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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: PACTR
Last refreshed on: 29 May 2023
Main ID:  PACTR201410000859336
Date of registration: 22/07/2014
Prospective Registration: Yes
Primary sponsor: Islamic Development Bank
Public title: Weaning food hygiene intervention, Gambia project
Scientific title: 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: 25/09/2014
Target sample size: 30
Recruitment status: Complete
URL:  https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=859
Study type:  Interventional
Study design:  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  
Phase:  Not Applicable
Countries of recruitment
Gambia
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name: Semira     Manaseki Holland
Address:  Dept Public Health, School Health and Population Secienes, Univ Birmingham Rm G32, Public Health Bldng, Edgbaston B15 2TT Birmingham United Kingdom
Telephone: +44 121 414 4533
Email: s.manasekiholland@bham.ac.uk
Affiliation:  Clinical Senior Lecturer
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
Diarrhoea and respiratory infection

Diarrhoea and respiratory infection
Intervention(s)
Community weaning food hygiene health education program for behavioural change of mothers of
Health education
Primary Outcome(s)
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.)
Secondary Outcome(s)
Proportion of all observed boiling of water ready for drinking of child
Contamination of weaning food and water (Coliform coutns
diarrhoea diagnosis entered in clinic register for 6-24m children from study villlages
Reported diarrhea by mothers for the past 7 days . Admission during the most recent illness of diarrhoea
Respiratory infection diagnosis entered in clinic register for 6-24m children from study villages
Reported Respiratory Tract Infections (RTI) by mothers for the past 7 days
Secondary ID(s)
Source(s) of Monetary Support
UNICEF
SHARE
Islamic Development Bank
Uiversity of Birmingham
Secondary Sponsor(s)
University of Birmingham
Ethics review
Status: Approved
Approval date: 24/09/2014
Contact:
Scientific Coordinating Committee, Fajara, Gambia
Results
Results available:
Date Posted:
Date Completed:
URL:
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