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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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26 June 2023 |
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Main ID: |
ISRCTN16001234 |
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Date of registration:
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08/05/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Piloting integrated nutritional, early childhood development and water, sanitation hygiene interventions
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Scientific title:
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Piloting scalable nutritional, psychosocial and environmental interventions for child growth and development |
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Date of first enrolment:
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01/06/2017 |
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Target sample size:
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260 |
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Recruitment status: |
Completed |
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URL:
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https://www.isrctn.com/ISRCTN16001234 |
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Study type:
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Interventional |
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Study design:
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Stage one: Formative study Stage two: Pilot community randomised controlled study (Prevention)
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Phase:
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Not Applicable
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Countries of recruitment
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Bangladesh
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Steve
Luby |
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Address:
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Stanford University
Y2E2, MC 4205
473 Via Ortega
94305
Stanford
United States of America |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Pregnant mothers and mothers of children <2 years of age in select villages in Khishoreganj district.
Exclusion criteria: Families planning to move.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Sub-optimal child development
Nutritional, Metabolic, Endocrine
Sub-optimal child development
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Intervention(s)
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Current interventions as of 16/09/2019:
Formative Research stage:
This study includes an initial period of formative research on each of the intervention components to make sure that the interventions are evidence based, feasible and acceptable within the community. During this phase the integrated WASH, nutrition, lead poisoning and stimulation curriculum is developed. Community members are involved in focus group discussions, interviews, and participate in initial versions of group and home sessions to gather feedback and asses areas for improvement.
Pilot study:
Following the formative research phase, eligible community members who consent to participate are enrolled in the nine month pilot study, with interventions based on the initial formative research period. The interventions are conducted by community health promoters. This includes promoting maternal nutrition (i.e. promoting a diverse diet of nutrient-dense food), child nutrition (i.e. encouraging breastfeeding and high nutrient diets), increasing psychosocial stimulation (i.e. providing coaching to mothers on how to engage with their children), reducing lead exposure (i.e. teaching about pathways to exposure) and improving water, sanitation and hygiene (i.e. encourage handwashing, improving latrines, improving cooking methods).
Villages are randomly allocated to three different groups. Those in the first group (participants in 8 villages) are encouraged to attend fortnightly courtyard group meetings, those in an equally sized second group are visited by community health promoters once a month in their home as well as receive encouragement to attend monthly courtyard group meetings in between the monthly home visits. The last group (15 villages) act as the control group and they do not receive any interve
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Primary Outcome(s)
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1. Feasibility and acceptability of the interventions as assessed by qualitative feedback from the study population and study implementers occurs continuously throughout the study (both formative stage and pilot intervention)
2. Adoption of behavior change recommendations as assessed by surveys (through use of the Family Care Indicators (FCIs) as well as additional items from the Home Observation Measurement of the Environment (HOME) scale), spot checks, and structured observations at baseline and endline of the pilot intervention.
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Secondary Outcome(s)
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Child development is measured using the Ages and Stages Questionnaire (ASQ) at baseline and endline of the pilot intervention.
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Source(s) of Monetary Support
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Bill and Melinda Gates Foundation
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Ethics review
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Status:
Approval date:
Contact:
Old ethics approval format; International Centre for Diarrhoeal Disease Research ICDDR, B Ethical Review Committee, 15/06/2016, ref: PR-16037
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/08/2018 |
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URL:
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