Randomized Controlled Trial

. 2014 Jun;43(3):679-90.

doi: 10.1093/ije/dyt003. Epub 2013 Mar 7.

Cohort profile: The promotion of breastfeeding intervention trial (PROBIT)

Affiliations

¹ School of Social and Community Medicine, University of Bristol, Bristol, UK, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, USA, The National Research and Applied Medicine Mother and Child Centre, Minsk, Belarus, Belarussian Ministry of Health, Minsk, Belarus, Department of Obstetrics and Gynaecology and Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada, Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Ontario, Canada, Departments of Pediatrics & Epidemiology, Biostatistics and Occupational Health, McGill University Faculty of Medicine, Montreal, Canada and MRC Centre for Causal Analyses in Translational Epidemiology (CAiTE), School of Social and Community Medicine, University of Bristol, Bristol, UK Rita.Patel@bristol.ac.uk.
² School of Social and Community Medicine, University of Bristol, Bristol, UK, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, USA, The National Research and Applied Medicine Mother and Child Centre, Minsk, Belarus, Belarussian Ministry of Health, Minsk, Belarus, Department of Obstetrics and Gynaecology and Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada, Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Ontario, Canada, Departments of Pediatrics & Epidemiology, Biostatistics and Occupational Health, McGill University Faculty of Medicine, Montreal, Canada and MRC Centre for Causal Analyses in Translational Epidemiology (CAiTE), School of Social and Community Medicine, University of Bristol, Bristol, UK.
³ School of Social and Community Medicine, University of Bristol, Bristol, UK, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, USA, The National Research and Applied Medicine Mother and Child Centre, Minsk, Belarus, Belarussian Ministry of Health, Minsk, Belarus, Department of Obstetrics and Gynaecology and Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada, Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Ontario, Canada, Departments of Pediatrics & Epidemiology, Biostatistics and Occupational Health, McGill University Faculty of Medicine, Montreal, Canada and MRC Centre for Causal Analyses in Translational Epidemiology (CAiTE), School of Social and Community Medicine, University of Bristol, Bristol, UKSchool of Social and Community Medicine, University of Bristol, Bristol, UK, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, USA, The National Research and Applied Medicine Mother and Child Centre, Minsk, Belarus, Belarussian Ministry of Health, Minsk, Belarus, Department of Obstetrics and Gynaecology and Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada, Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Ontario, Canada, Departments of Pediatrics & Epidemiology, Biostatistics and Occupational Health, McGill University Faculty of Medicine, Montreal, Canada and MRC Centre for Causal Analyses in Translational Epidemiology (CAiTE), School of Social and Community Medicine, University of Bristol, Bristol, UK.

PMID: 23471837
PMCID: PMC4052126
DOI: 10.1093/ije/dyt003

Randomized Controlled Trial

Cohort profile: The promotion of breastfeeding intervention trial (PROBIT)

Rita Patel et al. Int J Epidemiol. 2014 Jun.

. 2014 Jun;43(3):679-90.

doi: 10.1093/ije/dyt003. Epub 2013 Mar 7.

Affiliations

¹ School of Social and Community Medicine, University of Bristol, Bristol, UK, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, USA, The National Research and Applied Medicine Mother and Child Centre, Minsk, Belarus, Belarussian Ministry of Health, Minsk, Belarus, Department of Obstetrics and Gynaecology and Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada, Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Ontario, Canada, Departments of Pediatrics & Epidemiology, Biostatistics and Occupational Health, McGill University Faculty of Medicine, Montreal, Canada and MRC Centre for Causal Analyses in Translational Epidemiology (CAiTE), School of Social and Community Medicine, University of Bristol, Bristol, UK Rita.Patel@bristol.ac.uk.
² School of Social and Community Medicine, University of Bristol, Bristol, UK, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, USA, The National Research and Applied Medicine Mother and Child Centre, Minsk, Belarus, Belarussian Ministry of Health, Minsk, Belarus, Department of Obstetrics and Gynaecology and Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada, Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Ontario, Canada, Departments of Pediatrics & Epidemiology, Biostatistics and Occupational Health, McGill University Faculty of Medicine, Montreal, Canada and MRC Centre for Causal Analyses in Translational Epidemiology (CAiTE), School of Social and Community Medicine, University of Bristol, Bristol, UK.
³ School of Social and Community Medicine, University of Bristol, Bristol, UK, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, USA, The National Research and Applied Medicine Mother and Child Centre, Minsk, Belarus, Belarussian Ministry of Health, Minsk, Belarus, Department of Obstetrics and Gynaecology and Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada, Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Ontario, Canada, Departments of Pediatrics & Epidemiology, Biostatistics and Occupational Health, McGill University Faculty of Medicine, Montreal, Canada and MRC Centre for Causal Analyses in Translational Epidemiology (CAiTE), School of Social and Community Medicine, University of Bristol, Bristol, UKSchool of Social and Community Medicine, University of Bristol, Bristol, UK, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, USA, The National Research and Applied Medicine Mother and Child Centre, Minsk, Belarus, Belarussian Ministry of Health, Minsk, Belarus, Department of Obstetrics and Gynaecology and Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada, Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Ontario, Canada, Departments of Pediatrics & Epidemiology, Biostatistics and Occupational Health, McGill University Faculty of Medicine, Montreal, Canada and MRC Centre for Causal Analyses in Translational Epidemiology (CAiTE), School of Social and Community Medicine, University of Bristol, Bristol, UK.

PMID: 23471837
PMCID: PMC4052126
DOI: 10.1093/ije/dyt003

Abstract

The PROmotion of Breastfeeding Intervention Trial (PROBIT) is a multicentre, cluster-randomized controlled trial conducted in the Republic of Belarus, in which the experimental intervention was the promotion of increased breastfeeding duration and exclusivity, modelled on the Baby-friendly hospital initiative. Between June 1996 and December 1997, 17,046 mother-infant pairs were recruited during their postpartum hospital stay from 31 maternity hospitals, of which 16 hospitals and their affiliated polyclinics had been randomly assigned to the arm of PROBIT investigating the promotion of breastfeeding and 15 had been assigned to the control arm, in which breastfeeding practices and policies in effect at the time of randomization was continued. Of the mother-infant pairs originally recruited for the study, 16,492 (96.7%) were followed at regular intervals until the infants were 12 months of age (PROBIT I) for the outcomes of breastfeeding duration and exclusivity; gastrointestinal and respiratory infections; and atopic eczema. Subsequently, 13,889 (81.5%) of the children from these mother-infant pairs were followed-up at age 6.5 years (PROBIT II) for anthropometry, blood pressure (BP), behaviour, dental health, cognitive function, asthma and atopy outcomes, and 13,879 (81.4%) children were followed to the age of 11.5 years (PROBIT III) for anthropometry, body composition, BP, and the measurement of fasted glucose, insulin, adiponectin, insulin-like growth factor-I, and apolipoproteins. The trial registration number for Current Controlled Trials is ISRCTN37687716 and that for ClinicalTrials.gov is NCT01561612. Proposals for collaboration are welcome, and enquires about PROBIT should be made to an executive group of the study steering committee (M.S.K., R.M.M., and E.O.). More information, including information about how to access the trial data, data collection documents, and bibliography, is available at the trial website (http://www.bristol.ac.uk/social-community-medicine/projects/probit/).

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Figures

**Figure 1**
Location of the 31 hospitals and affiliated polyclinics involved in the Promotion of Breastfeeding Intervention Trial within the Republic of Belarus (numbered 1–34). The large black circle indicates the location of the Chernobyl nuclear reactor in the Ukraine

**Figure 2**
Recruitment and follow-up phases of the Promotion of Breastfeeding Intervention Trial with data for infants and children

**Figure 3**
Recruitment and follow-up phases of the Promotion of Breastfeeding Intervention Trial with data for parents

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References

1. Kramer MS, Chalmers B, Hodnett ED, et al. Promotion of Breastfeeding Intervention Trial (PROBIT): a randomized trial in the Republic of Belarus. JAMA. 2001;285:413–20. - PubMed
1. Kramer MS, Chalmers B, Hodnett ED, et al. Promotion of breastfeeding intervention trial (PROBIT): a cluster-randomized trial in the Republic of Belarus. Design, follow-up, and data validation. Adv Exp Med Biol. 2000;478:327–45. - PubMed
1. Kramer MS, Guo T, Platt RW, et al. Breastfeeding and infant growth: biology or bias? Pediatrics. 2002;110:343–47. - PubMed
1. Kramer MS. Does breast feeding help protect against atopic disease? Biology, methodology, and a golden jubilee of controversy. J Pediatr. 1988;112:181–90. - PubMed
1. WHO/UNICEF. Protecting, Promoting and Supporting Breastfeeding: The Special Role of Maternity Services. Geneva: World Health Organization; 1989.

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Cohort profile: The promotion of breastfeeding intervention trial (PROBIT)

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Cohort profile: The promotion of breastfeeding intervention trial (PROBIT)

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