SHINE Sanitation, Hygiene, Infant Nutrition Efficacy Project

NCT ID: NCT01824940

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2017-07-31

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).

Detailed Description

The Sanitation Hygiene Infant Nutrition Efficacy ("SHINE") trial will test the effects of two packages of interventions: 1) improved water, sanitation and hygiene (WASH) and 2) improved infant and young child feeding (IYCF) on child stunting and anemia in the first 18 months of life. The trial will be conducted in rural Zimbabwe where WASH is poor, food insecurity high, and where about 15% of pregnant women are infected with HIV. The study will enroll 5282 women early in pregnancy and follow them and their infants until 18 months after delivery. The study will be a cluster-randomized controlled trial: two entire districts in central Zimbabwe have been divided into 212 geographic areas, each of about 100 households. The areas will be randomly allocated (that is, assigned by according to chance like the flip of a coin) to one of four interventions:

1. Improved WASH (a ventilated pit latrine, hand washing facilities with soap, drinking water treatment, a protected play space and health lessons to adopt improved hygiene behaviors)

2. Improved Infant Nutrition (health lessons on best infant feeding practices and a nutritional supplement (Nutributter) to be fed daily to babies from 6 to 18 months).

3. Improved WASH and Infant Nutrition (both interventions)

4. Standard of Care

All women living in the two districts who become pregnant during the recruitment period of the study will be invited to enroll. They will receive one of the 4 packages of interventions according to the area where they live. Health lessons will be given by Village Health Workers. Latrines and hand washing facilities will be constructed by building teams. Mothers will be followed up by research nurses at 7 months gestation, and at 1, 3, 6, 12, and 18 months after delivery. Primary outcomes are infant height and hemoglobin at 18 months of age.

Within SHINE we will measure two causal pathways: the biomedical pathway and the program impact pathway.

The biomedical pathway comprises the infant biologic responses to the WASH and IYCF interventions that ultimately result in attained stature and hemoglobin concentration at 18 months of age; it will be elucidated by measuring biomarkers of intestinal structure and function (inflammation, regeneration, absorption and permeability); microbial translocation; systemic inflammation; and hormonal determinants of growth and anemia among a subgroup of infants enrolled in an EED substudy. The investigators will also ask these mothers to record daily any episodes of diarrhea; blood/mucus in the stool; cough; fast or difficult breathing; fever; and lethargy preventing breastfeeding, that the child has between 1 month and 18 months of age. A subgroup of infants will also have stool samples collected during diarrhoeal episodes to evaluate reductions in pathogen-specific diarrhoea following WASH interventions.

Since the mothers enrolled in SHINE will have lived in unsanitary living conditions throughout their lives, it is anticipated that most will have some degree of EED themselves. It is hypothesized that resulting chronic inflammation contributes to adverse birth outcomes, such as prematurity and low birth weight. This question will be investigated through an observational design. For all mothers enrolled in SHINE, the sugar absorption test described above will be conducted and specimens of saliva, stool and blood collected and archived at the 10-12 week gestation visit for subsequent assessment of EED biomarkers. The association of severity of EED with risk of adverse birth outcomes (low birth length and weight; miscarriage, stillbirth, and premature delivery) will be assessed.

The program impact pathway comprises the series of processes and behaviors linking implementation of the interventions with the two child health outcomes; it will be modeled using measures of fidelity of intervention delivery and household uptake of promoted behaviors and practices. We will also measure a range of household and individual characteristics, social interactions, and maternal capabilities for childcare, which we hypothesize will explain heterogeneity along these pathways.

Conditions

Growth; Stunting, Nutritional; Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard of Care

The Standard of Care interventions are the blanket interventions.

Group Type: PLACEBO_COMPARATOR

Standard care

Intervention Type: 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

WASH

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)

Group Type: ACTIVE_COMPARATOR

WASH

Intervention Type: 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.

Nutrition

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)

Group Type: ACTIVE_COMPARATOR

Infant and young child feeding

Intervention Type: 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.

WASH and Nutrition

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

Group Type: ACTIVE_COMPARATOR

WASH and Nutrition

Intervention Type: OTHER

WASH AND IYCF interventions

• Standard care interventions
• All WASH interventions
• All IYCF interventions

Interventions

Standard care

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

Intervention Type: BEHAVIORAL

WASH

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.

Intervention Type: OTHER

Infant and young child feeding

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.

Intervention Type: DIETARY_SUPPLEMENT

WASH and Nutrition

WASH AND IYCF interventions

• Standard care interventions
• All WASH interventions
• All IYCF interventions

Intervention Type: OTHER

Other Intervention Names

Nutrition; WASH and IYCF

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health and Child Welfare, Zimbabwe

OTHER

Sponsor Role: collaborator

Zvitambo

OTHER

Sponsor Role: collaborator

Cornell University

OTHER

Sponsor Role: collaborator

University of London

OTHER

Sponsor Role: collaborator

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

Department for International Development, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

Wellcome Trust

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Jean Humphrey

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean H Humphrey, ScD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University Bloomberg School of Public Health

Locations

Zvitambo

Harare, , Zimbabwe

Countries

Zimbabwe

References

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Reference Type: BACKGROUND

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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.

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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.

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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.

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Other Identifiers

R01HD060338

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00004205

Identifier Type: -

Identifier Source: org_study_id