Promotion of Breastfeeding Intervention Trial (PROBIT)

September 20, 2023 updated by: Emily Oken, Harvard Pilgrim Health Care

Breastfeeding Promotion RCT and Child Metabolic Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17046

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Minsk, Belarus
        • Maternal and Child Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Usual care
Experimental: Intervention
Breastfeeding promotion according to World Health Organization's Baby Friendly Hospital Initiative
Behavioral: Breastfeeding promotion and support
Breastfeeding promotion and support according to the World Health Organization's Baby Friendly Hospital Initiative

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrointestinal tract infection
Time Frame: 12 months of age
Occurrence of 1 or more episodes of gastrointestinal tract infection
12 months of age

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard Pilgrim Health Care

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Canadian Institutes of Health Research (CIHR)
University of Bristol
European Union EarlyNutrition program

Investigators

  • Principal Investigator: Emily Oken, MD, Harvard Pilgrim Health Care
  • Principal Investigator: Richard M Martin, MD, University of Bristol

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1996

Primary Completion (Actual)

December 1, 1998

Study Registration Dates

First Submitted

March 20, 2012

First Submitted That Met QC Criteria

March 22, 2012

First Posted (Estimated)

March 23, 2012

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 190250
  • R01HD050758 (U.S. NIH Grant/Contract)
  • FOOD-DT-2005-007036 (Other Identifier: European Union's project on Early Nutrition Programming: Long-term Efficacy and Safety Trials)
  • G0600705 (Other Grant/Funding Number: UK Medical Research Council)
  • K24HD069408 (U.S. NIH Grant/Contract)
  • MOP-53155 (Other Grant/Funding Number: Canadian Institutes of Health Research)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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