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Evaluation of the impact of breastfeeding support groups in primary health centers in Andalusia, Spain

Evaluation of the impact of breastfeeding support groups in primary health centres in Andalusia, Spain: a cluster randomized controlled trial (Galma Project)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17263529
Enrollment
371
Registered
2020-06-17
Start date
2021-10-01
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding Other

Interventions

Participants will be randomized without blinding due to the impossibility of achieving it with patients or researchers (open, masking not used). Women will be allocated by clusters (primary health cen

Sponsors

Consejería de Salud y Familias de la Junta de Andalucia
Lead Sponsor
University of Seville
Collaborator
Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Healthy women with exclusive or mixed breastfeeding 10 days after birth, and attended antenatal lessons in the Primary Health Centre 2. Women over 18 years of age 3. Women who accepted and signed the informed consent

Exclusion criteria

Exclusion criteria: 1. HIV positive 2. Cancer 3. Tuberculosis infection 4. No intention to breastfeed 5. Impossibility or contraindication to breastfeed due to medical conditions 6. Communication difficulties due to language

Design outcomes

Primary

MeasureTime frame
Percentage of exclusive breastfeeding, mixed breastfeeding, or formula, measured using study app or online questionnaire completed by the mother at 10 days after birth, 2, 4, 6 months after birth

Secondary

MeasureTime frame
1. Sociodemographic outcomes (mother's age, level of education, marital status, employment status, country of origin) measured with closed-ended questions using study app or online questionnaire completed by the mother and the midwife before birth 2. Breastfeeding self-efficacy assessed using breastfeeding self-efficacy scale-short form (Spanish Version) at baseline (10 days after birth), 2, 4, 6 months after birth 3. A breastfeeding observation assessed using WHO Breastfeeding assessment tool at 10 days after birth 4. Breastfeeding self-efficacy assessed using General Self-efficacy scale (Spanish Version) at 10 days, 2, 4, 6 months after birth 5. Motivation for interruption of breastfeeding assessed with open-ended questions completed by the mother using study app or online questionnaire at 2, 4, 6 months after birth 6. Problems related to breastfeeding measured by open-ended questions completed by the mother using study app or online questionnaire at 2, 4, 6 months after birth 7. Obstetric outcomes (type of birth, type of onset of labour, type of analgesia used, perineal trauma, skin-to-skin technique) measured by closed-ended questions completed by the mother using study app or online questionnaire at 10 days after birth

Countries

Spain

Contacts

Public ContactFatima Leon-Larios
fatimaleon@us.es+34 (0)954556097

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 26, 2026