Telephone Support From Primary Care to Breastfeeding Mothers: A Randomized and Multicenter Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Feeding
- Sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Enrollment
- 434
- Locations
- 1
- Primary Endpoint
- Rate of exclusive breastfeeding
- Last Updated
- 11 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Rate of exclusive breastfeeding
Time Frame: 6 months
Exclusive breastfeeding at 6 months. (time frame: 6 months)
Secondary Outcomes
- Rate of exclusive breastfeeding(1 month)