Telephone Support From Primary Care for Breastfeeding Mothers

Breast Feeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02186613
• Other study ID #: 4R14/015
• Status: Recruiting
• Phase: N/A
• First received: June 29, 2014
• Last updated: December 19, 2014
• Start date: October 2014
• Est. completion date: March 2016

Study information

• Verified date: December 2014
• Source: Jordi Gol i Gurina Foundation
• Contact: Josep Balaguer Martinez, Doctor
• Phone: 34-93-4712000
• Email: jbalaguer[@]ambitcp.catsalut.net
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 434
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Feeding

Intervention

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.

Locations

Country	Name	City	State
Spain	Jordi Gol i Gurina Foundation	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Preventive Services and Health Promotion Research Network

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of non exclusive breastfeeding	Breastfeeding (non exclusive) at 6 months. (time frame: 6 months)	6 months	No
Other	Rate of non exclusive breastfeeding	Breastfeeding (non exclusive) at 4 months. (time frame: 4 months)	4 months	No
Other	Rate of non exclusive breastfeeding	Breastfeeding (non exclusive) at 2 months. (time frame: 2 months)	2 months	No
Other	Rate of non exclusive breastfeeding	Breastfeeding (non exclusive) at 1 month. (time frame: 1 month)	1 month	No
Primary	Rate of exclusive breastfeeding	Exclusive breastfeeding at 6 months. (time frame: 6 months)	6 months	No
Secondary	Rate of exclusive breastfeeding	Exclusive Breastfeeding at 4 months. (time frame: 4 months)	4 months	No
Secondary	Rate of exclusive breastfeeding	Exclusive breastfeeding at 2 months. (time frame: 2 months)	2 months	No
Secondary	Rate of exclusive breastfeeding	Exclusive breastfeeding at 1 month. (time frame: 1 month)	1 month	No