Telephone Support From Primary Care for Breastfeeding Mothers

Not Applicable

• Conditions: Breast Feeding
• Interventions: Behavioral: Telephone support

• Registration Number: NCT02186613
• Lead Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

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.

Study Timeline

• Study First Submitted: 2014-06-29
• Study First Submitted QC: 2014-07-07
• Study First Posted: 2014-07-10
• Study Start: 2014-10
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-19
• Last Update Posted: 2014-12-23
• Primary Completion: 2016-03
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 434

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Telephone support	These mothers and their babies will receive Primary Care standard care (office visits at 1, 2, 4 and 6 months) plus the telephone support

Primary Outcome Measures

Name	Time	Method
Rate of exclusive breastfeeding	6 months	Exclusive breastfeeding at 6 months. (time frame: 6 months)

Secondary Outcome Measures

Name	Time	Method
Rate of exclusive breastfeeding	1 month	Exclusive breastfeeding at 1 month. (time frame: 1 month)

Trial Locations

Locations (1)

Jordi Gol i Gurina Foundation; 🇪🇸 Barcelona, Spain