Promotion of Breastfeeding Intervention Trial (PROBIT)

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
European Union EarlyNutrition program
University of Bristol
Information provided by (Responsible Party):
Emily Oken, Harvard Pilgrim Health Care
ClinicalTrials.gov Identifier:
NCT01561612
First received: March 20, 2012
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

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 Intervention
Effect of Breastfeeding on Maternal and Child Health Outcomes
Behavioral: Breastfeeding promotion and support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Breastfeeding Promotion RCT and Child Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Harvard Pilgrim Health Care:

Primary Outcome Measures:
  • Gastrointestinal tract infection [ Time Frame: 12 months of age ] [ Designated as safety issue: No ]
    Occurrence of 1 or more episodes of gastrointestinal tract infection


Secondary Outcome Measures:
  • Maternal adiposity [ Time Frame: 6.5 and 11.5 years postpartum ] [ Designated as safety issue: No ]
  • Child adiposity [ Time Frame: Throughout childhood ] [ Designated as safety issue: No ]
  • asthma [ Time Frame: 6.5 and 16 years ] [ Designated as safety issue: No ]
  • cognition [ Time Frame: 6.5 and 16 years ] [ Designated as safety issue: No ]
  • dental caries [ Time Frame: 6.5 years ] [ Designated as safety issue: No ]
  • child behavior [ Time Frame: 6.5 years ] [ Designated as safety issue: No ]
  • vision [ Time Frame: 16 years ] [ Designated as safety issue: No ]
  • lung function [ Time Frame: 16 years ] [ Designated as safety issue: No ]
  • IGF-1 [ Time Frame: Age 11.5 years ] [ Designated as safety issue: No ]
    IGF from dried bloodspots

  • child height [ Time Frame: throughout childhood ] [ Designated as safety issue: Yes ]
    Research measures of length/height

  • adiponectin [ Time Frame: age 11.5 years ] [ Designated as safety issue: No ]
    adiponectin from dried bloodspot

  • Apo A1 [ Time Frame: Child age 11.5 years ] [ Designated as safety issue: No ]
    Apo A1 in dried bloodspots

  • glucose [ Time Frame: child age 11.5 years ] [ Designated as safety issue: No ]
    fingerstick glucose measured by glucometer

  • insulin [ Time Frame: child age 11.5 years ] [ Designated as safety issue: No ]
    insulin measured on dried blood spots

  • Apo B [ Time Frame: Child age 11.5 years ] [ Designated as safety issue: No ]
    Apo B measured in dried blood spots

  • Child blood pressure [ Time Frame: throughout childhood ] [ Designated as safety issue: No ]
    Research measures of blood pressure at ages 6.5, 11.5 and 16 years

  • Maternal blood pressure [ Time Frame: 11.5 years postpartum ] [ Designated as safety issue: No ]
    Research measure of maternal blood pressure

  • Child metabolic syndrome [ Time Frame: Age 11.5 years ]
  • Child growth [ Time Frame: Throughout childhood ] [ Designated as safety issue: No ]
    Growth in weight, length, weight for length, BMI, and other measures

  • Respiratory tract infections [ Time Frame: to age 12 months and throughout childhood ] [ Designated as safety issue: No ]
    Number of respiratory infections, from review of medical record

  • Atopic Eczema [ Time Frame: Throughout childhood ] [ Designated as safety issue: No ]
    Eczema from review of medical record, parent report,and direct examination

  • Atopy [ Time Frame: Age 6.5 years ] [ Designated as safety issue: No ]
    Skinprick tests for allergy

  • Eating Attitudes [ Time Frame: Age 11.5 years ] [ Designated as safety issue: No ]
    Children's Eating Attitudes Test (ChEAT) Questionnaire


Enrollment: 17046
Study Start Date: June 1996
Primary Completion Date: December 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561612

Locations
Belarus
Maternal and Child Health Center
Minsk, Belarus
Sponsors and Collaborators
Harvard Pilgrim Health Care
Canadian Institutes of Health Research (CIHR)
European Union EarlyNutrition program
University of Bristol
Investigators
Principal Investigator: Emily Oken, MD Harvard Pilgrim Health Care
Principal Investigator: Richard M Martin, MD University of Bristol
  More Information

Additional Information:
Publications:

Additional 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, FOOD-DT-2005-007036, G0600705, K24HD069408, MOP-53155
Study First Received: March 20, 2012
Last Updated: October 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Harvard Pilgrim Health Care:
Breastfeeding
Child Health
Obesity
Blood Pressure
Asthma
Cognitive Development
Behavior
Eczema
Lung Function
Spirometry

ClinicalTrials.gov processed this record on August 28, 2014