Condition category
Not Applicable
Date applied
20/05/2020
Date assigned
17/06/2020
Last edited
17/06/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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

01/09/2020

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

http://www.us.es/eng

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

http://fisevi.com/

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

Publication citations

Additional files

Editorial Notes

17/06/2020: Internal review. 21/05/2020: Trial's existence confirmed by Investigation Ethics Committee of the hospitals Virgen Macarena and Virgen del Rocio.