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Promotion of Breastfeeding Intervention Trial

Breastfeeding Promotion RCT and Child Metabolic Syndrome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01561612
Acronym
PROBIT
Enrollment
17046
Registered
2012-03-23
Start date
1996-06-30
Completion date
Unknown
Last updated
2023-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effect of Breastfeeding on Maternal and Child Health Outcomes

Keywords

Breastfeeding, Child Health, Obesity, Blood Pressure, Asthma, Cognitive Development, Behavior, Eczema, Lung Function, Spirometry

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.

Interventions

BEHAVIORALBreastfeeding promotion and support

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

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
European Union EarlyNutrition program
CollaboratorUNKNOWN
University of Bristol
CollaboratorOTHER
Harvard Pilgrim Health Care
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 3 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Gastrointestinal tract infection12 months of ageOccurrence of 1 or more episodes of gastrointestinal tract infection

Secondary

MeasureTime frameDescription
Child adiposityThroughout childhood
asthma6.5 and 16 years
cognition6.5 and 16 years
dental caries6.5 years
child behavior6.5 years
vision16 years
lung function16 years
IGF-1Age 11.5 yearsIGF from dried bloodspots
child heightthroughout childhoodResearch measures of length/height
adiponectinage 11.5 yearsadiponectin from dried bloodspot
Apo A1Child age 11.5 yearsApo A1 in dried bloodspots
Maternal adiposity6.5 and 11.5 years postpartum
insulinchild age 11.5 yearsinsulin measured on dried blood spots
Apo BChild age 11.5 yearsApo B measured in dried blood spots
Child blood pressurethroughout childhoodResearch measures of blood pressure at ages 6.5, 11.5 and 16 years
Maternal blood pressure11.5 years postpartumResearch measure of maternal blood pressure
Child metabolic syndromeAge 11.5 years
Child growthThroughout childhoodGrowth in weight, length, weight for length, BMI, and other measures
Respiratory tract infectionsto age 12 months and throughout childhoodNumber of respiratory infections, from review of medical record
Atopic EczemaThroughout childhoodEczema from review of medical record, parent report,and direct examination
AtopyAge 6.5 yearsSkinprick tests for allergy
Eating AttitudesAge 11.5 yearsChildren's Eating Attitudes Test (ChEAT) Questionnaire
glucosechild age 11.5 yearsfingerstick glucose measured by glucometer

Countries

Belarus

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026