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OpenTrials
Completed

NCT Number: NCT03357549

Project to Promotion of 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.

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Key information

Conditions

Breast Feeding Behavior Feeding Behavior

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Don Benito- Villanueva's Hospital

Don Benito, Badajoz, 06400, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief Motivational Intervention

Other

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

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Changes in Breastfeeding Self-efficacy

    Time frame: 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

  2. Changes on General Self-efficacy

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Extremadura

Other

Registry information

Official study title

Effectiveness of an Brief Motivational Intervention to Promote Breastfeeding

Acronym: MOTIVA

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 30, 2017
Registry last updated
Jun 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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