Breast FeedingNCT02186613
Telephone Support From Primary Care for Breastfeeding Mothers
A study testing Telephone support in people with Breast Feeding, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
The investigators will conduct a telephone-based support to breastfeeding women with healthy newborns to improve breastfeeding outcomes. 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
- Breast Feeding
- What is being tested?
- Telephone support
- 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
- Oct 2014to Mar 2016
- 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
- Mothers with healthy newborns
- 37 weeks gestation or greater
- Exclusive breastfeeding or any breastfeeding when arrive at Primary Care
Who cannot join
- Infant or mother admitted in ICU
- Twin pregnancy
- Major congenital malformation of babies
- Mothers age <= 18
- Inability to understand Spanish/Catalan
- Mothers who don't have a telephone
- Mothers who don't give her consent
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Jordi Gol i Gurina Foundation
Barcelona, Barcelona, 08007
Josep Balaguer Marinez, Doctor, 34-93-4712000 ext. 509, jbalaguer@ambitcp.catsalut.net
Josep Balaguer Martinez, Doctor
About this study
Official title: Telephone Support From Primary Care to Breastfeeding Mothers: A Randomized and Multicenter Clinical Trial
The investigators will conduct a telephone-based support to breastfeeding women with healthy newborns to improve breastfeeding outcomes.
Read the detailed description
The World Health Organization recommends exclusive breastfeeding to infants until 6 months of age in order to achieve optimum growth. The proportion of exclusive breastfeeding mothers at 6 months is only 24.7 in Spain. The investigators believe it is important to increase the proportion of breastfeeding mothers in their population. Therefore, the investigators have developed a telephonic support protocol for mothers. The intervention will be performed by pediatric nurses in Primary Care.
The main aim of this study is to evaluate in a randomized controlled trial the effectiveness of telephone-based breastfeeding support in exclusive breastfeeding. The secondary aim is to evaluate the effectiveness of the telephonic support in any breastfeeding.
The investigators hypothesis is that this intervention will increase exclusive breastfeeding and any breastfeeding rates.
The study will be carried out in Cornellà, a semi-urban area near Barcelona. Participants will include breastfeeding women who have full-term healthy infants. Mothers will be recruited upon their first arrival to Primary Care from hospital. Eligible mothers who consent to participate will be randomized into either the intervention group or the control group. The latter will receive standard postpartum care. The former will receive standard postpartum care, plus a weekly telephone call during the first two months and every 2 weeks thereafter between the second and the sixth month. The pediatric nurse responsible for monitoring the standard care of each and every patient will be the one responsible for contacting them via telephone. Therefore, the study is not blinded.
The evolution of exclusive breastfeeding will be compared to artificial or supplemented feeding at 1, 2, 4 and 6 months. The effect of the intervention on breastfeeding supplemented with formula will also be valued. Classification into breastfeeding categories is based on 24-hour dietary recall.
- Conditions
- Breast Feeding
- Being tested
- Telephone support
- Keywords
- Breast Feeding, Telephone, Education, 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.
Telephone supportBehavioural
Telephone support intervention to improve breastfeeding rates. The intervention will consist in weekly calls during the first two months and every two weeks between the second and the sixth month. The intervention will be done by pediatric nurses and we have developed a protocol of important issues to deal depending on the age of the baby.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | These mothers and their babies will receive Primary Care standard care (office visits at 1, 2, 4 and 6 months) plus the telephone support Receives: Behavioral: Telephone support |
| No intervention | No intervention | Standard care (office visits at 1, 2, 4 and 6 months) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of exclusive breastfeeding
Exclusive breastfeeding at 6 months. (time frame: 6 months)
Measured: 6 months
Secondary outcomes (3)
Rate of exclusive breastfeeding
Exclusive Breastfeeding at 4 months. (time frame: 4 months)
Measured: 4 months
Rate of exclusive breastfeeding
Exclusive breastfeeding at 2 months. (time frame: 2 months)
Measured: 2 months
Rate of exclusive breastfeeding
Exclusive breastfeeding at 1 month. (time frame: 1 month)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies 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
- 434 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Preventive Services and Health Promotion Research Network
- Responsible party
- Sponsor
- Investigators
- Josep Balaguer, Doctor, Principal investigator, Jordi Gol i Gorina Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186613
- Sponsor's protocol ID
- 4R14/015
- Status last verified
- Dec 2014
- First submitted
- 29 Jun 2014
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone Support From Primary Care to Breastfeeding Mothers: A Randomized and Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT02186613
- Acronym / sponsor ID
- 4R14/015
- Conditions
- Breast Feeding
- Keywords
- Breast Feeding, Telephone, Education, Primary Health Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 434 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Preventive Services and Health Promotion Research Network
- Study start
- Oct 2014
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 10 Jul 2014 (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 investigators will conduct a telephone-based support to breastfeeding women with healthy newborns to improve breastfeeding outcomes.
Detailed description
The World Health Organization recommends exclusive breastfeeding to infants until 6 months of age in order to achieve optimum growth. The proportion of exclusive breastfeeding mothers at 6 months is only 24.7 in Spain. The investigators believe it is important to increase the proportion of breastfeeding mothers in their population. Therefore, the investigators have developed a telephonic support protocol for mothers. The intervention will be performed by pediatric nurses in Primary Care.
The main aim of this study is to evaluate in a randomized controlled trial the effectiveness of telephone-based breastfeeding support in exclusive breastfeeding. The secondary aim is to evaluate the effectiveness of the telephonic support in any breastfeeding.
The investigators hypothesis is that this intervention will increase exclusive breastfeeding and any breastfeeding rates.
The study will be carried out in Cornellà, a semi-urban area near Barcelona. Participants will include breastfeeding women who have full-term healthy infants. Mothers will be recruited upon their first arrival to Primary Care from hospital. Eligible mothers who consent to participate will be randomized into either the intervention group or the control group. The latter will receive standard postpartum care. The former will receive standard postpartum care, plus a weekly telephone call during the first two months and every 2 weeks thereafter between the second and the sixth month. The pediatric nurse responsible for monitoring the standard care of each and every patient will be the one responsible for contacting them via telephone. Therefore, the study is not blinded.
The evolution of exclusive breastfeeding will be compared to artificial or supplemented feeding at 1, 2, 4 and 6 months. The effect of the intervention on breastfeeding supplemented with formula will also be valued. Classification into breastfeeding categories is based on 24-hour dietary recall.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Telephone supportThese mothers and their babies will receive Primary Care standard care (office visits at 1, 2, 4 and 6 months) plus the telephone support |
| No intervention | No intervention | –Standard care (office visits at 1, 2, 4 and 6 months) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mothers with healthy newborns
- 37 weeks gestation or greater
- Exclusive breastfeeding or any breastfeeding when arrive at Primary Care
Key exclusion criteria (7 listed)
- Infant or mother admitted in ICU
- Twin pregnancy
- Major congenital malformation of babies
- Mothers age <= 18
- Inability to understand Spanish/Catalan
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 |
|---|---|---|
| Telephone supportTelephone support intervention to improve breastfeeding rates. The intervention will consist in weekly calls during the first two months and every two weeks between the second and the sixth month. The intervention will be done by pediatric nurses and we have developed a protocol of important issues to deal depending on the age of the baby. | Behavioural | Experimental |
Primary outcome
Rate of exclusive breastfeeding
Time frame: 6 months
Exclusive breastfeeding at 6 months. (time frame: 6 months)
3 secondary outcomes
Rate of exclusive breastfeeding
Time frame: 4 months
Rate of exclusive breastfeeding
Time frame: 2 months
Rate of exclusive breastfeeding
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
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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.
Josep Balaguer, Doctor principal investigator
Jordi Gol i Gorina Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone support in people with Breast Feeding, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina 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 7 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: status not confirmed, as of the sponsor's last update on 23 Dec 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Josep Balaguer Martinez, Doctor (34-93-4712000 ext. 509, jbalaguer@ambitcp.catsalut.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of exclusive breastfeeding (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Dec 2014.