SHINE Sanitation, Hygiene, Infant Nutrition Efficacy Project (SHINE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Ministry of Health and Child Care, Zimbabwe
Zvitambo
Cornell University
University of London
Bill and Melinda Gates Foundation
Department for International Development, United Kingdom
Wellcome Trust
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Jean Humphrey, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01824940
First received: March 27, 2012
Last updated: September 28, 2015
Last verified: September 2015
  Purpose

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 Intervention
Growth; Stunting, Nutritional
Anemia
Behavioral: Standard care
Other: WASH
Dietary Supplement: Nutrition
Other: WASH and Nutrition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Sanitation, Hygiene, Infant Nutrition Efficacy Project

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Infant length at 18 months [ Time Frame: 18 months of age ] [ Designated as safety issue: No ]
    Recumbent length measured by length board

  • Infant hemoglobin at 18 months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Measured by Hemocue


Secondary Outcome Measures:
  • Infant environmental enteric dysfunction [ Time Frame: 1, 3, 6, 12 and 18 months of age ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Assessed by 7-day morbidity history in all infants, and by daily morbidity diary in a subgroup of infants


Estimated Enrollment: 5272
Study Start Date: November 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Standard of Care
The Standard of Care interventions are the blanket interventions.
Behavioral: 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
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)

Other: 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.
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: Nutrition

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.
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

Sanitation/Hygiene AND Nutrition:

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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 5272 women will be enrolled.

Inclusion Criteria:

Women residing in the study districts under monthly prospective pregnancy surveillance of a Village Health Worker, who have a negative pregnancy test followed by a positive pregnancy test.

Exclusion Criteria:

  • Women residing in the study districts who were already pregnant when trial recruitment begins
  • 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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01824940

Locations
Zimbabwe
Zvitambo
Harare, Zimbabwe
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Ministry of Health and Child Care, Zimbabwe
Zvitambo
Cornell University
University of London
Bill and Melinda Gates Foundation
Department for International Development, United Kingdom
Wellcome Trust
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Jean H Humphrey, ScD Johns Hopkins University Bloomberg School of Public Health
  More Information

Publications:

Responsible Party: Jean Humphrey, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01824940     History of Changes
Other Study ID Numbers: IRB00004205  R01HD060338 
Study First Received: March 27, 2012
Last Updated: September 28, 2015
Health Authority: Zimbabwe: Medical Research Council

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Cluster randomized trial
Nutrition
Water Sanitation Hygiene
Environmental enteropathy

ClinicalTrials.gov processed this record on February 07, 2016