BreastfeedingNCT01474096
Implementation Strategy for a Breastfeeding Guideline in Primary Care
A study testing implementation strategy of Breastfeeding in people with Breastfeeding, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.
Trial summary
The purpose of this study is to determine whether an implementation strategy for a breastfeeding guide is more effective than the usual practice (simple circulation of the guide) in terms of increasing the percentage of children receiving exclusive or preferential breastfeeding at 6 months age. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- implementation strategy of Breastfeeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2010to Dec 2012
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mothers of children born during the study period (6 months)
- Mothers who come to the health centre on 1st visit (child attention programme)
- Mothers who give their consent to participate.
Who cannot join
- Breastfeeding Contraindications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Implementation Strategy for a Breastfeeding Guideline in Primary Care: Cluster Randomised Trial
The purpose of this study is to determine whether an implementation strategy for a breastfeeding guide is more effective than the usual practice (simple circulation of the guide) in terms of increasing the percentage of children receiving exclusive or preferential breastfeeding at 6 months age.
Read the detailed description
Protection and promotion of breastfeeding is considered a priority in Europe where only 22% of children less than 6 months old are exclusively breastfed. In Spain this percentage reaches 24.8% but in our city it falls to 18.26%. Various studies emphasise that the improvement of these results falls upon the training of health professionals. Following the recommendations of a breastfeeding guide can modify professional practice and improve results with respect to patients.
Aim:to determine whether an implementation strategy for a breastfeeding guide is more effective than the usual practice (simple circulation of the guide) in terms of increasing the percentage of children receiving exclusive or preferential breastfeeding at 6 months age.
Method/Design: The present work involves a community, clinical trial, randomised by clusters in Primary Health Care Centres in Madrid Region (Spain). The project aims at determining whether the use of implementation strategy (including training session, information distribution, an opinion leader) of Breastfeeding CPG in primary care is more effective than the usual practice of mere circulation.
Number of patients required will be 240 (n=120 in the intervention group and control group), all mothers of children born during the study period (6 months), who come to the health centre on the first visit of child attention programme and give their consent to participate.
The main outcome variable is age at which breastfeeding ceases; secondary outcome variables include sex, age, educational level.
Analysis of main effectiveness will be done, comparing the proportion of patients with breastfeeding completed at 6 months in the two study groups. All statistical tests will be performed with intention to treat. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis.
- Conditions
- Breastfeeding
- Being tested
- implementation strategy of Breastfeeding
- Keywords
- clinical practice guideline-primary health care
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implementation strategy of BreastfeedingOther
Also called breastfeeding, clinical practice guideline, primary health care
implementation strategy (including training session, information distribution, an opinion leader) of Breastfeeding
| Study group | Role | What they receive |
|---|---|---|
| implementation strategy | Experimental | determining whether the use of implementation strategy (including training session, information distribution, an opinion leader) of Breastfeeding CPG in primary care is more effective than the usual practice of mere circulation. Receives: Other: implementation strategy of Breastfeeding |
| Conventional intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients with breastfeeding completed at 6 months
Analysis of main effectiveness will be done, comparing the proportion of patients with breastfeeding completed at 6 months in the two study groups
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2011 (estimated)
- Study startJan 2010
- Primary completionDec 2012
- Study completionDec 2012
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 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 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
- Susana Martin, Nurse, Principal investigator, Gerencia Atención Primaria. Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474096
- Sponsor's protocol ID
- 08/90680
- Status last verified
- Apr 2015
- First submitted
- 4 Nov 2011
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gavine A, Shinwell SC, Buchanan P, Farre A, Wade A, Lynn F, Marshall J, Cumming SE, Dare S, McFadden A. Support for healthy breastfeeding mothers with healthy term babies. Cochrane Database Syst Rev. 2022 Oct 25;10(10):CD001141. doi: 10.1002/14651858.CD001141.pub6.
PubMed 36282618Martin-Iglesias S, del-Cura-Gonzalez I, Sanz-Cuesta T, Arana-Canedo Arguelles C, Rumayor-Zarzuelo M, Alvarez-de la Riva M, Lloret-Saez Bravo AM, Fernandez-Arroyo RM, Arejula-Torres JL, Aguado-Arroyo O, Gongora-Maldonado F, Garcia-Corraliza M, Sandoval-Encinas N, Tomico-delRio M, Cornejo-Gutierrez AM. Effectiveness of an implementation strategy for a breastfeeding guideline in Primary Care: cluster randomised trial. BMC Fam Pract. 2011 Dec 30;12:144. doi: 10.1186/1471-2296-12-144.
PubMed 22208800
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Implementation Strategy for a Breastfeeding Guideline in Primary Care: Cluster Randomised Trial
- ClinicalTrials.gov ID
- NCT01474096
- Acronym / sponsor ID
- 08/90680
- Conditions
- Breastfeeding
- Keywords
- clinical practice guideline-primary health care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Gerencia de Atención Primaria, MadridOther government
- Study start
- Jan 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 18 Nov 2011 (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.
The purpose of this study is to determine whether an implementation strategy for a breastfeeding guide is more effective than the usual practice (simple circulation of the guide) in terms of increasing the percentage of children receiving exclusive or preferential breastfeeding at 6 months age.
Detailed description
Protection and promotion of breastfeeding is considered a priority in Europe where only 22% of children less than 6 months old are exclusively breastfed. In Spain this percentage reaches 24.8% but in our city it falls to 18.26%. Various studies emphasise that the improvement of these results falls upon the training of health professionals. Following the recommendations of a breastfeeding guide can modify professional practice and improve results with respect to patients.
Aim:to determine whether an implementation strategy for a breastfeeding guide is more effective than the usual practice (simple circulation of the guide) in terms of increasing the percentage of children receiving exclusive or preferential breastfeeding at 6 months age.
Method/Design: The present work involves a community, clinical trial, randomised by clusters in Primary Health Care Centres in Madrid Region (Spain). The project aims at determining whether the use of implementation strategy (including training session, information distribution, an opinion leader) of Breastfeeding CPG in primary care is more effective than the usual practice of mere circulation.
Number of patients required will be 240 (n=120 in the intervention group and control group), all mothers of children born during the study period (6 months), who come to the health centre on the first visit of child attention programme and give their consent to participate.
The main outcome variable is age at which breastfeeding ceases; secondary outcome variables include sex, age, educational level.
Analysis of main effectiveness will be done, comparing the proportion of patients with breastfeeding completed at 6 months in the two study groups. All statistical tests will be performed with intention to treat. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| implementation strategy | Experimental | Other: implementation strategy of Breastfeedingdetermining whether the use of implementation strategy (including training session, information distribution, an opinion leader) of Breastfeeding CPG in primary care is more effective than the usual practice of mere circulation. |
| Conventional intervention | No intervention | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Mothers of children born during the study period (6 months)
- Mothers who come to the health centre on 1st visit (child attention programme)
- Mothers who give their consent to participate.
Key exclusion criteria (1 listed)
- Breastfeeding Contraindications
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 |
|---|---|---|
| implementation strategy of BreastfeedingAlso: breastfeeding, clinical practice guideline, primary health careimplementation strategy (including training session, information distribution, an opinion leader) of Breastfeeding | Other | implementation strategy |
Primary outcome
proportion of patients with breastfeeding completed at 6 months
Time frame: 6 months
Analysis of main effectiveness will be done, comparing the proportion of patients with breastfeeding completed at 6 months in the two study groups
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 9 Apr 2015.
- Derived from this study: PubMed 36282618Gavine A, Shinwell SC, Buchanan P, Farre A, Wade A, Lynn F, Marshall J, Cumming SE, Dare S, McFadden A. Support for healthy breastfeeding mothers with healthy term babies. Cochrane Database Syst Rev. 2022 Oct 25;10(10):CD001141. doi: 10.1002/14651858.CD001141.pub6.
- Derived from this study: PubMed 22208800Martin-Iglesias S, del-Cura-Gonzalez I, Sanz-Cuesta T, Arana-Canedo Arguelles C, Rumayor-Zarzuelo M, Alvarez-de la Riva M, Lloret-Saez Bravo AM, Fernandez-Arroyo RM, Arejula-Torres JL, Aguado-Arroyo O, Gongora-Maldonado F, Garcia-Corraliza M, Sandoval-Encinas N, Tomico-delRio M, Cornejo-Gutierrez AM. Effectiveness of an implementation strategy for a breastfeeding guideline in Primary Care: cluster randomised trial. BMC Fam Pract. 2011 Dec 30;12:144. doi: 10.1186/1471-2296-12-144.
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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.
Susana Martin, Nurse principal investigator
Gerencia 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 implementation strategy of Breastfeeding in people with 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 1 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 9 Apr 2015. 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?
proportion of patients with breastfeeding completed at 6 months (time frame: 6 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 NCT01474096, 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 9 Apr 2015.