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Effect of Breastfeeding on Maternal and Child Health OutcomesPROBITNCT01561612

Promotion of Breastfeeding Intervention Trial

A study testing Breastfeeding promotion and support in people with Effect of Breastfeeding on Maternal and Child Health Outcomes, run by Harvard Pilgrim Health Care at 1 site in Belarus.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 3 days
What is being tested?
Breastfeeding promotion and support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17,046 participants
Where
1 siteBelarus
Study dates
Jun 1996to Dec 1998
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 3 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Belarus1 site

  • Maternal and Child Health Center

    Minsk

Other trials in Belarus

About this study

Official title: Breastfeeding Promotion RCT and Child Metabolic Syndrome

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.

Being tested
Breastfeeding promotion and support
Keywords
Breastfeeding, Child Health, Obesity, Blood Pressure, Asthma, Cognitive Development, Behavior, Eczema, Lung Function, Spirometry
Medical subject headings
Breast Feeding, Obesity, Asthma, Behavior, Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Breastfeeding promotion and supportBehavioural

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

Study groups in NCT01561612
Study groupRoleWhat they receive
InterventionExperimentalBreastfeeding promotion according to World Health Organization's Baby Friendly Hospital Initiative
Receives: Behavioral: Breastfeeding promotion and support
ControlNo interventionUsual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gastrointestinal tract infection

    Occurrence of 1 or more episodes of gastrointestinal tract infection

    Measured: 12 months of age

Secondary outcomes (23)

  1. Maternal adiposity

    Measured: 6.5 and 11.5 years postpartum

  2. Child adiposity

    Measured: Throughout childhood

  3. asthma

    Measured: 6.5 and 16 years

  4. cognition

    Measured: 6.5 and 16 years

  5. dental caries

    Measured: 6.5 years

  6. child behavior

    Measured: 6.5 years

  7. vision

    Measured: 16 years

  8. lung function

    Measured: 16 years

  9. IGF-1

    IGF from dried bloodspots

    Measured: Age 11.5 years

  10. child height

    Research measures of length/height

    Measured: throughout childhood

  11. adiponectin

    adiponectin from dried bloodspot

    Measured: age 11.5 years

  12. Apo A1

    Apo A1 in dried bloodspots

    Measured: Child age 11.5 years

  13. glucose

    fingerstick glucose measured by glucometer

    Measured: child age 11.5 years

  14. insulin

    insulin measured on dried blood spots

    Measured: child age 11.5 years

  15. Apo B

    Apo B measured in dried blood spots

    Measured: Child age 11.5 years

  16. Child blood pressure

    Research measures of blood pressure at ages 6.5, 11.5 and 16 years

    Measured: throughout childhood

  17. Maternal blood pressure

    Research measure of maternal blood pressure

    Measured: 11.5 years postpartum

  18. Child metabolic syndrome

    Measured: Age 11.5 years

  19. Child growth

    Growth in weight, length, weight for length, BMI, and other measures

    Measured: Throughout childhood

  20. Respiratory tract infections

    Number of respiratory infections, from review of medical record

    Measured: to age 12 months and throughout childhood

  21. Atopic Eczema

    Eczema from review of medical record, parent report,and direct examination

    Measured: Throughout childhood

  22. Atopy

    Skinprick tests for allergy

    Measured: Age 6.5 years

  23. Eating Attitudes

    Children's Eating Attitudes Test (ChEAT) Questionnaire

    Measured: Age 11.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2012 (estimated)
  2. Study startJun 1996
  3. Primary completionDec 1998

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
17,046 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01561612
Sponsor's protocol ID
190250
Other IDs
R01HD050758, FOOD-DT-2005-007036, G0600705, K24HD069408, MOP-53155
Acronym
PROBIT
Status last verified
Sep 2023
First submitted
20 Mar 2012
Last updated
22 Sep 2023
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 11065083

  • 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.

    PubMed 11242425

  • 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.

    PubMed 12165588

  • 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.

    PubMed 12885711

  • 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.

    PubMed 15144467

  • 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.

    PubMed 15384567

  • 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.

    PubMed 17878730

  • 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.

    PubMed 17855282

  • 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.

    PubMed 18033894

  • 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.

    PubMed 18065591

  • 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.

    PubMed 18310164

  • 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.

    PubMed 19106322

  • 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.

    PubMed 19227539

  • 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.

    PubMed 19302257

  • 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.

    PubMed 19700507

Questions about this trial

What is this clinical trial studying?

A study testing Breastfeeding promotion and support in people with Effect of Breastfeeding on Maternal and Child Health Outcomes, run by Harvard Pilgrim Health Care at 1 site in Belarus.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gastrointestinal tract infection (time frame: 12 months of age). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01561612, which also lists 45 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.

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