Promotion of Breastfeeding Intervention Trial (PROBIT)

Harvard Pilgrim Health Care

Status: Completed

Conditions: Effect of Breastfeeding on Maternal and Child Health Outcomes

Treatments: Behavioral: Breastfeeding promotion and support

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01561612

G0600705 (Other Grant/Funding Number)

190250

MOP-53155 (Other Grant/Funding Number)

K24HD069408 (U.S. NIH Grant/Contract)

FOOD-DT-2005-007036 (Other Identifier)

R01HD050758 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The overall goal of the PROBIT study is to investigate the influence of a randomized breastfeeding promotion intervention designed to increase the duration and exclusivity of breastfeeding ("the breastfeeding promotion intervention") on the development of maternal and child health outcomes. The hypothesis is that randomization to the intervention will be associated with lower child adiposity, lower risk of asthma and atopy, improved lung function, and improved cognitive outcomes.

Enrollment: 17,046 patients

Sex: All

Ages: Under 3 days old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Birth at one of 34 Maternity Hospitals in Republic of Belarus
• Breastfeeding initiated at birth, with no contraindications to breastfeeding
• Apgar score >=5 at 5 minutes
• Full term gestation
• Birth weight > 2500g

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17,046 participants in 2 patient groups

Intervention

Experimental group

Description:

Breastfeeding promotion according to World Health Organization's Baby Friendly Hospital Initiative

Treatment:

Behavioral: Breastfeeding promotion and support

Control

No Intervention group

Description:

Usual care