Project to Promotion of Breastfeeding (MOTIVA)

• ClinicalTrials.gov Identifier: NCT03357549
• Recruitment Status: Completed
• First Posted: November 30, 2017
• Last Update Posted: June 14, 2019
• Sponsor: University of Extremadura
• Information provided by (Responsible Party): Cristina Franco Antonio, University of Extremadura

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Feeding	Other: Brief Motivational Intervention; Other: Breastfeeding education	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Effectiveness of an Brief Motivational Intervention to Promote Breastfeeding
• Actual Study Start Date: January 11, 2018
• Actual Primary Completion Date: March 31, 2019
• Actual Study Completion Date: March 31, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Spain

Don Benito- Villanueva's Hospital

Don Benito, Badajoz, Spain, 06400

Sponsors and Collaborators

University of Extremadura

Investigators

• Principal Investigator: Cristina Franco, Midwife; Extremadura University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Franco-Antonio C, Calderón-García JF, Santano-Mogena E, Rico-Martín 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.

• Responsible Party: Cristina Franco Antonio, Nurse specialist in obstetrics and gynecology (Midwife), University of Extremadura
• ClinicalTrials.gov Identifier: NCT03357549
• Other Study ID Numbers: Moti003
• First Posted: November 30, 2017
• Last Update Posted: June 14, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cristina Franco Antonio, University of Extremadura:

Breast Feeding; Motivational Interviewing; Self Efficacy