Telephone Support From Primary Care for Breastfeeding Mothers

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status: Unknown

Conditions: Breast Feeding

Treatments: Behavioral: Telephone support

Study type: Interventional

Funder types: Other

Identifiers

NCT02186613

4R14/015

Details and patient eligibility

About

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

Full 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.

Enrollment: 434 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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434 participants in 2 patient groups

Experimental

Experimental group

Description:

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

Treatment:

Behavioral: Telephone support

No intervention

No Intervention group

Description:

Standard care (office visits at 1, 2, 4 and 6 months)