Plain English Summary
Background and study aims
The World Health Organization (WHO) recommends exclusive breastfeeding up to 6 months of age to achieve adequate growth. Despite this recommendation, the exclusive breastfeeding rate at 6 months is low. The aim of this study is to evaluate the impact of breastfeeding support groups in primary health centers in Andalusia, Spain.
Who can participate?
Adult women who have established exclusive or mixed breastfeeding once they attend the postnatal check with their midwife, and who have attended the breastfeeding group session included in their primary health centre's antenatal classes
What does the study involve?
Participants are randomly allocated to the control group or the intervention group. The control group will receive the usual care consisting of group prenatal education on breastfeeding offered by their center. The intervention group will receive the usual care and they will also participate in monthly breastfeeding support sessions reinforced with a WhatsApp and/or Facebook group led by other lactating mothers (peer support) and coordinated by their reference midwife. Measurements will be carried out at 10 days postpartum and after 2, 4 and 6 months to evaluate the rate of breastfeeding using a questionnaire. Factors related to the success of breastfeeding will be identified.
What are the possible benefits and risks of participating?
Participants may breastfeed for longer. Risks are not expected.
Where is the study run from?
This study will run from primary health centers in Andalucia, Spain
When is the study starting and how long is it expected to run for?
January 2020 to January 2023
Who is funding the study?
Consejería de Salud y Familias de la Junta de Andalucia (Spain)
Who is the main contact?
Evaluation of the impact of breastfeeding support groups in primary health centres in Andalusia, Spain: a cluster randomized controlled trial (Galma Project)
Women who attend breastfeeding support groups breastfeed exclusively longer than women who do not attend any support group.
Approved 24/02/2020, Investigation Ethics Committee of the hospitals Virgen Macarena and Virgen del Rocio (c/o Carlos García Pérez, University Hospitals Vírgen Macarena-Virgen del Rocío, Seville, Spain; +34 (0)600 16 24 58; firstname.lastname@example.org), ref: Code1936-N-19
Interventional multicentre cluster randomized clinical trial
Primary study design
Secondary study design
Cluster randomised trial
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
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 centers) by simple random sampling.
Intervention group: participation in monthly breastfeeding support sessions reinforced with a WhatsApp and/or Facebook group led by other lactating mothers (peer support) and coordinated by their reference midwife, follow up every 2 months, and 10 days after birth, follow up through telephone, app or online questionnaire via WhatsApp.
Control group: usual care about breastfeeding: antenatal lessons and follow up in the outpatient clinic.
Measurements will be carried out at the postpartum 10 days, 2, 4 and 6 months to evaluate the rate of breastfeeding using the validated questionnaire of self-efficacy of breastfeeding, general self-efficacy questionnaire and problems identified related to breastfeeding. Factors related to the success of breastfeeding will be identified.
Primary outcome measure
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 outcome measures
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
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant 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
Target number of participants
Target: 511 women. In total, 10 clusters (10 centres in 5 cities). A total of 50 participants should be included in every single cluster.
Participant exclusion criteria
1. HIV positive
3. Tuberculosis infection
4. No intention to breastfeed
5. Impossibility or contraindication to breastfeed due to medical conditions
6. Communication difficulties due to language
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Servicio Andaluz de Salud
Av Constitución, 18
Consejería de Salud y Familias de la Junta de Andalucia
Avenida de la Innovación s/n. Edificio Arena 1
+34 (0)955 006 300
University of Seville
Faculty of Nursing
Physiotherapy and Podiatry. University of Seville (Spain).
Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla
Hospital Universitario Virgen del Rocío. Avda. Manuel Siurot
Edif. de Laboratorios 6º planta.
+34 (0)955 01 32 84
Consejería de Salud y Familias de la Junta de Andalucia
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
1. Publication of protocol in June 2020
2. Publication of preliminary results in 2021
3. Publication of main results in 2022
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Fátima León-Larios (email@example.com). The database will be available during 2022 when the study is finished. Data will be anonymous and will be able to be used for scientific purposes.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
2020 protocol in https://pubmed.ncbi.nlm.nih.gov/32682408/ (added 21/07/2020)