SHINE Sanitation, Hygiene, Infant Nutrition Efficacy Project
Condition: Growth; Stunting, Nutritional; Anemia
MeSH terms: Growth Disorders
Study type: Interventional

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.
    

Intervention name(s): Standard care; WASH; Infant and young child feeding; WASH and Nutrition
Intervention type(s): Behavioral; Other; Dietary Supplement; Other
Intervention description(s): 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:
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.; 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 IYCF interventions
Standard care interventions
All WASH interventions
All IYCF interventions
Other intervention name(s): Nutrition; WASH and IYCF
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cluster randomized trial; Nutrition; Water Sanitation Hygiene; Environmental enteropathy