Project to Promotion of Breastfeeding

NCT03357549 | Completed

• 1 other identifier: Moti003
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Feeding

Keywords

Breast Feeding; Motivational Interviewing; Self Efficacy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in Breastfeeding Self-efficacy

  Pre-intervention. 1st, 3rd and 6th month

• Changes on General Self-efficacy

  Pre-intervention, 1st, 3rd and 6th month

Study Arms (2)

Brief Motivational Intervention

EXPERIMENTAL

The women of this group will receive a Brief Motivational Intervention during 20 or 30 minutes.

Other: Brief Motivational Intervention

Breastfeeding education

ACTIVE COMPARATOR

The women of this group will receive a standard education about breastfeeding during 20-30 minutes

Other: Breastfeeding education

Interventions

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.

Brief Motivational Intervention

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.

Breastfeeding education

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Extremadura: lead

Study Sites (1)

Don Benito- Villanueva's Hospital

Don Benito, Badajoz, 06400, Spain

Location

Related Publications (1)

• 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.

  PMID: 31782535 DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Cristina Franco, Midwife

  Extremadura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse specialist in obstetrics and gynecology (Midwife)

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: November 30, 2017
• Study Start: January 11, 2018
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: June 14, 2019

Record last verified: 2019-06

Locations

ES (1)