Clinical trial NCT03357549: Project to Promotion of Breastfeeding
Official title: Effectiveness of an Brief Motivational Intervention to Promote Breastfeeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Feeding
Keywords: Breast Feeding
Motivational Interviewing
Self Efficacy
Lead sponsor: University of Extremadura
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 88
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Changes in degree of exclusivility of Breastfeeding
timeFrame: 1st, 3st and 6th month postpartum
Secondary outcomes:
measure: Changes in Breastfeeding Self-efficacy
timeFrame: Pre-intervention. 1st, 3rd and 6th month
measure: Changes on General Self-efficacy
timeFrame: Pre-intervention, 1st, 3rd and 6th month
Other outcomes:
Locations:
city: Don Benito
country: Spain
facility: Don Benito- Villanueva's Hospital
state: Badajoz
Study officials:
affiliation: Extremadura University
name: Cristina Franco, Midwife
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.