Exclusive BreastfeedingPROLACTNCT01869920
Effectiveness of an Educational Intervention to Maintain Exclusive Breastfeeding
A study testing Intervention group in people with Exclusive Breastfeeding, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.
Trial summary
Hypothesis: An educational intervention increases the proportion of mother-infant pairs using exclusive breastfeeding Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Exclusive Breastfeeding
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 434 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female 18 years old or older,
- mother-infant pairs using exclusive breastfeeding,
- Signed Informed Consent
Who cannot join
- Any medical conditions that prevents breastfeeding
- infant should be not older than four weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an Educational Group Intervention in Primary Care to Maintain Exclusive Breastfeeding. Cluster Randomised Clinical Trial. PROLACT Study.
Hypothesis: An educational intervention increases the proportion of mother-infant pairs using exclusive breastfeeding
Read the detailed description
Objective: Evaluate the effectiveness of an educational group intervention performed by primary healthcare professionals in terms of increasing the proportion of mother-infant pairs using exclusive breastfeeding at six months compared to routine practice. Design: cluster randomized trial. Setting: Multicentre. Primary Care Health Centres (PCHC). Madrid. Subjects: mother-infant pairs using exclusive breastfeeding who come for any query to the health centre, as long as the infant is not older than four weeks and who consent to participate in the study.
Sample size: N= 432 (216 in each arm). Randomisation: Unit of randomization: primary healthcare centres.
Analysis unit: mother-infant pairs, recruitment to consecutive sampling. Intervention: Educational group intervention in the treatment group and the usual intervention in the control group.
Variables: Main response variable: mother-infant pairs using exclusive breastfeeding (EBF) at six months. Secondary variables: type of breastfeeding at 6 months, duration of EBF, reasons for ceasing breastfeeding, satisfaction with the intervention (SERVQUAL). Prognostic variables: infant, mother and professional.
Data Analysis: Analysis of main effectiveness by intention to treat, comparing the proportion of mother-infant pairs using EBF at six months in both groups. The estimation adjusted using an explanatory logistics regression model. To assess the effect of the educational group intervention on the duration of the various type of breastfeeding, a survival analysis will be used comparing the two groups using the log-rank test. The control of potential confounding variables will be performed by the construction of various Cox regression models.
- Conditions
- Exclusive Breastfeeding
- Being tested
- Intervention group, Usual care
- Keywords
- breastfeeding, education, intervention
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupBehavioural
Education on breastfeeding
Usual careBehavioural
Usual care
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Intervention group receive a training education on breastfeeding. Education training is provided by an expert group from General Direction of Primary Care Receives: Behavioral: Intervention group |
| Controll group | Other | Usual care Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exclusive breastfeeding (EBF)
Evaluate the presence of EBF 6 months after educational intervention.
Measured: six months
Secondary outcomes (2)
Type of breastfeeding and duration of EBF
EBF or not exclusive breastfeeding and duration in months
Measured: Six months
breastfeeding ceasing
Reasons for breastfeeding ceasing
Measured: During follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startFeb 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Exclusive BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 434 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gerencia de Atención Primaria, Madrid
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Susana Martín Iglesias, Gerencia de Atención Primaria, Madrid
- Investigators
- María J Santamaría, Nurse, Principal investigator, Gerencia de Atención Primaria, MadridSusana Martín, Nurse, Principal investigator, Gerencia de Atención Primaria, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869920
- Sponsor's protocol ID
- PI12/02609_PI12/02020
- Acronym
- PROLACT
- Status last verified
- Aug 2017
- First submitted
- 3 Jun 2013
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Santamaria-Martin MJ, Martin-Iglesias S, Schwarz C, Rico-Blazquez M, Portocarrero-Nunez JA, Diez-Izquierdo L, Llamosas-Falcon L, Rodriguez-Barrientos R, Del-Cura-Gonzalez I; Grupo PROLACT. Effectiveness of a group educational intervention - prolact - in primary care to promote exclusive breastfeeding: a cluster randomized clinical trial. BMC Pregnancy Childbirth. 2022 Feb 16;22(1):132. doi: 10.1186/s12884-022-04394-8.
PubMed 35172775Martin-Iglesias S, Santamaria-Martin MJ, Alonso-Alvarez A, Rico-Blazquez M, Del Cura-Gonzalez I, Rodriguez-Barrientosn R, Barbera-Martin A, Sanz-Cuesta T, Isabel Coghen-Vigueras M, de Antonio-Ramirez I, Durand-Rincon I, Garrido-Rodriguez F, Geijo-Rincon MJ, Mielgo-Salvador R, Morales-Montalva MS, Reviriego-Gutierrez MA, Rivero-Garrido C, Ruiz-Calabria M, Santamaria-Mechano MP, Santiago-Fernandez R, Sillero-Quintana MI, Soto-Almendro B, Terol-Claramonte M, Villa-Arranz M. Effectiveness of an educational group intervention in primary healthcare for continued exclusive breast-feeding: PROLACT study. BMC Pregnancy Childbirth. 2018 Feb 26;18(1):59. doi: 10.1186/s12884-018-1679-3.
PubMed 29482516
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Educational Group Intervention in Primary Care to Maintain Exclusive Breastfeeding. Cluster Randomised Clinical Trial. PROLACT Study.
- ClinicalTrials.gov ID
- NCT01869920
- Acronym / sponsor ID
- PROLACT / PI12/02609_PI12/02020
- Conditions
- Exclusive Breastfeeding
- Keywords
- breastfeeding, education, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 434 participants (actual)
- Lead sponsor
- Gerencia de Atención Primaria, MadridOther government
- Study start
- Feb 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 5 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis: An educational intervention increases the proportion of mother-infant pairs using exclusive breastfeeding
Detailed description
Objective: Evaluate the effectiveness of an educational group intervention performed by primary healthcare professionals in terms of increasing the proportion of mother-infant pairs using exclusive breastfeeding at six months compared to routine practice. Design: cluster randomized trial. Setting: Multicentre. Primary Care Health Centres (PCHC). Madrid. Subjects: mother-infant pairs using exclusive breastfeeding who come for any query to the health centre, as long as the infant is not older than four weeks and who consent to participate in the study.
Sample size: N= 432 (216 in each arm). Randomisation: Unit of randomization: primary healthcare centres.
Analysis unit: mother-infant pairs, recruitment to consecutive sampling. Intervention: Educational group intervention in the treatment group and the usual intervention in the control group.
Variables: Main response variable: mother-infant pairs using exclusive breastfeeding (EBF) at six months. Secondary variables: type of breastfeeding at 6 months, duration of EBF, reasons for ceasing breastfeeding, satisfaction with the intervention (SERVQUAL). Prognostic variables: infant, mother and professional.
Data Analysis: Analysis of main effectiveness by intention to treat, comparing the proportion of mother-infant pairs using EBF at six months in both groups. The estimation adjusted using an explanatory logistics regression model. To assess the effect of the educational group intervention on the duration of the various type of breastfeeding, a survival analysis will be used comparing the two groups using the log-rank test. The control of potential confounding variables will be performed by the construction of various Cox regression models.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Intervention groupIntervention group receive a training education on breastfeeding. Education training is provided by an expert group from General Direction of Primary Care |
| Controll group | Other | Behavioral: Usual careUsual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female 18 years old or older,
- mother-infant pairs using exclusive breastfeeding,
- Signed Informed Consent
Key exclusion criteria (2 listed)
- Any medical conditions that prevents breastfeeding
- infant should be not older than four weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention groupEducation on breastfeeding | Behavioural | intervention group |
| Usual careUsual care | Behavioural | Controll group |
Primary outcome
Exclusive breastfeeding (EBF)
Time frame: six months
Evaluate the presence of EBF 6 months after educational intervention.
2 secondary outcomes
Type of breastfeeding and duration of EBF
Time frame: Six months
breastfeeding ceasing
Time frame: During follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Derived from this study: PubMed 35172775Santamaria-Martin MJ, Martin-Iglesias S, Schwarz C, Rico-Blazquez M, Portocarrero-Nunez JA, Diez-Izquierdo L, Llamosas-Falcon L, Rodriguez-Barrientos R, Del-Cura-Gonzalez I; Grupo PROLACT. Effectiveness of a group educational intervention - prolact - in primary care to promote exclusive breastfeeding: a cluster randomized clinical trial. BMC Pregnancy Childbirth. 2022 Feb 16;22(1):132. doi: 10.1186/s12884-022-04394-8.
- Derived from this study: PubMed 29482516Martin-Iglesias S, Santamaria-Martin MJ, Alonso-Alvarez A, Rico-Blazquez M, Del Cura-Gonzalez I, Rodriguez-Barrientosn R, Barbera-Martin A, Sanz-Cuesta T, Isabel Coghen-Vigueras M, de Antonio-Ramirez I, Durand-Rincon I, Garrido-Rodriguez F, Geijo-Rincon MJ, Mielgo-Salvador R, Morales-Montalva MS, Reviriego-Gutierrez MA, Rivero-Garrido C, Ruiz-Calabria M, Santamaria-Mechano MP, Santiago-Fernandez R, Sillero-Quintana MI, Soto-Almendro B, Terol-Claramonte M, Villa-Arranz M. Effectiveness of an educational group intervention in primary healthcare for continued exclusive breast-feeding: PROLACT study. BMC Pregnancy Childbirth. 2018 Feb 26;18(1):59. doi: 10.1186/s12884-018-1679-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María J Santamaría, Nurse principal investigator
Gerencia de Atención Primaria, Madrid
Susana Martín, Nurse principal investigator
Gerencia de Atención Primaria, Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Exclusive Breastfeeding, run by Gerencia de Atención Primaria, Madrid 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 2 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: finished, as of the sponsor's last update on 22 Aug 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exclusive breastfeeding (EBF) (time frame: six months). 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 NCT01869920, which also lists 2 linked publications.
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 22 Aug 2017.