SHINE Sanitation, Hygiene, Infant Nutrition Efficacy Project

NCT01824940 | Completed DMC

• 2 other identifiers: IRB00004205R01HD060338
• Study Type: interventional
• Target: 5,280
• Locations: 1 country
• Sites: 1

Brief Summary

Globally, stunting affects 26% (165 million) of under-5-year children, underlies 15-17% of their mortality and leads to long-term cognitive deficits, fewer years and poorer performance in school, lower adult economic productivity, and a higher risk that their own children will also be stunted, perpetuating the problem into future generations. Stunting begins antenatally and peaks at 18-24 months of postnatal life, when mean length-for-age Z-score (LAZ) is about -2.0 among children living in Africa and Asia. Improving the diets of young children can reduce stunting, though, at best, only by about one-third. Frequent diarrheal illness has also been implicated. However, the effect of diarrhea on permanent stunting is relatively small, maybe because children grow at "catch-up" rates between illness episodes. The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial is motivated by a 2-part premise:

• A major cause of child stunting and anemia is Environmental Enteric Dysfunction (EED). EED is a subclinical disorder of the small intestine, which is virtually ubiquitous among asymptomatic people living in low-income settings throughout the world. EED is characterized by increased permeability which facilitates microbial translocation into the systemic circulation and triggers chronic immune activation.
• The primary cause of EED is infant ingestion of fecal microbes due to living in conditions of poor quality and quantity of water, sanitation, and hygiene (WASH).

Conditions

Growth; Stunting, Nutritional; Anemia

Keywords

Cluster randomized trial; Nutrition; Water Sanitation Hygiene; Environmental enteropathy

Outcome Measures

Primary Outcomes (2)

• Infant length at 18 months

  Recumbent length measured by length board

  18 months of age. Protocol and Statistical Analysis Plan are available at https://osf.io/w93hy.

• Infant hemoglobin at 18 months

  Measured by Hemocue

  18 months

Secondary Outcomes (18)

• Infant environmental enteric dysfunction

  1, 3, 6, 12 and 18 months of age

• Infant weight, mid-upper arm circumference and head circumference

  At 18 months, and (with length) at intermediate time-points of 1, 3, 6 and 12 months

• To describe the Program Impact Pathways (PIP) linking implementation of each randomized intervention (WASH and IYCF) with length and hemoglobin concentrations

  Throughout follow-up

• Exclusive breastfeeding

  First 6 months of life

• To evaluate the effect of the IYCF intervention on uptake of improved infant feeding practices by maternal/infant HIV status

  6-18 months of age

Study Arms (4)

Standard of Care

PLACEBO COMPARATOR

The Standard of Care interventions are the blanket interventions.

Behavioral: Standard care

WASH

ACTIVE COMPARATOR

One of two active interventions to be studied in this 2X2 (two by two) Factorial trial: Intervention 1: a package of interventions to improve household sanitation and hygiene (WASH)

Other: WASH

Nutrition

ACTIVE COMPARATOR

One of two active interventions to be studied in this 2X2 Factorial trial: Intervention 2: a package of interventions to improve infant and young child feeding (IYCF)

Dietary Supplement: Infant and young child feeding

WASH and Nutrition

ACTIVE COMPARATOR

This arm receives a combination of all standard care interventions, all WASH and all IYCF interventions.

Other: WASH and Nutrition

Interventions

Standard care BEHAVIORAL

Standard Care: * Exclusive breastfeeding promotion for all infants, birth to 6 months * Strengthened PMTCT (prevention of mother to child transmission of HIV) services * Strengthened Village Health Worker system

Standard of Care

WASH OTHER

WASH: * Standard care interventions * Provide household ventilated pit latrine, water treatment solution, and monthly liquid soap, two hand-washing facilities and protected infant play space * Provide interpersonal communication interventions promoting feces disposal in a latrine, HWWS (hand washing with soap), drinking water treatment, hygienic weaning food preparation, and preventing babies from putting dirt and animal feces in their mouths.

WASH

Infant and young child feeding DIETARY_SUPPLEMENT

IYCF: * Standard care interventions * Provide 20 g/d Nutributter from 6-18 months * Provide interpersonal communication interventions promoting optimal use of locally available foods for complementary feeding after 6 months, continued breastfeeding and feeding during illness.

Also known as: Nutrition

Nutrition

WASH and Nutrition OTHER

WASH AND IYCF interventions * Standard care interventions * All WASH interventions * All IYCF interventions

Also known as: WASH and IYCF

WASH and Nutrition

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant women residing in the study districts, whose pregnancy is confirmed by a urine pregnancy test.

You may not qualify if:

• Women residing in the study districts who become pregnant during the enrollment period but do not consent to join the trial
• Women who reside in urban areas of these two districts
• Infants with major non-fatal abnormalities will not be excluded from study procedures, but will be excluded from the final analytic sample if the abnormality is likely to directly affect gut health/function or stature (e.g. neural tube defects, cerebral palsy, Down syndrome)

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Ministry of Health and Child Welfare, Zimbabwe: collaborator
• Zvitambo: collaborator
• Cornell University: collaborator
• University of London: collaborator
• Bill and Melinda Gates Foundation: collaborator
• Department for International Development, United Kingdom: collaborator
• Wellcome Trust: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Zvitambo

Harare, Zimbabwe

Location

Related Publications (36)

• Humphrey JH. Child undernutrition, tropical enteropathy, toilets, and handwashing. Lancet. 2009 Sep 19;374(9694):1032-1035. doi: 10.1016/S0140-6736(09)60950-8. No abstract available.

  PMID: 19766883 BACKGROUND

• Prendergast AJ, Rukobo S, Chasekwa B, Mutasa K, Ntozini R, Mbuya MN, Jones A, Moulton LH, Stoltzfus RJ, Humphrey JH. Stunting is characterized by chronic inflammation in Zimbabwean infants. PLoS One. 2014 Feb 18;9(2):e86928. doi: 10.1371/journal.pone.0086928. eCollection 2014.

  PMID: 24558364 BACKGROUND

• Paul KH, Muti M, Chasekwa B, Mbuya MN, Madzima RC, Humphrey JH, Stoltzfus RJ. Complementary feeding messages that target cultural barriers enhance both the use of lipid-based nutrient supplements and underlying feeding practices to improve infant diets in rural Zimbabwe. Matern Child Nutr. 2012 Apr;8(2):225-38. doi: 10.1111/j.1740-8709.2010.00265.x. Epub 2010 Aug 4.

  PMID: 22405701 BACKGROUND

• Mbuya MN, Humphrey JH, Majo F, Chasekwa B, Jenkins A, Israel-Ballard K, Muti M, Paul KH, Madzima RC, Moulton LH, Stoltzfus RJ. Heat treatment of expressed breast milk is a feasible option for feeding HIV-exposed, uninfected children after 6 months of age in rural Zimbabwe. J Nutr. 2010 Aug;140(8):1481-8. doi: 10.3945/jn.110.122457. Epub 2010 Jun 23.

  PMID: 20573941 BACKGROUND

• Ngure FM, Humphrey JH, Mbuya MN, Majo F, Mutasa K, Govha M, Mazarura E, Chasekwa B, Prendergast AJ, Curtis V, Boor KJ, Stoltzfus RJ. Formative research on hygiene behaviors and geophagy among infants and young children and implications of exposure to fecal bacteria. Am J Trop Med Hyg. 2013 Oct;89(4):709-16. doi: 10.4269/ajtmh.12-0568. Epub 2013 Sep 3.

  PMID: 24002485 BACKGROUND

• Mupfudze TG, Stoltzfus RJ, Rukobo S, Moulton LH, Humphrey JH, Prendergast AJ; SHINE Project Team. Hepcidin decreases over the first year of life in healthy African infants. Br J Haematol. 2014 Jan;164(1):150-3. doi: 10.1111/bjh.12567. Epub 2013 Sep 20. No abstract available.

  PMID: 24112078 BACKGROUND

• Ngure FM, Reid BM, Humphrey JH, Mbuya MN, Pelto G, Stoltzfus RJ. Water, sanitation, and hygiene (WASH), environmental enteropathy, nutrition, and early child development: making the links. Ann N Y Acad Sci. 2014 Jan;1308:118-128. doi: 10.1111/nyas.12330.

  PMID: 24571214 BACKGROUND

• Palha De Sousa CA, Brigham T, Chasekwa B, Mbuya MN, Tielsch JM, Humphrey JH, Prendergast AJ. Dosing of praziquantel by height in sub-Saharan African adults. Am J Trop Med Hyg. 2014 Apr;90(4):634-7. doi: 10.4269/ajtmh.13-0252. Epub 2014 Mar 3.

  PMID: 24591432 BACKGROUND

• Gough EK, Moodie EE, Prendergast AJ, Johnson SM, Humphrey JH, Stoltzfus RJ, Walker AS, Trehan I, Gibb DM, Goto R, Tahan S, de Morais MB, Manges AR. The impact of antibiotics on growth in children in low and middle income countries: systematic review and meta-analysis of randomised controlled trials. BMJ. 2014 Apr 15;348:g2267. doi: 10.1136/bmj.g2267.

  PMID: 24735883 BACKGROUND

• Desai A, Mbuya MN, Chigumira A, Chasekwa B, Humphrey JH, Moulton LH, Pelto G, Gerema G, Stoltzfus RJ; SHINE Study Team. Traditional oral remedies and perceived breast milk insufficiency are major barriers to exclusive breastfeeding in rural Zimbabwe. J Nutr. 2014 Jul;144(7):1113-9. doi: 10.3945/jn.113.188714. Epub 2014 May 14.

  PMID: 24828026 BACKGROUND

• Jones AD, Rukobo S, Chasekwa B, Mutasa K, Ntozini R, Mbuya MN, Stoltzfus RJ, Humphrey JH, Prendergast AJ. Acute illness is associated with suppression of the growth hormone axis in Zimbabwean infants. Am J Trop Med Hyg. 2015 Feb;92(2):463-70. doi: 10.4269/ajtmh.14-0448. Epub 2014 Dec 22.

  PMID: 25535308 BACKGROUND

• Mupfudze TG, Stoltzfus RJ, Rukobo S, Moulton LH, Humphrey JH, Prendergast AJ; SHINE Trial Team; Jones AD, Manges A, Mangwadu G, Maluccio JA, Mbuya MN, Ntozini R, Tielsch JM. Plasma Concentrations of Hepcidin in Anemic Zimbabwean Infants. PLoS One. 2015 Aug 7;10(8):e0135227. doi: 10.1371/journal.pone.0135227. eCollection 2015.

  PMID: 26252205 BACKGROUND

• Gough EK, Stephens DA, Moodie EE, Prendergast AJ, Stoltzfus RJ, Humphrey JH, Manges AR. Linear growth faltering in infants is associated with Acidaminococcus sp. and community-level changes in the gut microbiota. Microbiome. 2015 Jun 13;3:24. doi: 10.1186/s40168-015-0089-2. eCollection 2015.

  PMID: 26106478 BACKGROUND

• Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial Team; Humphrey JH, Jones AD, Manges A, Mangwadu G, Maluccio JA, Mbuya MN, Moulton LH, Ntozini R, Prendergast AJ, Stoltzfus RJ, Tielsch JM. The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial: Rationale, Design, and Methods. Clin Infect Dis. 2015 Dec 15;61 Suppl 7(Suppl 7):S685-702. doi: 10.1093/cid/civ844.

  PMID: 26602296 BACKGROUND

• Mbuya MN, Tavengwa NV, Stoltzfus RJ, Curtis V, Pelto GH, Ntozini R, Kambarami RA, Fundira D, Malaba TR, Maunze D, Morgan P, Mangwadu G, Humphrey JH; Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial Team. Design of an Intervention to Minimize Ingestion of Fecal Microbes by Young Children in Rural Zimbabwe. Clin Infect Dis. 2015 Dec 15;61 Suppl 7(Suppl 7):S703-9. doi: 10.1093/cid/civ845.

  PMID: 26602297 BACKGROUND

• Desai A, Smith LE, Mbuya MN, Chigumira A, Fundira D, Tavengwa NV, Malaba TR, Majo FD, Humphrey JH, Stoltzfus RJ; Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial Team. The SHINE Trial Infant Feeding Intervention: Pilot Study of Effects on Maternal Learning and Infant Diet Quality in Rural Zimbabwe. Clin Infect Dis. 2015 Dec 15;61 Suppl 7(Suppl 7):S710-5. doi: 10.1093/cid/civ846.

  PMID: 26602298 BACKGROUND

• Ntozini R, Marks SJ, Mangwadu G, Mbuya MN, Gerema G, Mutasa B, Julian TR, Schwab KJ, Humphrey JH, Zungu LI; Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial Team. Using Geographic Information Systems and Spatial Analysis Methods to Assess Household Water Access and Sanitation Coverage in the SHINE Trial. Clin Infect Dis. 2015 Dec 15;61 Suppl 7(Suppl 7):S716-25. doi: 10.1093/cid/civ847.

  PMID: 26602299 BACKGROUND

• Prendergast AJ, Humphrey JH, Mutasa K, Majo FD, Rukobo S, Govha M, Mbuya MN, Moulton LH, Stoltzfus RJ; Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial Team. Assessment of Environmental Enteric Dysfunction in the SHINE Trial: Methods and Challenges. Clin Infect Dis. 2015 Dec 15;61 Suppl 7(Suppl 7):S726-32. doi: 10.1093/cid/civ848.

  PMID: 26602300 BACKGROUND

• Mbuya MN, Jones AD, Ntozini R, Humphrey JH, Moulton LH, Stoltzfus RJ, Maluccio JA; Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial Team. Theory-Driven Process Evaluation of the SHINE Trial Using a Program Impact Pathway Approach. Clin Infect Dis. 2015 Dec 15;61 Suppl 7(Suppl 7):S752-8. doi: 10.1093/cid/civ716.

  PMID: 26602304 BACKGROUND

• Mbuya MN, Humphrey JH. Preventing environmental enteric dysfunction through improved water, sanitation and hygiene: an opportunity for stunting reduction in developing countries. Matern Child Nutr. 2016 May;12 Suppl 1(Suppl 1):106-20. doi: 10.1111/mcn.12220. Epub 2015 Nov 6.

  PMID: 26542185 BACKGROUND

• Smith LE, Prendergast AJ, Turner PC, Humphrey JH, Stoltzfus RJ. Aflatoxin Exposure During Pregnancy, Maternal Anemia, and Adverse Birth Outcomes. Am J Trop Med Hyg. 2017 Apr;96(4):770-776. doi: 10.4269/ajtmh.16-0730.

  PMID: 28500823 BACKGROUND

• Piper JD, Mazhanga C, Mwapaura M, Mapako G, Mapurisa I, Mashedze T, Munyama E, Kuona M, Mashiri T, Sibanda K, Matemavi D, Tichagwa M, Nyoni S, Saidi A, Mangwende M, Mbewe G, Chidhanguro D, Mpofu E, Tome J, Mutasa B, Chasekwa B, Njovo H, Nyachowe C, Muchekeza M, Sauramba V, Gladstone MJ, Wells JC, Allen E, Moulton LH, Smuk M, Humphrey JH, Langhaug LF, Tavengwa NV, Ntozini R, Prendergast AJ. School-age growth and development following infant feeding and/or water, sanitation, and hygiene interventions in rural Zimbabwe: long-term follow-up of a cluster-randomised trial. EClinicalMedicine. 2024 Nov 22;78:102946. doi: 10.1016/j.eclinm.2024.102946. eCollection 2024 Dec.

  PMID: 39640932 DERIVED

• Piper JD, Mazhanga C, Mwapaura M, Mapako G, Mapurisa I, Mashedze T, Munyama E, Kuona M, Mashiri T, Sibanda K, Matemavi D, Tichagwa M, Nyoni S, Saidi A, Mangwende M, Chidhanguro D, Mpofu E, Tome J, Mbewe G, Mutasa B, Chasekwa B, Njovo H, Nyachowe C, Muchekeza M, Mutasa K, Sauramba V, Evans C, Gladstone MJ, Wells JC, Allen E, Smuk M, Humphrey JH, Langhaug LF, Tavengwa NV, Ntozini R, Prendergast AJ. Growth, physical, and cognitive function in children who are born HIV-free: School-age follow-up of a cluster-randomised trial in rural Zimbabwe. PLoS Med. 2024 Oct 11;21(10):e1004347. doi: 10.1371/journal.pmed.1004347. eCollection 2024 Oct.

  PMID: 39392862 DERIVED

• Evans C, Mutasa K, Rukobo S, Govha M, Mushayanembwa P, Chasekwa B, Majo FD, Tavengwa NV, Broad J, Noble C, Gough EK, Kelly P, Bourke CD, Humphrey JH, Ntozini R, Prendergast AJ. Inflammation and cytomegalovirus viremia during pregnancy drive sex-differentiated differences in mortality and immune development in HIV-exposed infants. Nat Commun. 2024 Apr 17;15(1):2909. doi: 10.1038/s41467-023-44166-2.

  PMID: 38632279 DERIVED

• Noble C, Mooney C, Makasi R, Ntozini R, Majo FD, Church JA, Tavengwa NV, Prendergast AJ, Humphrey JH; Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial Team. Antenatal and delivery practices and neonatal mortality amongst women with institutional and non-institutional deliveries in rural Zimbabwe: observational data from a cluster randomized trial. BMC Pregnancy Childbirth. 2022 Dec 30;22(1):981. doi: 10.1186/s12884-022-05282-x.

  PMID: 36585673 DERIVED

• Mutasa K, Ntozini R, Mbuya MNN, Rukobo S, Govha M, Majo FD, Tavengwa N, Smith LE, Caulfield L, Swann JR, Stoltzfus RJ, Moulton LH, Humphrey JH, Gough EK, Prendergast AJ. Biomarkers of environmental enteric dysfunction are not consistently associated with linear growth velocity in rural Zimbabwean infants. Am J Clin Nutr. 2021 May 8;113(5):1185-1198. doi: 10.1093/ajcn/nqaa416.

  PMID: 33740052 DERIVED

• Ntozini R, Chandna J, Evans C, Chasekwa B, Majo FD, Kandawasvika G, Tavengwa NV, Mutasa B, Mutasa K, Moulton LH, Humphrey JH, Gladstone MJ, Prendergast AJ; SHINE Trial Team. Early child development in children who are HIV-exposed uninfected compared to children who are HIV-unexposed: observational sub-study of a cluster-randomized trial in rural Zimbabwe. J Int AIDS Soc. 2020 May;23(5):e25456. doi: 10.1002/jia2.25456.

  PMID: 32386127 DERIVED

• Chandna J, Ntozini R, Evans C, Kandawasvika G, Chasekwa B, Majo F, Mutasa K, Tavengwa N, Mutasa B, Mbuya M, Moulton LH, Humphrey JH, Prendergast A, Gladstone M. Effects of improved complementary feeding and improved water, sanitation and hygiene on early child development among HIV-exposed children: substudy of a cluster randomised trial in rural Zimbabwe. BMJ Glob Health. 2020 Jan 13;5(1):e001718. doi: 10.1136/bmjgh-2019-001718. eCollection 2020.

  PMID: 32133164 DERIVED

• Evans C, Chasekwa B, Ntozini R, Majo FD, Mutasa K, Tavengwa N, Mutasa B, Mbuya MNN, Smith LE, Stoltzfus RJ, Moulton LH, Humphrey JH, Prendergast AJ; Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial Team. Mortality, Human Immunodeficiency Virus (HIV) Transmission, and Growth in Children Exposed to HIV in Rural Zimbabwe. Clin Infect Dis. 2021 Feb 16;72(4):586-594. doi: 10.1093/cid/ciaa076.

  PMID: 31974572 DERIVED

• Murenjekwa W, Makasi R, Ntozini R, Chasekwa B, Mutasa K, Moulton LH, Tielsch JM, Humphrey JH, Smith LE, Prendergast AJ, Bourke CD. Determinants of Urogenital Schistosomiasis Among Pregnant Women and its Association With Pregnancy Outcomes, Neonatal Deaths, and Child Growth. J Infect Dis. 2021 Apr 23;223(8):1433-1444. doi: 10.1093/infdis/jiz664.

  PMID: 31832636 DERIVED

• Church JA, Rogawski McQuade ET, Mutasa K, Taniuchi M, Rukobo S, Govha M, Lee B, Carmolli MP, Chasekwa B, Ntozini R, McNeal MM, Moulton LH, Kirkpatrick BD, Liu J, Houpt ER, Humphrey JH, Platts-Mills JA, Prendergast AJ. Enteropathogens and Rotavirus Vaccine Immunogenicity in a Cluster Randomized Trial of Improved Water, Sanitation and Hygiene in Rural Zimbabwe. Pediatr Infect Dis J. 2019 Dec;38(12):1242-1248. doi: 10.1097/INF.0000000000002485.

  PMID: 31738342 DERIVED

• Mbuya MNN, Matare CR, Tavengwa NV, Chasekwa B, Ntozini R, Majo FD, Chigumira A, Chasokela CMZ, Prendergast AJ, Moulton LH, Stoltzfus RJ, Humphrey JH; SHINE Trial Team. Early Initiation and Exclusivity of Breastfeeding in Rural Zimbabwe: Impact of a Breastfeeding Intervention Delivered by Village Health Workers. Curr Dev Nutr. 2019 Feb 28;3(4):nzy092. doi: 10.1093/cdn/nzy092. eCollection 2019 Apr.

  PMID: 30937421 DERIVED

• Gladstone MJ, Chandna J, Kandawasvika G, Ntozini R, Majo FD, Tavengwa NV, Mbuya MNN, Mangwadu GT, Chigumira A, Chasokela CM, Moulton LH, Stoltzfus RJ, Humphrey JH, Prendergast AJ; SHINE Trial Team. Independent and combined effects of improved water, sanitation, and hygiene (WASH) and improved complementary feeding on early neurodevelopment among children born to HIV-negative mothers in rural Zimbabwe: Substudy of a cluster-randomized trial. PLoS Med. 2019 Mar 21;16(3):e1002766. doi: 10.1371/journal.pmed.1002766. eCollection 2019 Mar.

  PMID: 30897095 DERIVED

• Church JA, Rukobo S, Govha M, Lee B, Carmolli MP, Chasekwa B, Ntozini R, Mutasa K, McNeal MM, Majo FD, Tavengwa NV, Moulton LH, Humphrey JH, Kirkpatrick BD, Prendergast AJ. The Impact of Improved Water, Sanitation, and Hygiene on Oral Rotavirus Vaccine Immunogenicity in Zimbabwean Infants: Substudy of a Cluster-randomized Trial. Clin Infect Dis. 2019 Nov 27;69(12):2074-2081. doi: 10.1093/cid/ciz140.

  PMID: 30770931 DERIVED

• Prendergast AJ, Chasekwa B, Evans C, Mutasa K, Mbuya MNN, Stoltzfus RJ, Smith LE, Majo FD, Tavengwa NV, Mutasa B, Mangwadu GT, Chasokela CM, Chigumira A, Moulton LH, Ntozini R, Humphrey JH; SHINE Trial Team. Independent and combined effects of improved water, sanitation, and hygiene, and improved complementary feeding, on stunting and anaemia among HIV-exposed children in rural Zimbabwe: a cluster-randomised controlled trial. Lancet Child Adolesc Health. 2019 Feb;3(2):77-90. doi: 10.1016/S2352-4642(18)30340-7. Epub 2018 Dec 18.

  PMID: 30573417 DERIVED

• Humphrey JH, Mbuya MNN, Ntozini R, Moulton LH, Stoltzfus RJ, Tavengwa NV, Mutasa K, Majo F, Mutasa B, Mangwadu G, Chasokela CM, Chigumira A, Chasekwa B, Smith LE, Tielsch JM, Jones AD, Manges AR, Maluccio JA, Prendergast AJ; Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial Team. Independent and combined effects of improved water, sanitation, and hygiene, and improved complementary feeding, on child stunting and anaemia in rural Zimbabwe: a cluster-randomised trial. Lancet Glob Health. 2019 Jan;7(1):e132-e147. doi: 10.1016/S2214-109X(18)30374-7.

  PMID: 30554749 DERIVED

MeSH Terms

Conditions

Growth Disorders; Anemia

Interventions

Standard of Care; Nutritional Status; Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques

Study Officials

• Jean H Humphrey, ScD

  Johns Hopkins University Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Given the nature of the intervention, masking to treatment group is not possible.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: April 5, 2013
• Study Start: November 1, 2012
• Primary Completion: July 1, 2017
• Study Completion: July 31, 2017
• Last Updated: July 26, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

ZI (1)