Project to Promotion of Breastfeeding

Breast Feeding Clinical Trial

— MOTIVA  

Official title:

Effectiveness of an Brief Motivational Intervention to Promote Breastfeeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03357549
• Other study ID #: Moti003
• Status: Completed
• Phase: N/A
• Start date: January 11, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: June 2019
• Source: University of Extremadura
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Breast Feeding

Intervention

Other:
• Brief Motivational Intervention
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 education
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.

Locations

Country	Name	City	State
Spain	Don Benito- Villanueva's Hospital	Don Benito	Badajoz

Sponsors (1)

Lead Sponsor	Collaborator
University of Extremadura

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1st, 3st and 6th month postpartum
Secondary	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	Pre-intervention. 1st, 3rd and 6th month
Secondary	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	Pre-intervention, 1st, 3rd and 6th month