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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
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Emily Oken, Harvard Pilgrim Health Care

Tracking Information
First Submitted Date  ICMJE March 20, 2012
First Posted Date  ICMJE March 23, 2012
Last Update Posted Date October 10, 2013
Study Start Date  ICMJE June 1996
Actual Primary Completion Date December 1998   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2012)
Gastrointestinal tract infection [ Time Frame: 12 months of age ]
Occurrence of 1 or more episodes of gastrointestinal tract infection
Original Primary Outcome Measures  ICMJE
 (submitted: March 22, 2012)
  • Infant Growth [ Time Frame: 12 months of age ]
    Growth to 12 months of age
  • Gastrointestinal tract infection [ Time Frame: 12 months of age ]
    Occurrence of 1 or more episodes of gastrointestinal tract infection
  • Respiratory tract infections [ Time Frame: 12 months ]
    2 or more episodes of respiratory tract infection,
  • atopic eczema [ Time Frame: 12 months ]
    atopic eczema
Change History Complete list of historical versions of study NCT01561612 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2012)
  • Maternal adiposity [ Time Frame: 6.5 and 11.5 years postpartum ]
  • Child adiposity [ Time Frame: Throughout childhood ]
  • asthma [ Time Frame: 6.5 and 16 years ]
  • cognition [ Time Frame: 6.5 and 16 years ]
  • dental caries [ Time Frame: 6.5 years ]
  • child behavior [ Time Frame: 6.5 years ]
  • vision [ Time Frame: 16 years ]
  • lung function [ Time Frame: 16 years ]
  • IGF-1 [ Time Frame: Age 11.5 years ]
    IGF from dried bloodspots
  • child height [ Time Frame: throughout childhood ]
    Research measures of length/height
  • adiponectin [ Time Frame: age 11.5 years ]
    adiponectin from dried bloodspot
  • Apo A1 [ Time Frame: Child age 11.5 years ]
    Apo A1 in dried bloodspots
  • glucose [ Time Frame: child age 11.5 years ]
    fingerstick glucose measured by glucometer
  • insulin [ Time Frame: child age 11.5 years ]
    insulin measured on dried blood spots
  • Apo B [ Time Frame: Child age 11.5 years ]
    Apo B measured in dried blood spots
  • Child blood pressure [ Time Frame: throughout childhood ]
    Research measures of blood pressure at ages 6.5, 11.5 and 16 years
  • Maternal blood pressure [ Time Frame: 11.5 years postpartum ]
    Research measure of maternal blood pressure
  • Child metabolic syndrome [ Time Frame: Age 11.5 years ]
  • Child growth [ Time Frame: Throughout childhood ]
    Growth in weight, length, weight for length, BMI, and other measures
  • Respiratory tract infections [ Time Frame: to age 12 months and throughout childhood ]
    Number of respiratory infections, from review of medical record
  • Atopic Eczema [ Time Frame: Throughout childhood ]
    Eczema from review of medical record, parent report,and direct examination
  • Atopy [ Time Frame: Age 6.5 years ]
    Skinprick tests for allergy
  • Eating Attitudes [ Time Frame: Age 11.5 years ]
    Children's Eating Attitudes Test (ChEAT) Questionnaire
Original Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2012)
  • Maternal adiposity [ Time Frame: 11 years postpartum ]
  • Child adiposity [ Time Frame: 6 and 11.5 years ]
  • asthma [ Time Frame: 6.5 and 16 years ]
  • cognition [ Time Frame: 6.5 and 16 years ]
  • dental caries [ Time Frame: 6.5 years ]
  • child behavior [ Time Frame: 6.5 years ]
  • vision [ Time Frame: 16 years ]
  • lung function [ Time Frame: 16 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Promotion of Breastfeeding Intervention Trial
Official Title  ICMJE Breastfeeding Promotion RCT and Child Metabolic Syndrome
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Effect of Breastfeeding on Maternal and Child Health Outcomes
Intervention  ICMJE Behavioral: Breastfeeding promotion and support
Breastfeeding promotion and support according to the World Health Organization's Baby Friendly Hospital Initiative
Study Arms  ICMJE
  • Experimental: Intervention
    Breastfeeding promotion according to World Health Organization's Baby Friendly Hospital Initiative
    Intervention: Behavioral: Breastfeeding promotion and support
  • No Intervention: Control
    Usual care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 22, 2012)
17046
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 1998   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belarus
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01561612
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Emily Oken, Harvard Pilgrim Health Care
Study Sponsor  ICMJE Harvard Pilgrim Health Care
Collaborators  ICMJE
  • 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
Investigators  ICMJE
Principal Investigator: Emily Oken, MD Harvard Pilgrim Health Care
Principal Investigator: Richard M Martin, MD University of Bristol
PRS Account Harvard Pilgrim Health Care
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP