An interventional study of Brief Motivational Intervention and Breastfeeding education in Breast Feeding, sponsored by University of Extremadura. Completed at 1 site in Spain. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-14.
Sponsored by University of Extremadura · Not applicable, Interventional, and Supportive care
Among 35 studies in Breast Feeding with a site in Spain — 6 open to participants now, 9 under way, none of them phase 3. Breast Feeding · Spain.
Among the 35 studies in Breast Feeding with a site in Spain, this one is the 19th largest by enrollment of the 25 interventional ones that give a count, is one of 2 that started in 2018, is one of 20 with no phase, and was the 13th registered.
1,082 studies on the registry are indexed under Breast Feeding; 218 are open to participants now.
Browse Breast Feeding studies →6 of the 35 studies in Breast Feeding with a site in Spain are open now. Recruiting first, the newest first:
Institut Investigacio Sanitaria Pere Virgili · Sites in Spain
Ages 18+ · Women only
Fundació Sant Joan de Déu · Sites in Spain
Ages 18–42 · Women only
Fundación Pública Galega de Investigación Biomédica INIBIC · Sites in Spain
Ages 18+ · Women only
Maimónides Biomedical Research Institute of Córdoba · Sites in Spain
Ages 0 days–120 days · Healthy volunteers
Instituto de Salud Carlos III · Sites in Spain
Healthy volunteers
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 128 Breast Feeding studies recruiting now, 67 (52%) set no upper age limit and 59 (46%) stop at 75 or younger; 54 take children under 18; 76 take healthy volunteers.
This study: female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
35 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 2 · Phase 3 2 · Phase 4 2
First in 2002; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 88 is below the median of 100 across 845 interventional studies indexed under Breast Feeding.
Median enrollment 200 across the 25 interventional studies, 150 across the 10 observational. Of the 21 that completed or were terminated, 1 (5%) have results posted.
This tab as a report to print or save as PDF → With an account.
6 of 35 have an industry lead sponsor. The 10 most frequent:
University of Extremadura is the lead sponsor of 48 studies on the registry; 7 are open to participants now.
University of Extremadura has 1 study filed under Breast Feeding — fewer than ten, so there is no comparison to draw.
3 of the studies in Breast Feeding with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07508917Fundació Sant Joan de DéuEffects of 5-Methyltetrahydrofolic Acid Supplementation on Maternal Health and One-Carbon Metabolism During Lactation | 2026-12-31 |
| NCT07635771Institut Investigacio Sanitaria Pere VirgiliDevelopment of a Multidimensional Predictive Model of Dystocic Labor. Association of Physical Condition and Psychosocial Factors With the Birth Process and Breastfeeding Success. | 2027-06 |
| NCT07309510Fundación Pública Galega de Investigación Biomédica INIBICEffectiveness of a Counseling Program on Exclusive Breastfeeding Rates in a Primary Care Center | 2027-08 |
Add all 3 to your calendar (.ics) → With an account.
Among the 35 studies in Breast Feeding with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The women of this group will receive a Brief Motivational Intervention during 20 or 30 minutes.
Other: Brief Motivational Intervention
The women of this group will receive a standard education about breastfeeding during 20-30 minutes
Other: Breastfeeding education
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.
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.
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
Time frame: 1st, 3st and 6th month postpartum
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
Time frame: 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
Time frame: Pre-intervention, 1st, 3rd and 6th month
Plan to share: Undecided
Ran from Jan 2018 to primary completion in Mar 2019, 14 months.
Of 503 non-industry interventional studies with no phase under Breast Feeding, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 14 months is above that.
Counting every sponsor, half of 511 studies reached it within 12 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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University of Extremadura