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.: PACTR201803003159346 Date of Approval: 02/03/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Sannut Study
Official scientific title Evaluating the effectiveness of integrated sanitation and nutrition programs: Evidence from an RCT in Kitui, Kenya
Brief summary describing the background and objectives of the trial Child stunting is a persistent problem in many of Kenya¿s rural counties. Kitui County has one of the highest stunting rate in the nation, with 45% of the population exhibiting elements of stunting against the national prevalence of 26%. Factors related to poor sanitation and hygiene practices among caregivers of children exposed to fecal contamination through their environs, and poor nutrition practices put children at risk for stunting. Despite their shared objectives, sanitation and nutrition programs are often implemented separately. The SanNut study explored whether an integrated sanitation and nutrition program piloted in Kitui County would lead to better sanitation and nutrition behaviours and practices among caregivers of young children compared to a standard sanitation program.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Undernutrition, stunting
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/06/2016
Actual trial start date 04/07/2016
Anticipated date of last follow up 30/06/2017
Actual Last follow-up date 05/07/2017
Anticipated target sample size (number of participants) 4832
Actual target sample size (number of participants) 4436
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
Non-KEMRI 547 Kenya Medical Research Institute
OPP1124645 The Bill and Melinda Gates Foundation
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 Randomization done using Stata software Randomization done using software without any human intervention. Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Sannut program (CLTS Plus) Once 2 months The intervention was an add-on to standard CLTS programming consisting of two community meetings for caregivers with children under 5, plus additional messaging for community health workers when they do routine household visits. The messaging was about household sanitation conditions, toddler nutritional practices, and child health outcomes. 2279
Control Group Standard Community-Led Total Sanitation (CLTS) Once 2 months Communities were incentivized to stop openly defecating through shaming and disgust upon realization that they were ingesting each others feces. This happened in a community meeting where open defecation in the community was mapped and the associated diseases was discussed. 2157 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
At village level, villages that were part of the ongoing CLTS program and closer than 10km from the nearest health facility. At household level, caregivers of children under 5 and pregnant women in evaluation villages. Villages that were classified as open defecation free and in areas where other nutrition interventions were being rolled out. 18 Year(s) 100 Year(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 31/10/2016 Kenya Medical Research Institute
Ethics Committee Address
Street address City Postal code Country
KEMRI, P.O. Box 54840 Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Sanitation knowledge Endline, 3-4 month after completion of the intervention
Primary Outcome Latrine use (self-reported) Endline, 3-4 month after completion of the intervention
Primary Outcome Latrine structure maintenance Endline, 3-4 month after completion of the intervention
Primary Outcome Courtyard cleanliness Endline, 3-4 month after completion of the intervention
Primary Outcome Disposal of child feces (self-reported) Endline, 3-4 month after completion of the intervention
Primary Outcome Handwashing infrastructure Endline, 3-4 month after completion of the intervention
Primary Outcome Handwashing practice (self-reported) Endline, 3-4 month after completion of the intervention
Primary Outcome Child diarrhoea (self-reported) Endline, 3-4 month after completion of the intervention
Primary Outcome Nutrition knowledge Endline, 3-4 month after completion of the intervention
Primary Outcome Proper feeding practice (self-reported) Endline, 3-4 month after completion of the intervention
Primary Outcome Health facility visits Endline, 3-4 month after completion of the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kitui County Kitui county Kitui county 90200 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
The Bill and Melinda Gates Foundation P.O. Box 23350 Seattle 98102 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor IDinsight Hurlingham Park A5, Argwings Kodhek road Nairobi 00800 Kenya Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Gerishom Gimaiyo Hurlingham Park A5, Argwings Kodhek Road. Nairobi 00800 Kenya
Lilian Lehmann Hurlingham Park A5, Argwings Kodhek Road. Nairobi 00800 Kenya
Jeff McManus 785 Market St, Suite 200 San Fransisco 94103 United States of America
Shiva Singh UN Complex, United Nations Ave Nairobi 00100 Kenya
Andrew Trevett UN Complex, United Nations Ave Nairobi 00100 Kenya
Grainne Moloney UN Complex, United Nations Ave Nairobi 00100 Kenya
Ann Robins UN Complex, United Nations Ave Nairobi 00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Lilian Lehmann lilian.lehmann@idinsight.org +639777356877 Hurlingham Park A5, Argwings Kodhek Rd.
City Postal code Country Position/Affiliation
Nairobi 00800 Kenya Director - IDinsight
Role Name Email Phone Street address
Public Enquiries Gerishom Gerishom gerishom.gimaiyo@idinsight.org +254702684604 Hurlingham Park A5, Argwings Kodhek Rd.
City Postal code Country Position/Affiliation
Nairobi 00800 Kenya Senior Associate - IDinsight
Role Name Email Phone Street address
Scientific Enquiries Jeff McManus jeffery.mcmanus@idinsight.org +19419610711 785 Market St, Suite 200
City Postal code Country Position/Affiliation
San Fransisco 94103 United States of America Senior Economist - IDinsight
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information