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| Name | Class |
|---|---|
| Preventive Services and Health Promotion Research Network | OTHER |
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The investigators will conduct a telephone-based support to breastfeeding women with healthy newborns to improve breastfeeding outcomes.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| No intervention | No Intervention | Standard care (office visits at 1, 2, 4 and 6 months) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephone support | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of exclusive breastfeeding | Exclusive breastfeeding at 6 months. (time frame: 6 months) | 6 months |
| 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) |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Josep Balaguer Martinez, Doctor | Contact | 34-93-4712000 | 509 | jbalaguer@ambitcp.catsalut.net |
| Name | Affiliation | Role |
|---|---|---|
| Josep Balaguer, Doctor | Jordi Gol i Gorina Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jordi Gol i Gurina Foundation | Recruiting | Barcelona | Barcelona | 08007 | Spain |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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|
| 2 months |
| Rate of exclusive breastfeeding | Exclusive breastfeeding at 1 month. (time frame: 1 month) | 1 month |
| 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 |