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PROMISE EBF: Safety and Efficacy of Exclusive Breastfeeding Promotion in the Era of HIV in Sub-Saharan Africa

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00397150
First Posted: November 8, 2006
Last Update Posted: February 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
European Union
The Norwegian Programme for Development, Research and Higher Education
University of Bergen
Université Montpellier
Uppsala University
Centre Muraz
Makerere University
University of Zambia
University of the Western Cape
Information provided by (Responsible Party):
Thorkild Tylleskar, Centre For International Health
  Purpose

The objective of the project is to develop and test an intervention to promote exclusive breastfeeding (EBF), to assess its impact on infant health in African contexts where a high prevalence of HIV is a barrier, and to strengthen the evidence base regarding the optimal duration for EBF.

Promotion of EBF is the most effective child health intervention currently feasible for implementation at the population level in low-income countries. It can lower infant mortality by 13%, and by an additional 2% were it not for the fact that breastfeeding transmits HIV. Only recently proven to be possible in hot and even dry climates, EBF without even offering water is still little appreciated by mothers or supported by health workers. EBF rates are especially low in Africa but the potential for rapid implementation may be high. A few studies elsewhere suggest that peer counselling can often achieve dramatic increases. Thus the investigators will run the first randomised trial to develop and test models for applying this approach in four African countries and to quantify health benefits, cost-effectiveness, and implications for the health care system.

While experts realize that the HIV threat ought not to present much of a biological constraint to promoting EBF, in heavily affected countries it does represent a cultural constraint. Overcoming this will require the development of a safe and effective means of promoting EBF that is HIV-sensitive by taking into account the need to minimise postnatal HIV transmission.

Another scientific constraint to the promotion of exclusive breastfeeding for six months, as recommended by the World Health Organization (WHO), is uncertainty about its impact on the micronutrient status of infants. In a substudy, the investigators will carefully follow markers of infant micronutrient status to see how they vary by feeding pattern, including EBF, for a longer period than has been examined previously.


Condition Intervention
Diarrhea Behavioral: Peer-support for exclusive breastfeeding

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PROMISE EBF: Promoting Infant Health and Nutrition in Sub-Saharan Africa: Safety and Efficacy of Exclusive Breastfeeding Promotion in the Era of HIV

Resource links provided by NLM:


Further study details as provided by Thorkild Tylleskar, Centre For International Health:

Primary Outcome Measures:
  • Exclusive Breastfeeding Rates in Burkina Faso [ Time Frame: at 3 months of age ]
    The EBF prevalences (24-h recall) at 12 weeks in the intervention and control clusters.

  • Infant Morbidity, 2 Week Diarrhoea Prevalence [ Time Frame: at 3 months of age ]
  • Exclusive Breastfeeding Rates in Uganda [ Time Frame: at 3 months of age ]
    The EBF prevalences (24-h recall) at 12 weeks in the intervention and control clusters.

  • Exclusive Breastfeeding Rates in South Africa [ Time Frame: at 3 months of age ]
    The EBF prevalences based on 24-h recall at 12 weeks in the intervention and control clusters.


Secondary Outcome Measures:
  • Growth [ Time Frame: (up to 6 months of age) ]
  • Per Protocol Analysis of EBF Rates [ Time Frame: at 3 months of age ]
  • Per Protocol Analysis of Infant Morbidity [ Time Frame: at 3 months of age ]

Enrollment: 2579
Study Start Date: November 2006
Study Completion Date: April 2011
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Peer-support for exclusive breastfeeding
Behavioral: Peer-support for exclusive breastfeeding
Counselling to support exclusive breastfeeding up to the age of 6 months of age by the use of peer-counsellors in the local community
No Intervention: No intervention
No intervention

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Lives in a selected cluster
  • Is >= 6 months pregnant
  • Has no plans to move outside of the cluster within 1 year

Exclusion Criteria:

  • Reduced ability to collaborate for psychological/mental reasons
  • Severely ill
  • Has given birth more than 7 days ago
  • Has given birth less than 7 days ago and it was a multiple birth; or the child has a severe malformation; or death of the mother or the baby.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00397150


Locations
Burkina Faso
Centre Muraz
Bobo-Dioulasso, Burkina Faso
South Africa
School of Public Health, University of the Western Cape (UWC)
Cape Town, South Africa
Uganda
Dept of Paediatrics and Child Health, Makerere University
Kampala, Uganda
Zambia
Dept of Paediatrics and Child Health, University of Zambia, School of Medicine (UNZA/SOM)
Lusaka, Zambia
Sponsors and Collaborators
Centre For International Health
European Union
The Norwegian Programme for Development, Research and Higher Education
University of Bergen
Université Montpellier
Uppsala University
Centre Muraz
Makerere University
University of Zambia
University of the Western Cape
Investigators
Principal Investigator: Thorkild Tylleskar, MD, PHD Centre For International Health
  More Information

Additional Information:
Publications:
Diallo AH, Meda N, Zabsonré E, Sommerfelt H, Cousens S, Tylleskär T; PROMISE-EBF Study Group. Perinatal mortality in rural Burkina Faso: a prospective community-based cohort study. BMC Pregnancy Childbirth. 2010 Aug 17;10:45. doi: 10.1186/1471-2393-10-45.
Diallo AH, Meda N, Ouédraogo WT, Cousens S, Tylleskar T; PROMISE-EBF Study Group. A prospective study on neonatal mortality and its predictors in a rural area in Burkina Faso: can MDG-4 be met by 2015? J Perinatol. 2011 Oct;31(10):656-63. doi: 10.1038/jp.2011.6. Epub 2011 Mar 3.
Tylleskär T, Jackson D, Meda N, Engebretsen IM, Chopra M, Diallo AH, Doherty T, Ekström EC, Fadnes LT, Goga A, Kankasa C, Klungsøyr JI, Lombard C, Nankabirwa V, Nankunda JK, Van de Perre P, Sanders D, Shanmugam R, Sommerfelt H, Wamani H, Tumwine JK; PROMISE-EBF Study Group. Exclusive breastfeeding promotion by peer counsellors in sub-Saharan Africa (PROMISE-EBF): a cluster-randomised trial. Lancet. 2011 Jul 30;378(9789):420-7. doi: 10.1016/S0140-6736(11)60738-1.
Nankabirwa V, Tylleskar T, Nankunda J, Engebretsen IM, Sommerfelt H, Tumwine JK; PROMISE EBF Research Consortium. Malaria parasitaemia among infants and its association with breastfeeding peer counselling and vitamin A supplementation: a secondary analysis of a cluster randomized trial. PLoS One. 2011;6(7):e21862. doi: 10.1371/journal.pone.0021862. Epub 2011 Jul 7.
Nankabirwa V, Tumwine JK, Tylleskär T, Nankunda J, Sommerfelt H; PROMISE EBF Research Consortium. Perinatal mortality in eastern Uganda: a community based prospective cohort study. PLoS One. 2011 May 9;6(5):e19674. doi: 10.1371/journal.pone.0019674.
Chola L, Fadnes LT, Engebretsen IM, Tumwine JK, Tylleskar T, Robberstad B; PROMISE EBF Study Group. Infant feeding survival and Markov transition probabilities among children under age 6 months in Uganda. Am J Epidemiol. 2013 Mar 1;177(5):453-62. doi: 10.1093/aje/kws254. Epub 2013 Feb 5.
Nkonki LL, Daviaud E, Jackson D, Chola L, Doherty T, Chopra M, Robberstad B; Promise-EBF Study Group. Costs of promoting exclusive breastfeeding at community level in three sites in South Africa. PLoS One. 2014 Jan 10;9(1):e79784. doi: 10.1371/journal.pone.0079784. eCollection 2014.
Engebretsen IM, Jackson D, Fadnes LT, Nankabirwa V, Diallo AH, Doherty T, Lombard C, Swanvelder S, Nankunda J, Ramokolo V, Sanders D, Wamani H, Meda N, Tumwine JK, Ekström EC, Van de Perre P, Kankasa C, Sommerfelt H, Tylleskär T; PROMISE EBF-study group. Growth effects of exclusive breastfeeding promotion by peer counsellors in sub-Saharan Africa: the cluster-randomised PROMISE EBF trial. BMC Public Health. 2014 Jun 21;14:633. doi: 10.1186/1471-2458-14-633.
Doherty T, Jackson D, Swanevelder S, Lombard C, Engebretsen IM, Tylleskär T, Goga A, Ekström EC, Sanders D; PROMISE EBF study group. Severe events in the first 6 months of life in a cohort of HIV-unexposed infants from South Africa: effects of low birthweight and breastfeeding status. Trop Med Int Health. 2014 Oct;19(10):1162-9. doi: 10.1111/tmi.12355. Epub 2014 Jul 23.
Fadnes LT, Nankabirwa V, Sommerfelt H, Tylleskär T, Tumwine JK, Engebretsen IM; PROMISE-EBF Study Group. Is vaccination coverage a good indicator of age-appropriate vaccination? A prospective study from Uganda. Vaccine. 2011 Apr 27;29(19):3564-70. doi: 10.1016/j.vaccine.2011.02.093. Epub 2011 Mar 12.
Nankabirwa V, Tylleskär T, Tumwine JK, Sommerfelt H; Promise-ebf Study Group. Maternal education is associated with vaccination status of infants less than 6 months in Eastern Uganda: a cohort study. BMC Pediatr. 2010 Dec 15;10:92. doi: 10.1186/1471-2431-10-92.
Nkonki LL, Daniels KL; PROMISE-EBF study group. Selling a service: experiences of peer supporters while promoting exclusive infant feeding in three sites in South Africa. Int Breastfeed J. 2010 Oct 26;5:17. doi: 10.1186/1746-4358-5-17.
Nankunda J, Tumwine JK, Nankabirwa V, Tylleskär T; PROMISE-EBF Study Group. "She would sit with me": mothers' experiences of individual peer support for exclusive breastfeeding in Uganda. Int Breastfeed J. 2010 Oct 26;5:16. doi: 10.1186/1746-4358-5-16.
Engebretsen IM, Moland KM, Nankunda J, Karamagi CA, Tylleskär T, Tumwine JK. Gendered perceptions on infant feeding in Eastern Uganda: continued need for exclusive breastfeeding support. Int Breastfeed J. 2010 Oct 26;5:13. doi: 10.1186/1746-4358-5-13.
Engebretsen IM, Shanmugam R, Sommerfelt AE, Tumwine JK, Tylleskär T. Infant feeding modalities addressed in two different ways in Eastern Uganda. Int Breastfeed J. 2010 Feb 4;5(1):2. doi: 10.1186/1746-4358-5-2.
Wandera MN, Engebretsen IM, Rwenyonyi CM, Tumwine J, Astrøm AN; PROMISE-EBF Study Group. Periodontal status, tooth loss and self-reported periodontal problems effects on oral impacts on daily performances, OIDP, in pregnant women in Uganda: a cross-sectional study. Health Qual Life Outcomes. 2009 Oct 14;7:89. doi: 10.1186/1477-7525-7-89.
Nor B, Zembe Y, Daniels K, Doherty T, Jackson D, Ahlberg BM, Ekström EC; PROMISE-EBF Study Group. "Peer but not peer": considering the context of infant feeding peer counseling in a high HIV prevalence area. J Hum Lact. 2009 Nov;25(4):427-34. doi: 10.1177/0890334409341050. Epub 2009 Jul 21.
Wandera M, Engebretsen IM, Okullo I, Tumwine JK, Astrøm AN; PROMISE-EBF Study Group. Socio-demographic factors related to periodontal status and tooth loss of pregnant women in Mbale district, Uganda. BMC Oral Health. 2009 Jul 18;9:18. doi: 10.1186/1472-6831-9-18.
Fjeld E, Siziya S, Katepa-Bwalya M, Kankasa C, Moland KM, Tylleskär T; PROMISE-EBF Study Group. 'No sister, the breast alone is not enough for my baby' a qualitative assessment of potentials and barriers in the promotion of exclusive breastfeeding in southern Zambia. Int Breastfeed J. 2008 Nov 5;3:26. doi: 10.1186/1746-4358-3-26.
Daniels K, Nor B, Jackson D, Ekström EC, Doherty T. Supervision of community peer counsellors for infant feeding in South Africa: an exploratory qualitative study. Hum Resour Health. 2010 Mar 30;8:6. doi: 10.1186/1478-4491-8-6.
Fadnes LT, Engebretsen IM, Moland KM, Nankunda J, Tumwine JK, Tylleskär T. Infant feeding counselling in Uganda in a changing environment with focus on the general population and HIV-positive mothers - a mixed method approach. BMC Health Serv Res. 2010 Sep 6;10:260. doi: 10.1186/1472-6963-10-260.
Engebretsen IM, Wamani H, Karamagi C, Semiyaga N, Tumwine J, Tylleskär T. Low adherence to exclusive breastfeeding in Eastern Uganda: a community-based cross-sectional study comparing dietary recall since birth with 24-hour recall. BMC Pediatr. 2007 Mar 1;7:10.
Engebretsen IM, Tylleskär T, Wamani H, Karamagi C, Tumwine JK. Determinants of infant growth in Eastern Uganda: a community-based cross-sectional study. BMC Public Health. 2008 Dec 22;8:418. doi: 10.1186/1471-2458-8-418.
Fadnes LT, Engebretsen IM, Wamani H, Wangisi J, Tumwine JK, Tylleskär T. Need to optimise infant feeding counselling: a cross-sectional survey among HIV-positive mothers in Eastern Uganda. BMC Pediatr. 2009 Jan 9;9:2. doi: 10.1186/1471-2431-9-2.
Fadnes LT, Engebretsen IM, Wamani H, Semiyaga NB, Tylleskär T, Tumwine JK. Infant feeding among HIV-positive mothers and the general population mothers: comparison of two cross-sectional surveys in Eastern Uganda. BMC Public Health. 2009 May 7;9:124. doi: 10.1186/1471-2458-9-124.
Nankunda J, Tylleskär T, Ndeezi G, Semiyaga N, Tumwine JK; PROMISE-EBF Study Group. Establishing individual peer counselling for exclusive breastfeeding in Uganda: implications for scaling-up. Matern Child Nutr. 2010 Jan;6(1):53-66. doi: 10.1111/j.1740-8709.2009.00187.x.
Nankunda J, Tumwine JK, Soltvedt A, Semiyaga N, Ndeezi G, Tylleskär T. Community based peer counsellors for support of exclusive breastfeeding: experiences from rural Uganda. Int Breastfeed J. 2006 Oct 20;1:19.
Fadnes LT, Jackson D, Engebretsen IM, Zembe W, Sanders D, Sommerfelt H, Tylleskär T; PROMISE-EBF Study Group. Vaccination coverage and timeliness in three South African areas: a prospective study. BMC Public Health. 2011 May 27;11:404. doi: 10.1186/1471-2458-11-404.
Ramokolo V, Lombard C, Fadnes LT, Doherty T, Jackson DJ, Goga AE, Chhagan M, Van den Broeck J. HIV infection, viral load, low birth weight, and nevirapine are independent influences on growth velocity in HIV-exposed South African infants. J Nutr. 2014 Jan;144(1):42-8. doi: 10.3945/jn.113.178616. Epub 2013 Nov 6.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Eide KT, Fadnes LT, Engebretsen IM, Onarheim KH, Wamani H, Tumwine JK, Norheim OF; PROMISE-EBF Study Group**. Impact of a peer-counseling intervention on breastfeeding practices in different socioeconomic strata: results from the equity analysis of the PROMISE-EBF trial in Uganda. Glob Health Action. 2016 Jan;9(1):30578. doi: 10.3402/gha.v9.30578.
Eide KT, Fadnes LT, Engebretsen IM, Onarheim KH, Wamani H, Tumwine JK, Norheim OF; PROMISE-EBF Study Group. Impact of a peer-counseling intervention on breastfeeding practices in different socioeconomic strata: results from the equity analysis of the PROMISE-EBF trial in Uganda. Glob Health Action. 2016 Jul 28;9:30578. doi: 10.3402/gha.v9.30578. eCollection 2016.
Fadnes LT, Nankabirwa V, Engebretsen IM, Sommerfelt H, Birungi N, Lombard C, Swanevelder S, Van den Broeck J, Tylleskär T, Tumwine JK; PROMISE-EBF Study Group. Effects of an exclusive breastfeeding intervention for six months on growth patterns of 4-5 year old children in Uganda: the cluster-randomised PROMISE EBF trial. BMC Public Health. 2016 Jul 12;16:555. doi: 10.1186/s12889-016-3234-3.
Birungi N, Fadnes LT, Okullo I, Kasangaki A, Nankabirwa V, Ndeezi G, Tumwine JK, Tylleskär T, Lie SA, Åstrøm AN. Effect of Breastfeeding Promotion on Early Childhood Caries and Breastfeeding Duration among 5 Year Old Children in Eastern Uganda: A Cluster Randomized Trial. PLoS One. 2015 May 4;10(5):e0125352. doi: 10.1371/journal.pone.0125352. eCollection 2015.
Engebretsen IM, Nankabirwa V, Doherty T, Diallo AH, Nankunda J, Fadnes LT, Ekström EC, Ramokolo V, Meda N, Sommerfelt H, Jackson D, Tylleskär T, Tumwine JK; PROMISE-EBF study group. Early infant feeding practices in three African countries: the PROMISE-EBF trial promoting exclusive breastfeeding by peer counsellors. Int Breastfeed J. 2014 Nov 18;9:19. doi: 10.1186/1746-4358-9-19. eCollection 2014.
Zembe-Mkabile W, Doherty T, Sanders D, Jackson D, Chopra M, Swanevelder S, Lombard C, Surender R. Why do families still not receive the child support grant in South Africa? A longitudinal analysis of a cohort of families across South Africa. BMC Int Health Hum Rights. 2012 Oct 22;12:24. doi: 10.1186/1472-698X-12-24.
Hama Diallo A, Meda N, Sommerfelt H, Traore GS, Cousens S, Tylleskar T; PROMISE-EBF Study Group. The high burden of infant deaths in rural Burkina Faso: a prospective community-based cohort study. BMC Public Health. 2012 Sep 5;12:739. doi: 10.1186/1471-2458-12-739.
Doherty T, Sanders D, Jackson D, Swanevelder S, Lombard C, Zembe W, Chopra M, Goga A, Colvin M, Fadnes LT, Engebretsen IM, Ekström EC, Tylleskär T; PROMISE EBF study group. Early cessation of breastfeeding amongst women in South Africa: an area needing urgent attention to improve child health. BMC Pediatr. 2012 Jul 24;12:105.

Responsible Party: Thorkild Tylleskar, Professor, Centre For International Health
ClinicalTrials.gov Identifier: NCT00397150     History of Changes
Other Study ID Numbers: INCO-CT-2004-003660
First Submitted: November 7, 2006
First Posted: November 8, 2006
Results First Submitted: December 18, 2012
Results First Posted: February 24, 2015
Last Update Posted: February 24, 2015
Last Verified: February 2015

Keywords provided by Thorkild Tylleskar, Centre For International Health:
Infant Nutrition [G06.696.259.750]
Infant Care [N02.421.088.120] +
Diarrhea, Infantile [C23.888.821.214.500]
Child Health Services [N02.421.143.130] +
Counseling [N02.421.143.303]
Growth [G07.574.249] +
Micronutrients [D11.430]
Breast Feeding [G06.696.259.750.500]

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms


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