Evaluation of the impact of breastfeeding support groups in primary health centers in Andalusia, Spain
| ISRCTN | ISRCTN17263529 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17263529 |
| Secondary identifying numbers | 08/2019 project |
- Submission date
- 20/05/2020
- Registration date
- 17/06/2020
- Last edited
- 04/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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 December 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
Contact information
Public
Avenzoar, 6
Seville
41009
Spain
 ORCID ID |
0000-0001-9475-0440 |
|---|---|
| Phone | +34 (0)954556097 |
| fatimaleon@us.es |
Study information
| Study design | Interventional multicentre cluster randomized clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Evaluation of the impact of breastfeeding support groups in primary health centres in Andalusia, Spain: a cluster randomized controlled trial (Galma Project) |
| Study acronym | Galma Project |
| Study objectives | Women who attend breastfeeding support groups breastfeed exclusively longer than women who do not attend any support group. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2020 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Target: 371 women. In total, 10 clusters (10 centres in 5 cities). |
| Total final enrolment | 382 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2021 |
| Date of final enrolment | 01/12/2023 |
Locations
Countries of recruitment
- Spain
Study participating centre
Seville
41071
Spain
Sponsor information
Government
Avenida de la Innovación s/n. Edificio Arena 1
Sevilla
41020
Spain
| Phone | +34 (0)955 006 300 |
|---|---|
| consejero.csafa@juntadeandalucia.es | |
| Website | https://www.juntadeandalucia.es/organismos/saludyfamilias.html |
University/education
Faculty of Nursing, Physiotherapy and Podiatry. University of Seville (Spain).
C/Avenzoar, 6
Seville
41009
Spain
| Phone | +34 (0)854556097 |
|---|---|
| decanatoefp@us.es | |
| Website | http://www.us.es/eng |
"ROR" |
https://ror.org/03yxnpp24 |
Research organisation
Hospital Universitario Virgen del Rocío. Avda. Manuel Siurot, s/n., Edif. de Laboratorios 6º planta.
Seville
41013
Spain
| Phone | +34 (0)955 01 32 84 |
|---|---|
| mariap.alarcon@juntadeandalucia.es | |
| Website | http://fisevi.com/ |
|
"ROR" |
https://ror.org/01bp61317 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/03/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Publication of protocol 2. Publication of preliminary results 3. Publication of main results |
| IPD sharing plan | 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 when the study is finished. Data will be anonymous and will be able to be used for scientific purposes. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 18/07/2020 | 21/07/2020 | Yes | No |
| Results article | 28/03/2024 | 04/04/2024 | Yes | No |
Editorial Notes
04/04/2024: Publication reference added.
05/12/2023: The following changes were made to the trial record:
1. The overall end date was changed from 01/06/2023 to 31/12/2023.
2. The target number of participants was changed from 511 to 371.
3. The total final enrolment was added.
04/03/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/03/2022 to 01/12/2023.
2. The overall end date was changed from 01/01/2023 to 01/06/2023.
3. The intention to publish date was changed from 31/12/2022 to 01/03/2024.
4. The plain English summary was updated to reflect these changes.
01/03/2021: The recruitment start date was changed from 01/03/2021 to 01/10/2021.
09/09/2020: The recruitment start date has been changed from 01/09/2020 to 01/03/2021.
21/07/2020: Publication reference added.
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.
