SHINE Sanitation, Hygiene, Infant Nutrition Efficacy Project (SHINE)
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|ClinicalTrials.gov Identifier: NCT01824940|
Recruitment Status : Completed
First Posted : April 5, 2013
Last Update Posted : July 26, 2018
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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).
|Condition or disease||Intervention/treatment||Phase|
|Growth; Stunting, Nutritional Anemia||Behavioral: Standard care Other: WASH Dietary Supplement: Infant and young child feeding Other: WASH and Nutrition||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5280 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Given the nature of the intervention, masking to treatment group is not possible.|
|Official Title:||Sanitation, Hygiene, Infant Nutrition Efficacy Project|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||July 2017|
|Actual Study Completion Date :||July 31, 2017|
Placebo Comparator: Standard of Care
The Standard of Care interventions are the blanket interventions.
Behavioral: Standard care
Active Comparator: 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)
Active Comparator: 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)
Dietary Supplement: Infant and young child feeding
Other Name: Nutrition
Active Comparator: WASH and Nutrition
This arm receives a combination of all standard care interventions, all WASH and all IYCF interventions.
Other: WASH and Nutrition
WASH AND IYCF interventions
Other Name: WASH and IYCF
- Infant length at 18 months [ Time Frame: 18 months of age. Protocol and Statistical Analysis Plan are available at https://osf.io/w93hy. ]Recumbent length measured by length board
- Infant hemoglobin at 18 months [ Time Frame: 18 months ]Measured by Hemocue
- Infant environmental enteric dysfunction [ Time Frame: 1, 3, 6, 12 and 18 months of age ]Assessed in a subgroup of infants recruited to the EED substudy by assessing domains of the hypothesized EED pathway using biomarkers of intestinal structure and function (inflammation, regeneration, absorption and permeability); microbial translocation; systemic inflammation; and hormonal determinants of growth and anemia
- Infant weight, mid-upper arm circumference and head circumference [ Time Frame: At 18 months, and (with length) at intermediate time-points of 1, 3, 6 and 12 months ]Measured by standardized anthropometry protocols at each age
- To describe the Program Impact Pathways (PIP) linking implementation of each randomized intervention (WASH and IYCF) with length and hemoglobin concentrations [ Time Frame: Throughout follow-up ]Assessment of quality of VHW training and supervision; VHW Capacity, defined as a composite of attained knowledge, goal setting capacity, and achieved performance; Fidelity of intervention implementation, defined as degree of conformance with protocol specifications for both VHW and mother; Attained maternal knowledge and skills assessed by questionnaire and observation; Uptake or adoption of promoted behaviors by mothers and their households assessed by questionnaire and observation.
- Exclusive breastfeeding [ Time Frame: First 6 months of life ]To describe the prevalence of exclusive breastfeeding among all infants enrolled in the trial by maternal/infant HIV status.
- To evaluate the effect of the IYCF intervention on uptake of improved infant feeding practices by maternal/infant HIV status [ Time Frame: 6-18 months of age ]Infant diet quality as assessed by World Health Organization IYCF indicators ; infant nutrient intake from complementary foods assessed by 24 hour dietary recall; appropriate use of Nutributter from 6 to 18 months.
- To evaluate the effect of the WASH intervention on the 5 key behaviors it promotes by maternal/infant HIV status [ Time Frame: Throughout follow-up ]Proper disposal of animal and human feces; Handwashing with soap after fecal contact; Point-of-use chlorination of drinking water; Protecting children from ingestion of dirt and feces; Feeding baby freshly prepared foods, or reheating leftover food.
- Relative contributions of diarrhea vs EED [ Time Frame: Birth to 18 months ]To model the relative contributions of diarrheal disease and EED in mediating the effects of improved WASH on child length and hemoglobin concentrations, stratified by maternal/infant HIV status.
- To measure the strength of association between other potential causes of stunting and anemia (other than poor WASH or IYCF) with linear growth and hemoglobin [ Time Frame: Throughout follow-up ]Maternal schistosomiasis infection during pregnancy; Maternal HIV infection together with adherence to antiretroviral and cotrimoxazole regimens during pregnancy and lactation; Infant HIV infection or exposure, together with adherence to antiretroviral and/or cotrimoxazole regimens; Exposure to dietary mycotoxin contamination by the mother during pregnancy and lactation, and by the infant during complementary feeding.
- Infant diarrhea prevalence, incidence and severity [ Time Frame: 1 month to 18 months of age ]Assessed by 7-day morbidity history in all infants, and by daily morbidity diary in a subgroup of infants
- Child neurodevelopment [ Time Frame: 24 months of age ]Assessed by MacArthur-Bates Communication Developmental Inventory; Malawi Development Test (MDAT); A not B task; Delayed inhibition task; and Caregiver Child Interaction assessment in a subgroup of children
- Prevalence of mycotoxin exposure among mothers and infants [ Time Frame: Maternal samples assessed at baseline; infant samples assessed birth to 18 months ]Detectable AFB1-lysine in plasma and detectable AFM1 in urine; detectable Fumonisin B1 in urine; detectable deoxynivalenol in urine; detectable zearalenone in urine; detectable ochratoxin A in urine; detectable T-2 in urine
- MAternal and infant microbiota [ Time Frame: Maternal samples from baseline and 1 month postpartum; infant samples birth to 18 months of age ]16S rRNA and whole genome sequencing of DNA and RNA from stool to define th composition and function of the microbial community that inhabits the human intestine.
- Infant rotavirus vaccine and polio vaccine immunogenicity [ Time Frame: 1 and 3 months of age ]Measurement of rotavirus IgA titre in plasma, measurement of polio virus IgA titre in plasma
- Adverse birth outcomes: miscarriage, still birth, small for gestational age, preterm delivery, neonatal death [ Time Frame: Maternal pregnancy exposures, infant outcomes through 1 month postpartum ]Association of maternal exposures during pregnancy (EED, anemia, mycotoxin exposure, HIV infection, schistosomiasis infection) on each adverse birth outcome
- Bioimpedance analysis, skinfold thicknesses and leg length measurement [ Time Frame: 24 months in a subsample of infants ]Assess the impact of the randomized interventions on infant body composition. analysis plan at https://osf.io/t9zd4
- Observational study of WASH and non-WASH infants [ Time Frame: About 14 months of age ]90 WASH and 90 non-WASH infants will undergo 6 h structured observation to directly observe and assess intervention impact on hygiene behaviors
- Assess metabolic pathways of pathogenesis of stunting [ Time Frame: 12 month urines; longitudinal stools from 150 mother-infant pairs from 32 week gestation, and 1,3,6,12,and 18 months postpartum ]Urine and stool samples analysed by untargeted metabolomics
- Friendship Bench for treatment of depression: a pilot study [ Time Frame: August 2018 - January 2019 (about a year after the end of the trial). ]30 SHINE mothers will be recruited to pilot a depression intervention for feasibility and acceptability
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|Ages Eligible for Study:||15 Years to 49 Years (Child, Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
Study participants will be women who are rural residents of Chirumanzu or Shurugwi districts in Zimbabwe and who become pregnant during the enrollment period of the trial and are identified and consent to participation during pregnancy, and their live born infants. A total of 5280 women will be enrolled.
Pregnant women residing in the study districts, whose pregnancy is confirmed by a urine pregnancy test.
- 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)
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): NCT01824940
|Principal Investigator:||Jean H Humphrey, ScD||Johns Hopkins University Bloomberg School of Public Health|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Jean Humphrey, Professor, Johns Hopkins Bloomberg School of Public Health|
|Other Study ID Numbers:||
R01HD060338 ( U.S. NIH Grant/Contract )
|First Posted:||April 5, 2013 Key Record Dates|
|Last Update Posted:||July 26, 2018|
|Last Verified:||July 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
Cluster randomized trial
Water Sanitation Hygiene