Project to Promotion of Breastfeeding (MOTIVA)

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.

Study Overview

• Status: Completed
• Conditions: Breast Feeding
• Intervention / Treatment: Other: Brief Motivational Intervention; Other: Breastfeeding education

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Badajoz
    • Don Benito, Badajoz, Spain, 06400
      • Don Benito- Villanueva's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brief Motivational Intervention; The women of this group will receive a Brief Motivational Intervention during 20 or 30 minutes.	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.
Active Comparator: Breastfeeding education; The women of this group will receive a standard education about breastfeeding during 20-30 minutes	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Extremadura
• Investigators: Principal Investigator: Cristina Franco, Midwife, Extremadura University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2018
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: October 23, 2017
• First Submitted That Met QC Criteria: November 23, 2017
• First Posted (Actual): November 30, 2017

Study Record Updates

• Last Update Posted (Actual): June 14, 2019
• Last Update Submitted That Met QC Criteria: June 13, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Motivational Interviewing; Breast Feeding; Self Efficacy
• Other Study ID Numbers: Moti003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No