Promotion of Breastfeeding Intervention Trial

Study Overview
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Brief Summary
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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.

Official Title
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Breastfeeding Promotion RCT and Child Metabolic Syndrome

Conditions
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Effect of Breastfeeding on Maternal and Child Health Outcomes

Intervention / Treatment
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* Behavioral: Breastfeeding promotion and support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 3 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breastfeeding, Child Health, Obesity, Blood Pressure, Asthma, Cognitive Development, Behavior, Eczema, Lung Function, Spirometry