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. |
Register:
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PACTR |
Last refreshed on:
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29 May 2023 |
Main ID: |
PACTR201410000859336 |
Date of registration:
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22/07/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Weaning food hygiene intervention, Gambia project
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Scientific title:
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Protocol for Cluster RCT investigating the effectiveness of behavioural change intervention in improving mother's weaning food preparation and handling practices in rural Gambia |
Date of first enrolment:
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25/09/2014 |
Target sample size:
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30 |
Recruitment status: |
Complete |
URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=859 |
Study type:
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Interventional |
Study design:
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Parallel: different groups receive different interventions at same time during study,Randomised,We will randomise, then stratified by (a) village according to north and south of Central River Region (b) size of village . The villages will be grouped randomly in fours and sequentially randomised within strata into control and intervention until all are done to allow for staggered implementation. Fifteen villages will be randomised to receive the intervention program; fifteen control villages randomised to receive the control program. ,Allocation will be determined by a statistician at university of birmingham being offsite of intervention area, who will send the sequence to the researcher
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Phase:
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Not Applicable
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Countries of recruitment
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Gambia
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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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Semira
Manaseki Holland |
Address:
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Dept Public Health, School Health and Population Secienes, Univ Birmingham Rm G32, Public Health Bldng, Edgbaston
B15 2TT
Birmingham
United Kingdom |
Telephone:
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+44 121 414 4533 |
Email:
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s.manasekiholland@bham.ac.uk |
Affiliation:
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Clinical Senior Lecturer |
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Key inclusion & exclusion criteria
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Inclusion criteria: Village: Inclusion criteria Villages which are geographically unattached from one another (at least 3km apart) Primary Health Care villages in Central River Region Villages with 200 to 450 people.
Mothers: All mothers of children 6 - 24 months who cooks and feeds child
Exclusion criteria: Village: Exclusion criteria Villages in which formative research was conducted Villages that do not consent to participate Villages benefitting from NaNA* or UNICEF interventions.
Mothers: Mothers who are not permanently resident in the village Anyone who do not consent to participate
Age minimum:
6 Month(s)
Age maximum:
24 Month(s)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diarrhoea and respiratory infection
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Diarrhoea and respiratory infection
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Intervention(s)
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Community weaning food hygiene health education program for behavioural change of mothers of
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Health education
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Primary Outcome(s)
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Proportion of key events (before food preparation, hands contaminated during cook, before feeding child) on which hands were observed cleaned with soap and water also observed (reheating thoroughly after storage of weaning food before first and second feedin of child, and wahsing of utensils before serving if dried on contaminated surfaces.)
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Secondary Outcome(s)
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Proportion of all observed boiling of water ready for drinking of child
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Contamination of weaning food and water (Coliform coutns
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diarrhoea diagnosis entered in clinic register for 6-24m children from study villlages
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Reported diarrhea by mothers for the past 7 days . Admission during the most recent illness of diarrhoea
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Respiratory infection diagnosis entered in clinic register for 6-24m children from study villages
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Reported Respiratory Tract Infections (RTI) by mothers for the past 7 days
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Source(s) of Monetary Support
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UNICEF
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SHARE
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Islamic Development Bank
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Uiversity of Birmingham
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Ethics review
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Status: Approved
Approval date: 24/09/2014
Contact:
Scientific Coordinating Committee, Fajara, Gambia
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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