Promotion of Breastfeeding Intervention Trial

Not Applicable

Completed

• Conditions: Effect of Breastfeeding on Maternal and Child Health Outcomes
• Interventions: Behavioral: Breastfeeding promotion and support

• Registration Number: NCT01561612
• Lead Sponsor: Harvard Pilgrim Health Care

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1996-06
• Primary Completion: 1998-12
• Study First Submitted: 2012-03-20
• Study First Submitted QC: 2012-03-22
• Study First Posted: 2012-03-23
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17046

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Breastfeeding promotion and support	Breastfeeding promotion according to World Health Organization's Baby Friendly Hospital Initiative

Primary Outcome Measures

Name	Time	Method
Gastrointestinal tract infection	12 months of age	Occurrence of 1 or more episodes of gastrointestinal tract infection

Secondary Outcome Measures

Name	Time	Method
Maternal adiposity	6.5 and 11.5 years postpartum
Child adiposity	Throughout childhood
dental caries	6.5 years
lung function	16 years
adiponectin	age 11.5 years	adiponectin from dried bloodspot
Apo A1	Child age 11.5 years	Apo A1 in dried bloodspots
cognition	6.5 and 16 years
child height	throughout childhood	Research measures of length/height
insulin	child age 11.5 years	insulin measured on dried blood spots
Apo B	Child age 11.5 years	Apo B measured in dried blood spots
child behavior	6.5 years
IGF-1	Age 11.5 years	IGF from dried bloodspots
glucose	child age 11.5 years	fingerstick glucose measured by glucometer
Child blood pressure	throughout childhood	Research measures of blood pressure at ages 6.5, 11.5 and 16 years
Child metabolic syndrome	Age 11.5 years
Maternal blood pressure	11.5 years postpartum	Research measure of maternal blood pressure
Child growth	Throughout childhood	Growth in weight, length, weight for length, BMI, and other measures
Respiratory tract infections	to age 12 months and throughout childhood	Number of respiratory infections, from review of medical record
Atopy	Age 6.5 years	Skinprick tests for allergy
Eating Attitudes	Age 11.5 years	Children's Eating Attitudes Test (ChEAT) Questionnaire
Atopic Eczema	Throughout childhood	Eczema from review of medical record, parent report,and direct examination
asthma	6.5 and 16 years
vision	16 years

Trial Locations

Locations (1)

Maternal and Child Health Center; 🇧🇾 Minsk, Belarus