Project to Promotion of Breastfeeding

NCT ID: NCT03357549

Last Updated: 2019-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-11
• Study Completion Date: 2019-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Brief Motivational Intervention

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

Group Type: EXPERIMENTAL

Brief Motivational Intervention

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Breastfeeding education

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Extremadura

OTHER

Sponsor Role: lead

Responsible Party

Cristina Franco Antonio

Nurse specialist in obstetrics and gynecology (Midwife)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cristina Franco, Midwife

Role: PRINCIPAL_INVESTIGATOR

Extremadura University

Locations

Don Benito- Villanueva's Hospital

Don Benito, Badajoz, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 31782535 (View on PubMed)

Other Identifiers

Moti003

Identifier Type: -

Identifier Source: org_study_id