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Completed

NCT Number: NCT01561612

Promotion of Breastfeeding Intervention Trial

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.

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Key information

Conditions

Effect of Breastfeeding on Maternal and Child Health Outcomes Asthma Behavior Body Weight Breast Feeding Bronchial Diseases Dermatitis Eczema Feeding Behavior Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases Signs and Symptoms Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

Up to 3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maternal and Child Health Center

Minsk, Belarus

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breastfeeding promotion and support

Behavioral

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

Primary outcomes

  1. Gastrointestinal tract infection

    Time frame: 12 months of age

    Occurrence of 1 or more episodes of gastrointestinal tract infection

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Harvard Pilgrim Health Care

Other

Collaborators

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

Registry information

Official study title

Breastfeeding Promotion RCT and Child Metabolic Syndrome

Acronym: PROBIT

Important dates

Study start
1996
Primary completion
1998
First posted
Mar 23, 2012
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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