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Promotion of Breastfeeding Intervention Trial (PROBIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01561612
Recruitment Status : Completed
First Posted : March 23, 2012
Last Update Posted : October 10, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Effect of Breastfeeding on Maternal and Child Health Outcomes Behavioral: Breastfeeding promotion and support

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17046 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Breastfeeding Promotion RCT and Child Metabolic Syndrome
Study Start Date : June 1996
Primary Completion Date : December 1998

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
No Intervention: Control
Usual care

Outcome Measures

Primary Outcome Measures :
  1. Gastrointestinal tract infection [ Time Frame: 12 months of age ]
    Occurrence of 1 or more episodes of gastrointestinal tract infection

Secondary Outcome Measures :
  1. Maternal adiposity [ Time Frame: 6.5 and 11.5 years postpartum ]
  2. Child adiposity [ Time Frame: Throughout childhood ]
  3. asthma [ Time Frame: 6.5 and 16 years ]
  4. cognition [ Time Frame: 6.5 and 16 years ]
  5. dental caries [ Time Frame: 6.5 years ]
  6. child behavior [ Time Frame: 6.5 years ]
  7. vision [ Time Frame: 16 years ]
  8. lung function [ Time Frame: 16 years ]
  9. IGF-1 [ Time Frame: Age 11.5 years ]
    IGF from dried bloodspots

  10. child height [ Time Frame: throughout childhood ]
    Research measures of length/height

  11. adiponectin [ Time Frame: age 11.5 years ]
    adiponectin from dried bloodspot

  12. Apo A1 [ Time Frame: Child age 11.5 years ]
    Apo A1 in dried bloodspots

  13. glucose [ Time Frame: child age 11.5 years ]
    fingerstick glucose measured by glucometer

  14. insulin [ Time Frame: child age 11.5 years ]
    insulin measured on dried blood spots

  15. Apo B [ Time Frame: Child age 11.5 years ]
    Apo B measured in dried blood spots

  16. Child blood pressure [ Time Frame: throughout childhood ]
    Research measures of blood pressure at ages 6.5, 11.5 and 16 years

  17. Maternal blood pressure [ Time Frame: 11.5 years postpartum ]
    Research measure of maternal blood pressure

  18. Child metabolic syndrome [ Time Frame: Age 11.5 years ]
  19. Child growth [ Time Frame: Throughout childhood ]
    Growth in weight, length, weight for length, BMI, and other measures

  20. Respiratory tract infections [ Time Frame: to age 12 months and throughout childhood ]
    Number of respiratory infections, from review of medical record

  21. Atopic Eczema [ Time Frame: Throughout childhood ]
    Eczema from review of medical record, parent report,and direct examination

  22. Atopy [ Time Frame: Age 6.5 years ]
    Skinprick tests for allergy

  23. Eating Attitudes [ Time Frame: Age 11.5 years ]
    Children's Eating Attitudes Test (ChEAT) Questionnaire

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01561612

Maternal and Child Health Center
Minsk, Belarus
Sponsors and Collaborators
Harvard Pilgrim Health Care
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Canadian Institutes of Health Research (CIHR)
European Union EarlyNutrition program
University of Bristol
Principal Investigator: Emily Oken, MD Harvard Pilgrim Health Care
Principal Investigator: Richard M Martin, MD University of Bristol
More Information

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Emily Oken, Associate Professor, Harvard Pilgrim Health Care
ClinicalTrials.gov Identifier: NCT01561612     History of Changes
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 )
First Posted: March 23, 2012    Key Record Dates
Last Update Posted: October 10, 2013
Last Verified: October 2013

Keywords provided by Emily Oken, Harvard Pilgrim Health Care:
Child Health
Blood Pressure
Cognitive Development
Lung Function