Telephone Support From Primary Care for Breastfeeding Mothers

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

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

Study Overview

• Status: Unknown
• Conditions: Breast Feeding
• Intervention / Treatment: Behavioral: Telephone support

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 Type: Interventional
• Enrollment (Anticipated): 434
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Josep Balaguer Martinez, Doctor; Phone Number: 509 34-93-4712000; Email: jbalaguer@ambitcp.catsalut.net

Study Locations

• Spain
  • Barcelona, Spain, 08007
    • Recruiting
    • Jordi Gol i Gurina Foundation
    • Contact: Josep Balaguer Marinez, Doctor; Phone Number: 509 34-93-4712000; Email: jbalaguer@ambitcp.catsalut.net
    • Principal Investigator: Josep Balaguer Martinez, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; These mothers and their babies will receive Primary Care standard care (office visits at 1, 2, 4 and 6 months) plus the telephone support	Behavioral: Telephone support; Telephone support intervention to improve breastfeeding rates. The intervention will consist in weekly calls during the first two months and every two weeks between the second and the sixth month. The intervention will be done by pediatric nurses and we have developed a protocol of important issues to deal depending on the age of the baby.
No Intervention: No intervention; Standard care (office visits at 1, 2, 4 and 6 months)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of exclusive breastfeeding	Exclusive breastfeeding at 6 months. (time frame: 6 months)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of exclusive breastfeeding	Exclusive Breastfeeding at 4 months. (time frame: 4 months)	4 months
Rate of exclusive breastfeeding	Exclusive breastfeeding at 2 months. (time frame: 2 months)	2 months
Rate of exclusive breastfeeding	Exclusive breastfeeding at 1 month. (time frame: 1 month)	1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of non exclusive breastfeeding	Breastfeeding (non exclusive) at 6 months. (time frame: 6 months)	6 months
Rate of non exclusive breastfeeding	Breastfeeding (non exclusive) at 4 months. (time frame: 4 months)	4 months
Rate of non exclusive breastfeeding	Breastfeeding (non exclusive) at 2 months. (time frame: 2 months)	2 months
Rate of non exclusive breastfeeding	Breastfeeding (non exclusive) at 1 month. (time frame: 1 month)	1 month

Collaborators and Investigators

• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Collaborators: Preventive Services and Health Promotion Research Network
• Investigators: Principal Investigator: Josep Balaguer, Doctor, Jordi Gol i Gorina Foundation

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): March 1, 2016
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: June 29, 2014
• First Submitted That Met QC Criteria: July 7, 2014
• First Posted (Estimate): July 10, 2014

Study Record Updates

• Last Update Posted (Estimate): December 23, 2014
• Last Update Submitted That Met QC Criteria: December 19, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Primary Health Care; Breast Feeding; Education; Telephone
• Other Study ID Numbers: 4R14/015