Skip to main content
Clinical Trials/NCT02186613
NCT02186613
Unknown
Not Applicable

Telephone Support From Primary Care to Breastfeeding Mothers: A Randomized and Multicenter Clinical Trial

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina1 site in 1 country434 target enrollmentOctober 2014
ConditionsBreast Feeding

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Feeding
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Enrollment
434
Locations
1
Primary Endpoint
Rate of exclusive breastfeeding
Last Updated
11 years ago

Overview

Brief Summary

The investigators will conduct a telephone-based support to breastfeeding women with healthy newborns to improve breastfeeding outcomes.

Detailed Description

The World Health Organization recommends exclusive breastfeeding to infants until 6 months of age in order to achieve optimum growth. The proportion of exclusive breastfeeding mothers at 6 months is only 24.7 in Spain. The investigators believe it is important to increase the proportion of breastfeeding mothers in their population. Therefore, the investigators have developed a telephonic support protocol for mothers. The intervention will be performed by pediatric nurses in Primary Care. The main aim of this study is to evaluate in a randomized controlled trial the effectiveness of telephone-based breastfeeding support in exclusive breastfeeding. The secondary aim is to evaluate the effectiveness of the telephonic support in any breastfeeding. The investigators hypothesis is that this intervention will increase exclusive breastfeeding and any breastfeeding rates. The study will be carried out in Cornellà, a semi-urban area near Barcelona. Participants will include breastfeeding women who have full-term healthy infants. Mothers will be recruited upon their first arrival to Primary Care from hospital. Eligible mothers who consent to participate will be randomized into either the intervention group or the control group. The latter will receive standard postpartum care. The former will receive standard postpartum care, plus a weekly telephone call during the first two months and every 2 weeks thereafter between the second and the sixth month. The pediatric nurse responsible for monitoring the standard care of each and every patient will be the one responsible for contacting them via telephone. Therefore, the study is not blinded. The evolution of exclusive breastfeeding will be compared to artificial or supplemented feeding at 1, 2, 4 and 6 months. The effect of the intervention on breastfeeding supplemented with formula will also be valued. Classification into breastfeeding categories is based on 24-hour dietary recall.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
March 2016
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Mothers with healthy newborns
  • 37 weeks gestation or greater
  • Exclusive breastfeeding or any breastfeeding when arrive at Primary Care

Exclusion Criteria

  • Infant or mother admitted in ICU
  • Twin pregnancy
  • Major congenital malformation of babies
  • Mothers age \<= 18
  • Inability to understand Spanish/Catalan
  • Mothers who don't have a telephone
  • Mothers who don't give her consent

Outcomes

Primary Outcomes

Rate of exclusive breastfeeding

Time Frame: 6 months

Exclusive breastfeeding at 6 months. (time frame: 6 months)

Secondary Outcomes

  • Rate of exclusive breastfeeding(1 month)

Study Sites (1)

Loading locations...

Similar Trials