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Promotion of Breastfeeding In...

Promotion of Breastfeeding Intervention Trial

Last Updated: 2023-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

Total Enrollment

17046 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-06-30

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.

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Detailed Description

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Conditions

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Effect of Breastfeeding on Maternal and Child Health Outcomes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Breastfeeding promotion and support

Intervention Type BEHAVIORAL

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

Control

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Breastfeeding promotion and support

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

Intervention Type BEHAVIORAL

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

Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Emily Oken

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emily Oken, MD

Role: PRINCIPAL_INVESTIGATOR

Harvard Pilgrim Health Care

Richard M Martin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bristol

Locations

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Maternal and Child Health Center

Minsk, , Belarus

Site Status

Countries

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Belarus

References

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Kramer MS, Chalmers B, Hodnett ED, Sevkovskaya Z, Dzikovich I, Shapiro S, Collet JP, Vanilovich I, Mezen I, Ducruet T, Shishko G, Zubovich V, Mknuik D, Gluchanina E, Dombrovsky V, Ustinovitch A, Ko T, Bogdanovich N, Ovchinikova L, Helsing E. 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.

Reference Type BACKGROUND

PMID: 11065083 (View on PubMed)

Kramer MS, Chalmers B, Hodnett ED, Sevkovskaya Z, Dzikovich I, Shapiro S, Collet JP, Vanilovich I, Mezen I, Ducruet T, Shishko G, Zubovich V, Mknuik D, Gluchanina E, Dombrovskiy V, Ustinovitch A, Kot T, Bogdanovich N, Ovchinikova L, Helsing E; PROBIT Study Group (Promotion of Breastfeeding Intervention Trial). Promotion of Breastfeeding Intervention Trial (PROBIT): a randomized trial in the Republic of Belarus. JAMA. 2001 Jan 24-31;285(4):413-20. doi: 10.1001/jama.285.4.413.

Reference Type BACKGROUND

PMID: 11242425 (View on PubMed)

Kramer MS, Guo T, Platt RW, Shapiro S, Collet JP, Chalmers B, Hodnett E, Sevkovskaya Z, Dzikovich I, Vanilovich I; PROBIT Study Group. Breastfeeding and infant growth: biology or bias? Pediatrics. 2002 Aug;110(2 Pt 1):343-7. doi: 10.1542/peds.110.2.343.

Reference Type BACKGROUND

PMID: 12165588 (View on PubMed)

Kramer MS, Guo T, Platt RW, Sevkovskaya Z, Dzikovich I, Collet JP, Shapiro S, Chalmers B, Hodnett E, Vanilovich I, Mezen I, Ducruet T, Shishko G, Bogdanovich N. Infant growth and health outcomes associated with 3 compared with 6 mo of exclusive breastfeeding. Am J Clin Nutr. 2003 Aug;78(2):291-5. doi: 10.1093/ajcn/78.2.291.

Reference Type BACKGROUND

PMID: 12885711 (View on PubMed)

Kramer MS, Guo T, Platt RW, Sevkovskaya Z, Dzikovich I, Collet JP, Shapiro S, Chalmers B, Hodnett E, Vanilovich I, Mezen I, Ducruet T, Shishko G, Bogdanovich N. Does previous infection protect against atopic eczema and recurrent wheeze in infancy? Clin Exp Allergy. 2004 May;34(5):753-6. doi: 10.1111/j.1365-2222.2004.1940.x.

Reference Type BACKGROUND

PMID: 15144467 (View on PubMed)

Kramer MS, Kakuma R. The optimal duration of exclusive breastfeeding: a systematic review. Adv Exp Med Biol. 2004;554:63-77. doi: 10.1007/978-1-4757-4242-8_7.

Reference Type BACKGROUND

PMID: 15384567 (View on PubMed)

Kramer MS, Vanilovich I, Matush L, Bogdanovich N, Zhang X, Shishko G, Muller-Bolla M, Platt RW. The effect of prolonged and exclusive breast-feeding on dental caries in early school-age children. New evidence from a large randomized trial. Caries Res. 2007;41(6):484-8. doi: 10.1159/000108596. Epub 2007 Sep 18.

Reference Type BACKGROUND

PMID: 17878730 (View on PubMed)

Kramer MS, Matush L, Vanilovich I, Platt R, Bogdanovich N, Sevkovskaya Z, Dzikovich I, Shishko G, Mazer B; Promotion of Breastfeeding Intervention Trial (PROBIT) Study Group. Effect of prolonged and exclusive breast feeding on risk of allergy and asthma: cluster randomised trial. BMJ. 2007 Oct 20;335(7624):815. doi: 10.1136/bmj.39304.464016.AE. Epub 2007 Sep 11.

Reference Type BACKGROUND

PMID: 17855282 (View on PubMed)

Kramer MS. Allergy after breast feeding. Testing hypotheses: reply. BMJ. 2007 Nov 24;335(7629):1061-2. doi: 10.1136/bmj.39395.414144.80. No abstract available.

Reference Type BACKGROUND

PMID: 18033894 (View on PubMed)

Kramer MS, Matush L, Vanilovich I, Platt RW, Bogdanovich N, Sevkovskaya Z, Dzikovich I, Shishko G, Collet JP, Martin RM, Davey Smith G, Gillman MW, Chalmers B, Hodnett E, Shapiro S; PROBIT Study Group. Effects of prolonged and exclusive breastfeeding on child height, weight, adiposity, and blood pressure at age 6.5 y: evidence from a large randomized trial. Am J Clin Nutr. 2007 Dec;86(6):1717-21. doi: 10.1093/ajcn/86.5.1717.

Reference Type BACKGROUND

PMID: 18065591 (View on PubMed)

Kramer MS, Fombonne E, Igumnov S, Vanilovich I, Matush L, Mironova E, Bogdanovich N, Tremblay RE, Chalmers B, Zhang X, Platt RW; Promotion of Breastfeeding Intervention Trial (PROBIT) Study Group. Effects of prolonged and exclusive breastfeeding on child behavior and maternal adjustment: evidence from a large, randomized trial. Pediatrics. 2008 Mar;121(3):e435-40. doi: 10.1542/peds.2007-1248.

Reference Type BACKGROUND

PMID: 18310164 (View on PubMed)

Kramer MS, Matush L, Vanilovich I, Platt RW, Bogdanovich N, Sevkovskaya Z, Dzikovich I, Shishko G, Collet JP, Martin RM, Smith GD, Gillman MW, Chalmers B, Hodnett E, Shapiro S. A randomized breast-feeding promotion intervention did not reduce child obesity in Belarus. J Nutr. 2009 Feb;139(2):417S-21S. doi: 10.3945/jn.108.097675. Epub 2008 Dec 23.

Reference Type BACKGROUND

PMID: 19106322 (View on PubMed)

Kramer MS. Methodological challenges in studying long-term effects of breast-feeding. Adv Exp Med Biol. 2009;639:121-33. doi: 10.1007/978-1-4020-8749-3_10. No abstract available.

Reference Type BACKGROUND

PMID: 19227539 (View on PubMed)

Kramer MS, Matush L, Bogdanovich N, Dahhou M, Platt RW, Mazer B. The low prevalence of allergic disease in Eastern Europe: are risk factors consistent with the hygiene hypothesis? Clin Exp Allergy. 2009 May;39(5):708-16. doi: 10.1111/j.1365-2222.2009.03205.x. Epub 2009 Mar 3.

Reference Type BACKGROUND

PMID: 19302257 (View on PubMed)

Kramer MS, Martin RM, Sterne JA, Shapiro S, Dahhou M, Platt RW. The double jeopardy of clustered measurement and cluster randomisation. BMJ. 2009 Aug 21;339:b2900. doi: 10.1136/bmj.b2900.

Reference Type BACKGROUND

PMID: 19700507 (View on PubMed)

Kramer MS, Matush L, Bogdanovich N, Aboud F, Mazer B, Fombonne E, Collet JP, Hodnett E, Mironova E, Igumnov S, Chalmers B, Dahhou M, Platt RW. Health and development outcomes in 6.5-y-old children breastfed exclusively for 3 or 6 mo. Am J Clin Nutr. 2009 Oct;90(4):1070-4. doi: 10.3945/ajcn.2009.28021. Epub 2009 Aug 26.

Reference Type BACKGROUND

PMID: 19710187 (View on PubMed)

Yang S, Platt RW, Kramer MS. Variation in child cognitive ability by week of gestation among healthy term births. Am J Epidemiol. 2010 Feb 15;171(4):399-406. doi: 10.1093/aje/kwp413. Epub 2010 Jan 15.

Reference Type BACKGROUND

PMID: 20080810 (View on PubMed)

Kramer MS. Breastfeeding, complementary (solid) foods, and long-term risk of obesity. Am J Clin Nutr. 2010 Mar;91(3):500-1. doi: 10.3945/ajcn.2010.29199. Epub 2010 Jan 27. No abstract available.

Reference Type BACKGROUND

PMID: 20107200 (View on PubMed)

Kramer MS. Long-term behavioral consequences of infant feeding: the limits of observational studies. J Pediatr. 2010 Apr;156(4):523-4. doi: 10.1016/j.jpeds.2009.12.002. Epub 2010 Feb 10. No abstract available.

Reference Type BACKGROUND

PMID: 20149388 (View on PubMed)

Kramer MS. "Breast is best": The evidence. Early Hum Dev. 2010 Nov;86(11):729-32. doi: 10.1016/j.earlhumdev.2010.08.005. Epub 2010 Sep 16.

Reference Type BACKGROUND

PMID: 20846797 (View on PubMed)

Martin RM, Kramer MS, Dahhou M, Platt RW, Patel R, Bogdanovich N, Matush L, Davey Smith G; Promotion of Breastfeeding Intervention Trial (PROBIT) Study Group. Do gastrointestinal tract infections in infancy increase blood pressure in childhood? A cohort study. J Epidemiol Community Health. 2010 Dec;64(12):1068-73. doi: 10.1136/jech.2009.090894. Epub 2009 Nov 5.

Reference Type BACKGROUND

PMID: 19897470 (View on PubMed)

Patel R, Martin RM, Kramer MS, Oken E, Bogdanovich N, Matush L, Smith GD, Lawlor DA. Familial associations of adiposity: findings from a cross-sectional study of 12,181 parental-offspring trios from Belarus. PLoS One. 2011 Jan 27;6(1):e14607. doi: 10.1371/journal.pone.0014607.

Reference Type BACKGROUND

PMID: 21298034 (View on PubMed)

Patel R, Lawlor DA, Kramer MS, Smith GD, Bogdanovich N, Matush L, Martin RM. Socio-economic position and adiposity among children and their parents in the Republic of Belarus. Eur J Public Health. 2011 Apr;21(2):158-65. doi: 10.1093/eurpub/ckq041. Epub 2010 Apr 23.

Reference Type BACKGROUND

PMID: 20418336 (View on PubMed)

Kramer MS, Moodie EE, Dahhou M, Platt RW. Breastfeeding and infant size: evidence of reverse causality. Am J Epidemiol. 2011 May 1;173(9):978-83. doi: 10.1093/aje/kwq495. Epub 2011 Mar 23.

Reference Type BACKGROUND

PMID: 21430194 (View on PubMed)

Yang S, Fombonne E, Kramer MS. Duration of gestation, size at birth and later childhood behaviour. Paediatr Perinat Epidemiol. 2011 Jul;25(4):377-87. doi: 10.1111/j.1365-3016.2011.01193.x. Epub 2011 Apr 26.

Reference Type BACKGROUND

PMID: 21649680 (View on PubMed)

Patel R, Lawlor DA, Kramer MS, Davey Smith G, Bogdanovich N, Matush L, Martin RM. Socioeconomic inequalities in height, leg length and trunk length among children aged 6.5 years and their parents from the Republic of Belarus: evidence from the Promotion of Breastfeeding Intervention Trial (PROBIT). Ann Hum Biol. 2011 Sep;38(5):592-602. doi: 10.3109/03014460.2011.577752. Epub 2011 May 19.

Reference Type BACKGROUND

PMID: 21591995 (View on PubMed)

Tilling K, Davies N, Windmeijer F, Kramer MS, Bogdanovich N, Matush L, Patel R, Smith GD, Ben-Shlomo Y, Martin RM; Promotion of Breastfeeding Intervention Trial (PROBIT) study group. Is infant weight associated with childhood blood pressure? Analysis of the Promotion of Breastfeeding Intervention Trial (PROBIT) cohort. Int J Epidemiol. 2011 Oct;40(5):1227-37. doi: 10.1093/ije/dyr119. Epub 2011 Sep 3.

Reference Type BACKGROUND

PMID: 22039193 (View on PubMed)

Yang S, Tilling K, Martin R, Davies N, Ben-Shlomo Y, Kramer MS. Pre-natal and post-natal growth trajectories and childhood cognitive ability and mental health. Int J Epidemiol. 2011 Oct;40(5):1215-26. doi: 10.1093/ije/dyr094. Epub 2011 Jul 15.

Reference Type BACKGROUND

PMID: 21764769 (View on PubMed)

Kramer MS, Fombonne E, Matush L, Bogdanovich N, Dahhou M, Platt RW. Long-term behavioural consequences of infant feeding: the limits of observational studies. Paediatr Perinat Epidemiol. 2011 Nov;25(6):500-6. doi: 10.1111/j.1365-3016.2011.01211.x. Epub 2011 Jun 26.

Reference Type BACKGROUND

PMID: 21980939 (View on PubMed)

Tilling K, Davies NM, Nicoli E, Ben-Shlomo Y, Kramer MS, Patel R, Oken E, Martin RM. Associations of growth trajectories in infancy and early childhood with later childhood outcomes. Am J Clin Nutr. 2011 Dec;94(6 Suppl):1808S-1813S. doi: 10.3945/ajcn.110.001644. Epub 2011 Jun 1.

Reference Type BACKGROUND

PMID: 21633072 (View on PubMed)

Kramer MS. Breastfeeding and allergy: the evidence. Ann Nutr Metab. 2011;59 Suppl 1:20-6. doi: 10.1159/000334148. Epub 2011 Dec 21.

Reference Type BACKGROUND

PMID: 22189253 (View on PubMed)

Yang S, Kramer MS. Paternal alcohol consumption, family transition and child development in a former Soviet country. Int J Epidemiol. 2012 Aug;41(4):1086-96. doi: 10.1093/ije/dys071. Epub 2012 May 13.

Reference Type BACKGROUND

PMID: 22586132 (View on PubMed)

Kramer MS, Moodie EE, Platt RW. Infant feeding and growth: can we answer the causal question? Epidemiology. 2012 Nov;23(6):790-4. doi: 10.1097/EDE.0b013e31826cc0e9. No abstract available.

Reference Type BACKGROUND

PMID: 23038108 (View on PubMed)

Martin RM, Patel R, Zinovik A, Kramer MS, Oken E, Vilchuck K, Bogdanovich N, Sergeichick N, Gunnarsson R, Grufman L, Foo Y, Gusina N. Filter paper blood spot enzyme linked immunoassay for insulin and application in the evaluation of determinants of child insulin resistance. PLoS One. 2012;7(10):e46752. doi: 10.1371/journal.pone.0046752. Epub 2012 Oct 8.

Reference Type BACKGROUND

PMID: 23056434 (View on PubMed)

Patel R, Oken E, Bogdanovich N, Matush L, Sevkovskaya Z, Chalmers B, Hodnett ED, Vilchuck K, Kramer MS, Martin RM. Cohort profile: The promotion of breastfeeding intervention trial (PROBIT). Int J Epidemiol. 2014 Jun;43(3):679-90. doi: 10.1093/ije/dyt003. Epub 2013 Mar 7.

Reference Type BACKGROUND

PMID: 23471837 (View on PubMed)

Martin RM, Patel R, Kramer MS, Guthrie L, Vilchuck K, Bogdanovich N, Sergeichick N, Gusina N, Foo Y, Palmer T, Rifas-Shiman SL, Gillman MW, Smith GD, Oken E. Effects of promoting longer-term and exclusive breastfeeding on adiposity and insulin-like growth factor-I at age 11.5 years: a randomized trial. JAMA. 2013 Mar 13;309(10):1005-13. doi: 10.1001/jama.2013.167.

Reference Type BACKGROUND

PMID: 23483175 (View on PubMed)

Anderson EL, Fraser A, Martin RM, Kramer MS, Oken E, Patel R, Tilling K; PROBIT Study. Associations of postnatal growth with asthma and atopy: the PROBIT Study. Pediatr Allergy Immunol. 2013 Mar;24(2):122-30. doi: 10.1111/pai.12049. Epub 2013 Feb 3.

Reference Type BACKGROUND

PMID: 23374010 (View on PubMed)

Owen CG, Oken E, Rudnicka AR, Patel R, Thompson J, Rifas-Shiman SL, Vilchuck K, Bogdanovich N, Hameza M, Kramer MS, Martin RM. The Effect of Longer-Term and Exclusive Breastfeeding Promotion on Visual Outcome in Adolescence. Invest Ophthalmol Vis Sci. 2018 Jun 1;59(7):2670-2678. doi: 10.1167/iovs.17-23211.

Reference Type DERIVED

PMID: 29860453 (View on PubMed)

Yang S, Martin RM, Oken E, Hameza M, Doniger G, Amit S, Patel R, Thompson J, Rifas-Shiman SL, Vilchuck K, Bogdanovich N, Kramer MS. Breastfeeding during infancy and neurocognitive function in adolescence: 16-year follow-up of the PROBIT cluster-randomized trial. PLoS Med. 2018 Apr 20;15(4):e1002554. doi: 10.1371/journal.pmed.1002554. eCollection 2018 Apr.

Reference Type DERIVED

PMID: 29677187 (View on PubMed)

Flohr C, Henderson AJ, Kramer MS, Patel R, Thompson J, Rifas-Shiman SL, Yang S, Vilchuck K, Bogdanovich N, Hameza M, Martin RM, Oken E. Effect of an Intervention to Promote Breastfeeding on Asthma, Lung Function, and Atopic Eczema at Age 16 Years: Follow-up of the PROBIT Randomized Trial. JAMA Pediatr. 2018 Jan 2;172(1):e174064. doi: 10.1001/jamapediatrics.2017.4064. Epub 2018 Jan 2.

Reference Type DERIVED

PMID: 29131887 (View on PubMed)

Martin RM, Kramer MS, Patel R, Rifas-Shiman SL, Thompson J, Yang S, Vilchuck K, Bogdanovich N, Hameza M, Tilling K, Oken E. Effects of Promoting Long-term, Exclusive Breastfeeding on Adolescent Adiposity, Blood Pressure, and Growth Trajectories: A Secondary Analysis of a Randomized Clinical Trial. JAMA Pediatr. 2017 Jul 3;171(7):e170698. doi: 10.1001/jamapediatrics.2017.0698. Epub 2017 Jul 3.

Reference Type DERIVED

PMID: 28459932 (View on PubMed)

Wade KH, Kramer MS, Oken E, Timpson NJ, Skugarevsky O, Patel R, Bogdanovich N, Vilchuck K, Davey Smith G, Thompson J, Martin RM. Prospective associations between problematic eating attitudes in midchildhood and the future onset of adolescent obesity and high blood pressure. Am J Clin Nutr. 2017 Feb;105(2):306-312. doi: 10.3945/ajcn.116.141697. Epub 2016 Dec 14.

Reference Type DERIVED

PMID: 27974308 (View on PubMed)

Patel R, Tilling K, Lawlor DA, Howe LD, Bogdanovich N, Matush L, Nicoli E, Kramer MS, Martin RM. Socioeconomic differences in childhood length/height trajectories in a middle-income country: a cohort study. BMC Public Health. 2014 Sep 8;14:932. doi: 10.1186/1471-2458-14-932.

Reference Type DERIVED

PMID: 25200513 (View on PubMed)

Martin RM, Patel R, Kramer MS, Vilchuck K, Bogdanovich N, Sergeichick N, Gusina N, Foo Y, Palmer T, Thompson J, Gillman MW, Smith GD, Oken E. Effects of promoting longer-term and exclusive breastfeeding on cardiometabolic risk factors at age 11.5 years: a cluster-randomized, controlled trial. Circulation. 2014 Jan 21;129(3):321-9. doi: 10.1161/CIRCULATIONAHA.113.005160. Epub 2013 Dec 3.

Reference Type DERIVED

PMID: 24300437 (View on PubMed)

Oken E, Patel R, Guthrie LB, Vilchuck K, Bogdanovich N, Sergeichick N, Palmer TM, Kramer MS, Martin RM. Effects of an intervention to promote breastfeeding on maternal adiposity and blood pressure at 11.5 y postpartum: results from the Promotion of Breastfeeding Intervention Trial, a cluster-randomized controlled trial. Am J Clin Nutr. 2013 Oct;98(4):1048-56. doi: 10.3945/ajcn.113.065300. Epub 2013 Aug 14.

Reference Type DERIVED

PMID: 23945719 (View on PubMed)