AzTrials
AzTrials

Growth & DevelopmentALM-APNCT07309510

Effectiveness of a Counseling Program on Exclusive Breastfeeding Rates in a Primary Care Center

A study testing breastfeeding counseling in people with Growth & Development and Breastfeeding Satisfaction, run by Fundación Pública Galega de Investigación Biomédica INIBIC at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Introduction: Evidence supports that exclusive breastfeeding (EBF) is the most beneficial method of infant feeding up to 6 months of age. The practice confers numerous advantages for the infant and the mother. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
breastfeeding counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteSpain
Study dates
1 Feb 2026to Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Mothers who express a desire to breastfeed during a follow-up consultation with the Obstetric and Gynecological Nursing or Physician specialist at 36 weeks of gestation.
  • Mothers who plan to give birth at HMI of CHUAC, referred from the C.S. Ventorrillo.
  • Women who are fluent in Spanish or Galician.

Who cannot join

  • Maternal age under 18 years - Maternal use of drugs or medication that prevent breastfeeding .
  • Maternal infection with HIV or Human T-cell Leukemia Virus.
  • Mothers of newborns with cow's milk protein allergy, galactosemia, or congenital primary lactase deficiency.
  • Participate in other clinical trials.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yolanda suarez Sánchez Suárez contact

+34981142850

yolanda.sanchez.suarez2@sergas.es

Carmen Neri Fernández Pombo, PhD contact

carmen.neri.fernandez.pombo@col.udc.es

Spain1 site, 1 recruiting

  • Centro de Salud de O Ventorrillo

    A Coruña, Galicia

    Yolanda Sánchez Suárez, 981178000, yolanda.sanchez.suarez2@sergas.es

    Yolanda Sánchez Suárez

    Recruiting

Other trials in Spain

About this study

Official title: Effectiveness of a Counseling Program on Exclusive Breastfeeding Rates in a Primary Care Center in A Coruña.Randomized Controlled Clinical Trial

Introduction: Evidence supports that exclusive breastfeeding (EBF) is the most beneficial method of infant feeding up to 6 months of age. The practice confers numerous advantages for the infant and the mother. Many breasfeeding are abandoned early due difficulties experienced after dischargue and after returning to work. Development specific early breastfeeding support programs in the community is necessary to avoid unwanted abandonment.

Objective: To analyse the differences in BF rates at six month of birth in healthy full-term newborns between the study groups.

Methodology: Pilot study of a randomised clinical trial carried out in a Paediatric Nursing clinic at the Ventorrillo Health Centre in A Coruña. The study population will be mothers of healthy full-term newborns who wish to give BF at the time of delivery and whose reference health centre is the one of the study. The mother- newborn dyads in the control group (CG) will receive the usual care described in the child health Program of the Galician Health Service, and the dyads included in the intervention group (IG) will also receive specific advice on breastfeeding during the first 6 months of life. A study sample of 80 participants is estimated for each group. The study will be approved by the Research Ethics Committee of A Coruña-Ferrol. The variables under study will be collected in a data collection notebook for later statistical analysis. A significant value of p < 0.05 being considered.

Being tested
breastfeeding counseling
Keywords
Breastfeeding, Infant, Human Milk, Health Education, Primary Health Care, Postpartum Period
Medical subject headings
Breast Feeding, Health Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • breastfeeding counselingBehavioural

    The intervention group will receive, in addition to the indicated conventional care, 4 scheduled breastfeeding counseling appointments, the first of which will take place within the first 72 hours after hospital discharge following birth. As part of the breastfeeding counseling, the Latch scale will be used to observe and assess breastfeeding sessions, the breastfeeding self-efficacy scale-short (BSES-SF) to evaluate breastfeeding self-efficacy, the Visual Analogue Scale (VAS) to evaluate pain related to breastfeeding, and the breastfeeding clinical record form from the World Health Organization (WHO). Training will be provided to the mother and family on pre-selected breastfeeding topics. Mothers will be able to contact the IP nurse by phone daily on demand from 10 a.m. to 3 p.m.

Study groups in NCT07309510
Study groupRoleWhat they receive
Conventional careNo interventionConventional care within the Child Health Program (SERGAS) The health program includes 5 appointments with the Pediatric Specialist doctor and the Pediatric Specialist nurse in the first 6 months of life. These appointments will take place at 7-15 days, at 1 month, at 2 months, at 4 months, and at 6 months of age.
breastfeeding counselingExperimentalNot described
Receives: Behavioral: breastfeeding counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of exclusive breastfeeding at 6 months of age of the newborn

    The practice of feeding the infant exclusively with breast milk from 0 to 5 months (without giving any other food or drink, not even water). Nursing by a wet nurse, feeding with expressed breast milk, and feeding with breast milk from donors are also considered breastfeeding.

    Measured: From birth up to 6 months of the infant's life

Secondary outcomes (11)

  1. Number of participants with exclusive breastfeeding at 15 days, one month, and three months of the newborn's life.

    Defined as the practice of feeding the infant exclusively with breast milk (without giving any other food or drink, not even water). Breastfeeding by a wet nurse, feeding with expressed breast milk, and feeding with donor breast milk are also considered breastfeeding.

    Measured: At 15 days, one month, and three months of the newborn's life.

  2. Number of participants with recovery to birth weight

    The infant regains the weight with which they were born

    Measured: At 15 days and one month of age

  3. Grams of daily weight gain

    Grams of weight gained per day since the previous weight check.

    Measured: At 15 days, 1 month, 2 months, 4 months and 6 months of the infant's life

  4. Age of introduction of complementary feeding

    Age of the infant at which complementary feeding is started in both study groups.

    Measured: From birth to 6 months of age

  5. Number of Hospital admissions by the newborn

    Hospital admissions by the newborn in both study groups.

    Measured: From birth to 6 months of age

  6. Number of emergency department visits by the newborn

    number and reason for emergency department visits by the newborn in both study groups.

    Measured: From birth to 6 months of age

  7. Number of visits by the pediatric nurse specialist

    Number and reason for visits by the pediatric nurse specialist in both study groups.

    Measured: Until completion of the study (6 months after birth)

  8. Number of visits to the specialist nurse in Obstetric-Gynecological Nursing

    Number of visits to the specialist nurse in Obstetric-Gynecological Nursing

    Measured: Until completion of the study (6 months after birth)

  9. Days after birth of cessation of breastfeeding

    Days of the infant's life when the last breastfeeding is administered

    Measured: Until completion of the study (6 months after birth)

  10. Score on the validated scale of impact of support networks in breastfeeding

    Score on the validated scale of impact of support networks in breastfeeding Validated scale of the impact of support networks on breastfeeding. Composed of 12 items, self-administered. Mothers must indicate their level of agreement or disagreement with the statements using a 5-point Likert scale. The maximum score is 60 points and the minimum is 12 points. A higher score indicates a greater degree of satisfaction or perceived quality among users of breastfeeding support services.

    Measured: 6 months after birth or when the mother abandons the study

  11. Score of Maternal Breastfeeding Evaluation Scale (MBFES-E)

    Score on the Spanish version of the Maternal Breastfeeding Evaluation Scale (MBFES-E). A 5-point Likert-type scale is used in which the participant rates their level of agreement with the item statement (1: strongly disagree to 5: strongly agree). The final score on the scale will range from 30 to 150 and is interpreted such that a higher score indicates greater satisfaction with the breastfeeding experience.

    Measured: 6 months after birth or when the mother abandons the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2025
  2. Study start1 Feb 2026
  3. Primary completionAug 2027 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07309510
Sponsor's protocol ID
2025/235
Other IDs
2025/235
Acronym
ALM-AP
Status last verified
Sep 2026
First submitted
19 Nov 2025
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing breastfeeding counseling in people with Growth & Development and Breastfeeding Satisfaction, run by Fundación Pública Galega de Investigación Biomédica INIBIC at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yolanda suarez Sánchez Suárez (+34981142850, yolanda.sanchez.suarez2@sergas.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of exclusive breastfeeding at 6 months of age of the newborn (time frame: From birth up to 6 months of the infant's life). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07309510.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in