Project to Promotion of Breastfeeding

Not Applicable

Completed

• Conditions: Breast Feeding
• Interventions: Other: Brief Motivational Intervention; Other: Breastfeeding education

• Registration Number: NCT03357549
• Lead Sponsor: University of Extremadura

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-23
• Study First Submitted QC: 2017-11-23
• Study First Posted: 2017-11-30
• Study Start: 2018-01-11
• Primary Completion: 2019-03-31
• Study Completion: 2019-03-31
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-13
• Last Update Posted: 2019-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brief Motivational Intervention	Brief Motivational Intervention	The women of this group will receive a Brief Motivational Intervention during 20 or 30 minutes.
Breastfeeding education	Breastfeeding education	The women of this group will receive a standard education about breastfeeding during 20-30 minutes

Primary Outcome Measures

Name	Time	Method
Changes in degree of exclusivility of Breastfeeding	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

Secondary Outcome Measures

Name	Time	Method
Changes in Breastfeeding Self-efficacy	Pre-intervention. 1st, 3rd and 6th month	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
Changes on General Self-efficacy	Pre-intervention, 1st, 3rd and 6th month	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

Trial Locations

Locations (1)

Don Benito- Villanueva's Hospital; 🇪🇸 Don Benito, Badajoz, Spain