Breast FeedingMOTIVANCT03357549
Project to Promotion of Breastfeeding
A study testing Brief Motivational Intervention and Breastfeeding education in people with Breast Feeding, run by University of Extremadura at 1 site in Spain.
Trial summary
Breastfeeding is the ideal feeding for the newborn. The success of the initiation and maintenance of breastfeeding can be influenced by different factors, as breastfeeding self-efficacy. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding
- What is being tested?
- Brief Motivational Intervention and Breastfeeding education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSpain
- Study dates
- 11 Jan 2018to 31 Mar 2019
- 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
- All women with term gestations who have given birth healthy newborns by vaginal delivery at the hospital .who agree to participate in the study by signing informed consent, will be includes in the study
Who cannot join
- Mothers who, by medical indication or own decision, do not initiate breastfeeding in the first hour of the newborn's life.
- Mother of children who require admission to the neonatal unit.
- Women with a previously diagnosed psychiatric disorder.
- Neurological or cognitive impairment that impedes the evaluation and the BMI
- Resident status that prevents correct follow-up of patients (eg. residence outside Spain).
- Women with language or communication barriers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an Brief Motivational Intervention to Promote Breastfeeding
Breastfeeding is the ideal feeding for the newborn. The success of the initiation and maintenance of breastfeeding can be influenced by different factors, as breastfeeding self-efficacy. Brief Motivational Intervention (BMI) is a form of collaborative guidance, person-centered approach aimed at strengthening the motivation to adopting healthy initiatives and can increase the self-efficacy.
The hypothesis is that an BMI to promote breastfeeding, during immediate postpartum plus telephone support at the first and third postpartum months, will significant increase in the adherence and duration of breastfeeding compared with the habitual education action applied at the same time. Also, the BMI will increase the breastfeeding self-efficacy of the particpants, and this breastfeeding self-efficacy will be a mediator of the effect between the IMB and the breastfeeding duration.
The general self-efficacy of the participants will change the size of the effect of BMI.
- Conditions
- Breast Feeding
- Being tested
- Brief Motivational Intervention, Breastfeeding education
- Keywords
- Breast Feeding, Motivational Interviewing, Self Efficacy
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Motivational InterventionOther
The Brief Motivational Intervention is an intervention that use strategies are typical of patient-centered interventions. These strategies will help the interviewer to listen, to elicit important information, and to build rapport with the patient and should be used throughout the intervention. The four strategies are Open-Ended Questions, Affirmations, Reflections and Summaries. The objective of de BMI is to increase the client motivation to adopt healthy initiatives, and to increase their self-efficacy to reach their own objectives.
Breastfeeding educationOther
It's a common educational intervention about breastfeeding. The women will receive the information by a leaflet with information about breastfeeding and community resources and they will receive verbal information during 20-30 minutes to resolve their doubts.
| Study group | Role | What they receive |
|---|---|---|
| Brief Motivational Intervention | Experimental | The women of this group will receive a Brief Motivational Intervention during 20 or 30 minutes. Receives: Other: Brief Motivational Intervention |
| Breastfeeding education | Active comparator | The women of this group will receive a standard education about breastfeeding during 20-30 minutes Receives: Other: Breastfeeding education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in degree of exclusivility of Breastfeeding
Breastfeeding is measure acording to degree of exclusivity, acording to WHO definition: Exclusive breastfeeding, Predominant breastfeeding and Partial breastfeeding
Measured: 1st, 3st and 6th month postpartum
Secondary outcomes (2)
Changes in Breastfeeding Self-efficacy
Measure with Breastfeeding Self-efficacy Scale-Short Form (BSES-SF). This scale has a maximum score of 70 and a minimum of 14. Higher scores are related to greater maternal self-efficacy in breastfeeding. Breast-feeding self-efficacy is a mother's confidence in her ability to breastfeed and is predictive of breastfeeding behaviors
Measured: Pre-intervention. 1st, 3rd and 6th month
Changes on General Self-efficacy
Measure with General Self-efficacy Scale. This 10-item questionnaire assesses the belief of people about their ability to properly handle stressors of the daily life. This scale has a maximum score of 100 and a minimum of 10. Higher scores are related to greater general self-efficacy
Measured: Pre-intervention, 1st, 3rd and 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start11 Jan 2018
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Franco Antonio, University of Extremadura
- Investigators
- Cristina Franco, Midwife, Principal investigator, Extremadura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357549
- Sponsor's protocol ID
- Moti003
- Acronym
- MOTIVA
- Status last verified
- Jun 2019
- First submitted
- 23 Oct 2017
- Last updated
- 14 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Franco-Antonio C, Calderon-Garcia JF, Santano-Mogena E, Rico-Martin S, Cordovilla-Guardia S. Effectiveness of a brief motivational intervention to increase the breastfeeding duration in the first 6 months postpartum: Randomized controlled trial. J Adv Nurs. 2020 Mar;76(3):888-902. doi: 10.1111/jan.14274. Epub 2019 Dec 18.
PubMed 31782535
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Brief Motivational Intervention to Promote Breastfeeding
- ClinicalTrials.gov ID
- NCT03357549
- Acronym / sponsor ID
- MOTIVA / Moti003
- Conditions
- Breast Feeding
- Keywords
- Breast Feeding, Motivational Interviewing, Self Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Study start
- 11 Jan 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 30 Nov 2017 (actual)
- 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.
Breastfeeding is the ideal feeding for the newborn. The success of the initiation and maintenance of breastfeeding can be influenced by different factors, as breastfeeding self-efficacy. Brief Motivational Intervention (BMI) is a form of collaborative guidance, person-centered approach aimed at strengthening the motivation to adopting healthy initiatives and can increase the self-efficacy.
The hypothesis is that an BMI to promote breastfeeding, during immediate postpartum plus telephone support at the first and third postpartum months, will significant increase in the adherence and duration of breastfeeding compared with the habitual education action applied at the same time. Also, the BMI will increase the breastfeeding self-efficacy of the particpants, and this breastfeeding self-efficacy will be a mediator of the effect between the IMB and the breastfeeding duration.
The general self-efficacy of the participants will change the size of the effect of BMI.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Motivational Intervention | Experimental | Other: Brief Motivational InterventionThe women of this group will receive a Brief Motivational Intervention during 20 or 30 minutes. |
| Breastfeeding education | Active comparator | Other: Breastfeeding educationThe women of this group will receive a standard education about breastfeeding during 20-30 minutes |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All women with term gestations who have given birth healthy newborns by vaginal delivery at the hospital .who agree to participate in the study by signing informed consent, will be includes in the study
Key exclusion criteria (6 listed)
- Mothers who, by medical indication or own decision, do not initiate breastfeeding in the first hour of the newborn's life.
- Mother of children who require admission to the neonatal unit.
- Women with a previously diagnosed psychiatric disorder.
- Neurological or cognitive impairment that impedes the evaluation and the BMI
- Resident status that prevents correct follow-up of patients (eg. residence outside Spain).
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 |
|---|---|---|
| Brief Motivational InterventionThe Brief Motivational Intervention is an intervention that use strategies are typical of patient-centered interventions. These strategies will help the interviewer to listen, to elicit important information, and to build rapport with the patient and should be used throughout the intervention. The four strategies are Open-Ended Questions, Affirmations, Reflections and Summaries. The objective of de BMI is to increase the client motivation to adopt healthy initiatives, and to increase their self-efficacy to reach their own objectives. | Other | Brief Motivational Intervention |
| Breastfeeding educationIt's a common educational intervention about breastfeeding. The women will receive the information by a leaflet with information about breastfeeding and community resources and they will receive verbal information during 20-30 minutes to resolve their doubts. | Other | Breastfeeding education |
Primary outcome
Changes in degree of exclusivility of Breastfeeding
Time frame: 1st, 3st and 6th month postpartum
Breastfeeding is measure acording to degree of exclusivity, acording to WHO definition: Exclusive breastfeeding, Predominant breastfeeding and Partial breastfeeding
2 secondary outcomes
Changes in Breastfeeding Self-efficacy
Time frame: Pre-intervention. 1st, 3rd and 6th month
Changes on General Self-efficacy
Time frame: Pre-intervention, 1st, 3rd and 6th month
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 14 Jun 2019.
- Derived from this study: PubMed 31782535Franco-Antonio C, Calderon-Garcia JF, Santano-Mogena E, Rico-Martin S, Cordovilla-Guardia S. Effectiveness of a brief motivational intervention to increase the breastfeeding duration in the first 6 months postpartum: Randomized controlled trial. J Adv Nurs. 2020 Mar;76(3):888-902. doi: 10.1111/jan.14274. Epub 2019 Dec 18.
- Individual participant dataSharing planned: Undecided
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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.
Cristina Franco, Midwife principal investigator
Extremadura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Motivational Intervention and Breastfeeding education in people with Breast Feeding, run by University of Extremadura 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 1 inclusion and 6 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 14 Jun 2019. 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?
Changes in degree of exclusivility of Breastfeeding (time frame: 1st, 3st and 6th month postpartum). 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 NCT03357549, which also lists 1 linked publication.
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 14 Jun 2019.