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?
Fatima Leon-Larios
fatimaleon@us.es
Trial website
Contact information
Type
Public
Primary contact
Dr Fatima Leon-Larios
ORCID ID
https://orcid.org/0000-0001-9475-0440
Contact details
Avenzoar
6
Seville
41009
Spain
+34 (0)954556097
fatimaleon@us.es
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
08/2019 project
Study information
Scientific title
Evaluation of the impact of breastfeeding support groups in primary health centres in Andalusia, Spain: a cluster randomized controlled trial (Galma Project)
Acronym
Galma Project
Study hypothesis
Women who attend breastfeeding support groups breastfeed exclusively longer than women who do not attend any support group.
Ethics approval
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; administracion.eecc.hvm.sspa@juntadeandalucia.es), ref: Code1936-N-19
Study design
Interventional multicentre cluster randomized clinical trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Community
Trial type
Other
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Breastfeeding
Intervention
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.
Intervention type
Behavioural
Phase
Drug names
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
01/01/2020
Overall trial end date
01/01/2023
Reason abandoned (if study stopped)
Eligibility
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
Participant type
Healthy volunteer
Age group
Adult
Gender
Female
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
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
Recruitment start date
01/03/2021
Recruitment end date
01/03/2022
Locations
Countries of recruitment
Spain
Trial participating centre
Servicio Andaluz de Salud
Av Constitución, 18
Seville
41071
Spain
Sponsor information
Organisation
Consejería de Salud y Familias de la Junta de Andalucia
Sponsor details
Avenida de la Innovación s/n. Edificio Arena 1
Sevilla
41020
Spain
+34 (0)955 006 300
consejero.csafa@juntadeandalucia.es
Sponsor type
Government
Website
https://www.juntadeandalucia.es/organismos/saludyfamilias.html
Organisation
University of Seville
Sponsor details
Faculty of Nursing
Physiotherapy and Podiatry. University of Seville (Spain).
C/Avenzoar
6
Seville
41009
Spain
+34 (0)854556097
decanatoefp@us.es
Sponsor type
University/education
Website
Organisation
Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla
Sponsor details
Hospital Universitario Virgen del Rocío. Avda. Manuel Siurot
s/n.
Edif. de Laboratorios 6º planta.
Seville
41013
Spain
+34 (0)955 01 32 84
mariap.alarcon@juntadeandalucia.es
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
Consejería de Salud y Familias de la Junta de Andalucia
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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 (fatimaleon@us.es). 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
31/12/2022
Participant level data
Available on request
Basic results (scientific)
Publication list
2020 protocol in https://pubmed.ncbi.nlm.nih.gov/32682408/ (added 21/07/2020)