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.: PACTR202204556803667 Date of Registration: 01/04/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ending green hunger and under-five malnutrition through government-led health development army (HDA): A study protocol for cluster-randomized community effectiveness hybrid type III trial (RCT)
Official scientific title Ending green hunger and under-five malnutrition through government-led health development army (HDA): A study protocol for cluster-randomized community effectiveness hybrid type III trial (RCT)
Brief summary describing the background and objectives of the trial Introduction: Malnutrition, in all its forms, is a major public health problem among under-five children in low-income settings, including Ethiopia. Despite relentless efforts, the problem has continued to be a major public health concern. On the other hand, there has been insufficient effort to fully utilize existing community structures, such as the Health Development Army (HDA), to address the problem. Hence, the present implementation study aims to test and validate the effectiveness of specially trained HDAs, in the prevention, and referral of acutely malnourished children in Gedeo, southern Ethiopia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 12/10/2022
Actual trial start date
Anticipated date of last follow up 20/09/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 600
Actual target sample size (number of participants)
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
Parallel: different groups receive different interventions at same time during study 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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group RCT 18 Months The C-NUSVIC training mainly focuses on key issues such as agriculture for nutrition, prevention of green hanger (acute malnutrition), and referral of moderate acute malnutrition (MAM) and severe acute malnutrition (SAM) without complication, to a nearby health facility. The training shall also include follow-up of children on out-reach treatment (OTP). 300
Control Group Non intensive intervention 18 months The control group will not receive intervention 300 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All under five children-mothers/caregivers dyads. All under-five children-who have no mother.caregiver. Preschool Child: 2 Year-5 Year 6 Month(s) 5 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 28/03/2022 IRB
Ethics Committee Address
Street address City Postal code Country
Dilla Dilla 419 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Food security At the end of intervention
Secondary Outcome Wasting At the end of intervention
Secondary Outcome Stunting at the end of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Gedeo Zone Dilla Dilla Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Dilla University Dilla Dilla Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dilla University Dilla Dilla Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Temesgen Muche Ewunie temesgenm@du.edu.et +251932857495 Dilla
City Postal code Country Position/Affiliation
Dilla Ethiopia Researcher
Role Name Email Phone Street address
Scientific Enquiries Tadesse Alemu Zerfu tadalzerfu@gmail.com +251911062646 Dilla
City Postal code Country Position/Affiliation
Dilla Ethiopia Researcher
Role Name Email Phone Street address
Public Enquiries Zerihun Figa zerihunfiga2022@gmail.com +25116799597 Dilla
City Postal code Country Position/Affiliation
dilla Ethiopia Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will sharee data as per ethical protocol. Informed Consent Form At the end of the study. By publishing the result via a peer-reviewed journal.
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