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