Clinical trial NCT02186613: Telephone Support From Primary Care for Breastfeeding Mothers
Official title: Telephone Support From Primary Care to Breastfeeding Mothers: A Randomized and Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Feeding
Keywords: Breast Feeding
Telephone
Education
Primary Health Care
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Preventive Services and Health Promotion Research Network
First posted: 2014-07-10
Enrollment: 434
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Rate of exclusive breastfeeding
timeFrame: 6 months
Secondary outcomes:
measure: Rate of exclusive breastfeeding
timeFrame: 4 months
measure: Rate of exclusive breastfeeding
timeFrame: 2 months
measure: Rate of exclusive breastfeeding
timeFrame: 1 month
Other outcomes:
measure: Rate of non exclusive breastfeeding
timeFrame: 6 months
measure: Rate of non exclusive breastfeeding
timeFrame: 4 months
measure: Rate of non exclusive breastfeeding
timeFrame: 2 months
measure: Rate of non exclusive breastfeeding
timeFrame: 1 month
Locations:
city: Barcelona
country: Spain
facility: Jordi Gol i Gurina Foundation
Study officials:
affiliation: Jordi Gol i Gorina Foundation
name: Josep Balaguer, Doctor
role: PRINCIPAL_INVESTIGATOR
References: