Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201410000859336 Date of Registration: 22/07/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Weaning food hygiene intervention, Gambia project
Official 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
Brief summary describing the background and objectives of the trial Diarrhoea is killing about 1.9 billion people in the world. Children less than 5 years of age are the worst affected in poor countries. There is evidence that weaning food contamination causes diarrhoea. Primary objectives To investigate the effect of Health Education program on: 1. Mother¿s compliance to hand washing before preparation of food, during cooking and feeding. 2. Mother¿s compliance to washing of utensils before serving food. 3. Mother¿s compliance to the practice of reheating weaning food after storage. Secondary objectives 4. The level of microbiological contamination in food and water ready for child drinking. 5. Mother¿s compliance to boiling water ready for child drinking. 6. Mother reported diarrhoea rates in study child Study setting The study will be conducted in Central River Region which is one of the 7 regions in the Gambia. Recruitment Village Weaning Food Hygiene Program: Thirty villages will be randomly selected from 55 meeting inclusion and exclusion criteria in Central River Region. Before randomisation, we will visit and get permission (consent) from the village heads by explaining the nature and the purpose of the project. Mothers for evaluation: All mothers or other carers of children 6 -24 months will be assessed for their compliance to the intervention messages. This evaluation will take place at the end of the 6 months intervention to assess the impact of the intervention as compared to the control arm. h After the 6 month evaluation follow-up, the following assessments were added: a) November 2015 - independent collection of clinic registry data on diarrhoea and respiratory infection presentations in children from our villages for the period after intervention b) At 2yr and 4 months years after intervention to repeat evaluation of all villages/cluster as with 6 months evaluation follow-up in 2015. Same clinic data from (a) also to be collected.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Diarrhoea and respiratory infection
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 25/09/2014
Actual trial start date 11/12/2017
Anticipated date of last follow up 30/06/2015
Actual Last follow-up date 16/10/2015
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
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 Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Community weaning food hygiene health education program for behavioural change of mothers of we will make 1 - 5 visits to the villages this will take 2 months in tervention Team of - 2 Public Health Officers - 2 Traditional communicators Schedule: Visiting villages: Day 1, Day 2, Day 17, Day 25 Community volunteers visit households between Day 2- 17 and Day 15 ¿ 25. We also made 5thvisit a month before evaluation. Activities in the village: ¿ Meeting village heads ¿ Dissemination of poster of SuperAmma ¿ Delivery of invitation cards to each of the households 15
Control Group Health education Short day campaign 1 Day A Public Health Officer will deliver Health education campaign using a flipchart on domestic water use. To enhance participation in study and mitigate place effect 15 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 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 6 Month(s) 24 Month(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/09/2014 Scientific Coordinating Committee, Fajara, Gambia
Ethics Committee Address
Street address City Postal code Country
Gambia, Fajara Banjul 00220 Gambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/09/2014 Scientific Coordinating Committee, Fajara, Gambia
Ethics Committee Address
Street address City Postal code Country
Gambia, Fajara Banjul 00220 Gambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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.) At all follow up visits
Secondary Outcome Proportion of all observed boiling of water ready for drinking of child At all follow up vistis
Secondary Outcome Contamination of weaning food and water (Coliform coutns At all follow up visits
Secondary Outcome Reported diarrhea by mothers for the past 7 days . Admission during the most recent illness of diarrhoea At all follow up visits
Secondary Outcome Reported Respiratory Tract Infections (RTI) by mothers for the past 7 days At all follow up visits
Secondary Outcome diarrhoea diagnosis entered in clinic register for 6-24m children from study villlages 8 months after intervention start covering the 8 month period; and 2.5 years after start of intervention covering 2.5 years
Secondary Outcome Respiratory infection diagnosis entered in clinic register for 6-24m children from study villages 8 months after intervention start covering the 8 month period; and 2.5 years after start of intervention covering 2.5 years
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Villages in northern part of Central River Region of the Gambia Central River Region in the Gambia, West Africa Banjul 00220 Gambia
FUNDING SOURCES
Name of source Street address City Postal code Country
Islamic Development Bank Jedda 21432 Jedda P.O Box 5925 Jeddah Saudi Arabia
Uiversity of Birmingham Edgbaston Birmingham B15 2TT United Kingdom
UNICEF Gambia Banjul Gambia
SHARE Keppel Street London WC1E 7HT United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Islamic Development Bank Jedda 21432 Jedda 636 Saudi Arabia Funding Agency
Secondary Sponsor University of Birmingham Edgbaston Birmingham B15 2TT United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
London School of Hygiene and Tropical Medicine Keppel street London WC1E 7HT United Kingdom
Ministry of Health, Gambia Fajara, Gambia Banjul 00220 Gambia
Ministry of Health, Gambia Quadrangle, Banjul Banjul 00220 Gambia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Semira Manaseki Holland s.manasekiholland@bham.ac.uk +44 121 414 4533
City Postal code Country Position/Affiliation
University of Birmingham B15 2TT United Kingdom Senior Lecturer
Role Name Email Phone Street address
Principal Investigator Karla Hemming K.HEMMING@bham.ac.uk 0121 4142955 University of Birmingham
City Postal code Country Position/Affiliation
Birmingham B15 2TT United Kingdom
Role Name Email Phone Street address
Scientific Enquiries Semira Manaseki Holland s.manasekiholland@bham.ac.uk +44 121 414 4533 Dept Public Health, School Health and Population Secienes, Univ Birmingham Rm G32, Public Health Bldng, Edgbaston
City Postal code Country Position/Affiliation
Birmingham B15 2TT United Kingdom Clinical Senior Lecturer
Role Name Email Phone Street address
Scientific Enquiries Buba Manjang bubamanjang@yahoo.com +44 7450405835 School Health and Population Sciences, College of Med and Dental Sciences, Univ Birmingham, Rm 125 Primary Care Unit
City Postal code Country Position/Affiliation
Birmingham B15 2TT United Kingdom Doctoral Researcher
REPORTING
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