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.: PACTR202112690909124 Date of Approval: 20/12/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Assessing Malnutrition and Associated Determinants Among Under-five Indigenous Mbororo Children in Two Health Districts of the West Region of Cameroon
Official scientific title Assessing Malnutrition and Associated Determinants Among Under-five Indigenous Mbororo Children in Two Health Districts of the West Region of Cameroon. Nutrition, Water, Sanitation and Hygiene Education (NU-WASHE)
Brief summary describing the background and objectives of the trial Undernutrition accounts for about 45% of under-five mortality worldwide, representing a significant public health and development challenge. Children belonging to socially marginalized ethnic minority populations including indigenous peoples, are particularly at risk of undernutrition. Inadequate diets and childhood infectious diseases driven by poor child feeding and hygiene practices are among important causes of child undernutrition. This cluster-randomized control trial aims at assessing the impact of a targeted and context-specific community-based nutrition education intervention (Nu-WASH) on caregivers’ child feeding practices, and the nutritional status of children 3-59 months in Mbororo communities of two health districts of the West Region of Cameroon. The primary objective of this trial will be to investigate the effectiveness of NU-WASH in improving caregivers’ perception (knowledge, attitude and practice) regarding infant and child feeding among Mbororo communities in Galim and Foumban health districts of the West Region of Cameroon. The secondary objective is to evaluate the effectiveness of Nu-WASH in improving undernutrition status of Mbororo children under (3 – 59 months) in the Galim and Foumban health districts of the West Region. In summary, the trial will estimate the extent to which NU-WASH impacts on caregivers’ perception regarding child feeding practices, and child nutritional status in the experimental group, compared with child-caregiver pairs in the control group without the intervention.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) NUWASHE
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 31/12/2019
Actual trial start date 07/01/2020
Anticipated date of last follow up 07/06/2020
Actual Last follow-up date 30/06/2020
Anticipated target sample size (number of participants) 262
Actual target sample size (number of participants) 262
Recruitment status Not yet recruiting
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group NUWASHE Twice (each lasting 2 hours) that is every 2 weeks per month 6 months Education via Formation of Caregiver Peer groups (CPG), Selection and Training of female Mbororo Community Nutrition Volunteers (CNV), 12 Group sessions to CPG, Demonstrations, flyers and posters and Post-session counseling by CNV 131
Control Group No NUWAHSE NO 6 months No NUWASHE 131 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Galim and Foumban health districts; have at least a male and female Mbororo child 3-59 months with a female caregiver 12 years and above; Child classified as undernourished (stunted, underweight, wasted or anaemic) at baseline; Reside status of at least 6 months with no intention to leave before the next 6 months; caregivers with inadequate child feeding and WASH perception; and Provide written or verbal consent and assent for their children to participate in the trial. Non Mbororo and urban households in Galim and Foumban health districts; child-caregiver pairs who will not participate at baseline evaluation; Children not malnourished at base line; child-caregiver pairs who will participate at baseline but decline to take part in the intervention study or become seriously ill to participate. Infant: 0 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 3 Month(s) 59 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 20/09/2019 Faculty of Health Sciences Institutional Review Board University of Buea
Ethics Committee Address
Street address City Postal code Country
Molyko Buea 0237 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Improved Caregivers’ Knowledge, Attitude and practice regarding complementary feeding After 3 and 6 months
Secondary Outcome Child morbidity and growth outcomes After 3 and 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
FOUMBAN District Health service in Noun Division Foumban Health District service Foumban 0237 Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
Manjong Florence Titu Molyko Buea Cameroon
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Florence Titu Manjong Molyko Buea 0237 Cameroon Individual
COLLABORATORS
Name Street address City Postal code Country
Wirsiy Frankline Sevidzem Muea Buea 0237 Cameroon
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Florence Titu Manjong manjongflorence@gmail.com +237675708688 Molyko
City Postal code Country Position/Affiliation
Buea 0237 Cameroon Ph.D. Candidate in Public Health UNIVERSITY OF BUEA
Role Name Email Phone Street address
Public Enquiries Nashipu Thalut nashiputhalu@yahoo.com +237651162752 Mile 2 Nkwen
City Postal code Country Position/Affiliation
Bamenda 0237 Cameroon Director of Textford Institute Research Bamenda
Role Name Email Phone Street address
Scientific Enquiries Dickson Shey Nsagha dsnsagha@gmail.com +237677499429 Molyko
City Postal code Country Position/Affiliation
Buea 0237 Cameroon Associate Professor of Epidemiology
Role Name Email Phone Street address
Scientific Enquiries Thomas Obinchemti Egbe toegbe@gmail.com +237662407135 Molyko
City Postal code Country Position/Affiliation
Buea 0237 Cameroon Associate Professor Obstetrics and Gynecology
Role Name Email Phone Street address
Scientific Enquiries Vincent Siysi Verla verlaanaesthesia@yahoo.com +237677620388 Molyko
City Postal code Country Position/Affiliation
Buea 0237 Cameroon Senior Lecturer of Anesthesiologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trail, after de-identification including the underlying results that will be obtained will be made available immediately following publication for anyone who wishes to access the data (ON REQUEST) Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication (no end date) To gain access, data requestors will need to sign a data access agreement
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information