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.: PACTR202305718679999 Date of Approval: 22/05/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of dietary supplementation and high-intensity motor learning on nutritional status, body composition, linear growth and muscle strength of 5-7 years old children with moderate acute malnutrition in Jimma Town south-west, Ethiopia
Official scientific title Effect of dietary supplementation and high-intensity motor learning on nutritional status, body composition, linear growth and muscle strength of 5-7 years old children with moderate acute malnutrition in Jimma Town south-west, Ethiopia: An exploratory interventional study
Brief summary describing the background and objectives of the trial Summary Background: Malnutrition is a global public health problem in both children and adults. Acute malnutrition is one of the leading global public health concerns, including in low- and middle-income countries (LMICs). Approximately 52 million under-five children suffer from acute malnutrition worldwide of which 17 million had severe acute malnutrition (SAM) leading to 8% of global deaths each year. Death from moderate acute malnutrition (MAM) is more prevalent than severe acute malnutrition (SAM) and affects approximately 64% of all those categorized as having acute malnutrition. It is not only a public health concern but also an impediment to global poverty eradication, productivity, and economic growth. By eliminating malnutrition, it is estimated that 32% of the global disease burden would be removed. As a widespread serious problem affecting children in developing countries, progress towards tackling the different forms of malnutrition remains relatively slow. Moreover, there is limited or no documented evidence on the effect of dietary supplementation and high-intensity motor learning on linear growth, muscle strength, body composition, and nutritional status of 5-7years old children with MAM. Objective: This study aims to assess the effect of dietary supplementation using Ready to Use Supplementary Food (RUSF) and high-intensity motor learning (HiML) or their combination on linear growth, body composition, muscle strength, time to recovery, hemoglobin level, and nutritional status of 5 - 7 years of age children with MAM in Jimma town, 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 Physical activity and nutrition
Anticipated trial start date 01/03/2023
Actual trial start date 16/03/2023
Anticipated date of last follow up 21/09/2023
Actual Last follow-up date 25/10/2023
Anticipated target sample size (number of participants) 45
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 Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group RUSF Arm 1: RUSF:7sachets/per child/week (1 per day) received allocated intervention (n= 15 MAM cases) 12 or 16weeks The study is based on a targeted dietary supplementation (RUSF) and high intensity motor learning (HiML) to children aged 5-7 years who are screened for MAM. Study participants will be allocated to one of the three intervention arms: Arm 1. Ready-to-use Supplementary Food (RUSF) Children included in the study will receive supplementation RUSF in a quantity sufficient to meet their nutrient requirements for full catch-up growth (175 kcal/kg/day) for 12weeks. The required amounts will be calculated for 12 weeks. Children will be given the sachets every day in the school. high intensity motor learning (HiML) is an exercise modality that involves multiple joint movements and emphasizes general physical fitness and functional performance. This high intensity motor learning (HiML) program will be developed by consulting pediatric rehabilitation professionals and other experts in the area. After collecting baseline information, each child in the intervention group will be assigned to the RUSF group or RUSF+ high intensity motor learning (HiML) group, or the control group. The ration will be distributed on a daily or weekly basis for 12 weeks. The subjects will be served the supplements in the morning as a breakfast. 15
Experimental Group RUSF and HiML Arm 2: RUSF:7sachets/per child/week (1 per day), and HiML received allocated intervention (n= 15 MAM cases) HiML(60min) five x/weeks, 12 weeks) 12 or 16 weeks The study is based on a targeted dietary supplementation (RUSF) and high intensity motor learning (HiML) to children aged 5-7 years who are screened for MAM. Study participants will be allocated to one of the three intervention arms: Arm 2. Ready-to-use Supplementary Food (RUSF) + high intensity motor learning (HiML) Children included in the study will receive supplementation RUSF in a quantity sufficient to meet their nutrient requirements for full catch-up growth (175 kcal/kg/day) for 12weeks. The required amounts will be calculated for 12 weeks. Children will be given the sachets every day in the school. high intensity motor learning (HiML) is an exercise modality that involves multiple joint movements and emphasizes general physical fitness and functional performance. This high intensity motor learning (HiML) program will be developed by consulting pediatric rehabilitation professionals and other experts in the area. After collecting baseline information, each child in the intervention group will be assigned to the RUSF group or RUSF+ high intensity motor learning (HiML) group, or the control group. The ration will be distributed on a daily or weekly basis for 12 weeks. The subjects will be served the supplements in the morning as a breakfast. 15
Control Group Control group Arm 3: control group (MAM children receiving no intervention) (n= 15 MAM cases) 12 or 16 weeks The study is based on a targeted dietary supplementation (RUSF) and high intensity motor learning (HiML) to children aged 5-7 years who are screened for MAM. Study participants will be allocated to one of the three intervention arms: Arm 3. Control group Children included in the study will receive supplementation RUSF in a quantity sufficient to meet their nutrient requirements for full catch-up growth (175 kcal/kg/day) for 12weeks. The required amounts will be calculated for 12 weeks. Children will be given the sachets every day in the school. high intensity motor learning (HiML) is an exercise modality that involves multiple joint movements and emphasizes general physical fitness and functional performance. This high intensity motor learning (HiML) program will be developed by consulting pediatric rehabilitation professionals and other experts in the area. After collecting baseline information, each child in the intervention group will be assigned to the RUSF group or RUSF+ high intensity motor learning (HiML) group, or the control group. The ration will be distributed on a daily or weekly basis for 12 weeks. The subjects will be served the supplements in the morning as a breakfast. 15 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Boys/girls confirmed to have MAM (BMI-for-age <-3 / ≥ -3 to < -2), with no bilateral pitting edema, or other complications aged 5 to 7 years. Overt physical disability (Kyphosis, Scoliosis), limb deformity that prevents standing erect, visual/auditory problems, neuromotor difficulties, known TB, HIV/AIDS, or with suspected allergies to ingredients in the supplements, on Outpatient Therapeutic Program (OTP), MAM children who have a skin infection (edematous), plans to leave the study area in the next 6 months, and seriously ill children or preschoolers during the study period. Children with any illness or other medical complications that prevent them from safely consuming supplementary food and children already participating in other interventions, walking impairment due to orthopaedic reasons, e.g., due to previous surgery in the lower extremity region Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 5 Year(s) 7 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 10/03/2023 Jimma University Institute of health IRB
Ethics Committee Address
Street address City Postal code Country
Jimma University Pobox 378 Jimma , Oromia 378 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcomes: muscle strength, body composition (Fat-free mass (FFM) and fat mass (FM)), linear growth, and nutritional status. Secondary outcomes: hemoglobin level, time to recovery. 2 to 3
Secondary Outcome Hemoglobin level at baseline and endline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
All recruitment center is in Jimma town and out of eight schools three of them will be selected randomly Jimma Town , Southwest of Ethiopia Jimma Oromia Ethiopia
schools 1 Jiren primary school Jimma Town Jimma Oromia Ethiopia
Schools 2 Mendera primary school Jimma Town Jimma Oromia Ethiopia
Schools 3 Dilfire primary schools Jimma Town Jimma Oromia Ethiopia
School 4 Bore primary school Jimma , Town Jimma Oromia Ethiopia
School 5 Ginjo primary School Jimma , Town Jimma Oromia Ethiopia
School 6 Hibret primary school Jimma , Town Jimma Oromia Ethiopia
School 7 Seto Yido primary school Jimma , Town Jimma Oromia Ethiopia
School 8 Hirmata primary school Jimma , Town Jimma Oromia Ethiopia
For our study we will select three primary school i.e school 1 Jiren primary school school 2 Mendera primary school and school 3 Dilfire primary school. Jimma , Town Jimma Oromia Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Jimma University Institute of Health Public Health Faculty Jimma Jimma Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Jimma University Jimma Universirty Jimma Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Melese Sinaga Teshome sinmele@gmail.com +251911538218 Jimma , Ethiopia
City Postal code Country Position/Affiliation
Jimma Ethiopia Ass.Professor
Role Name Email Phone Street address
Public Enquiries Tefera Belachew Lema teferabelachew2@gmail.com +251917804072 Jimma , Ethiopia
City Postal code Country Position/Affiliation
Jimma Ethiopia Professor
Role Name Email Phone Street address
Scientific Enquiries Eugene RAMECKERS eugene.rameckers@uhasselt.be +31619221805 Hasselt University - campus Diepenbeek ,Agoralaan Gebouw A B-3590 Diepenbeek
City Postal code Country Position/Affiliation
Hasselt Belgium Professor
Role Name Email Phone Street address
Scientific Enquiries Marita GRANITZER marita.granitzer@uhasselt.be +32479389528 Hasselt University - Campus Diepenbeek Agoralaan Building A - B-3590 Diepenbeek
City Postal code Country Position/Affiliation
Hasselt Belgium Professor
Role Name Email Phone Street address
Scientific Enquiries Evi VERBECQUE evi.verbecque@uhasselt.be +32489915414 REVAL - Rehabilitation Research Center
City Postal code Country Position/Affiliation
Antwerp Belgium Professor
Role Name Email Phone Street address
Scientific Enquiries Sarah Mingels sarah.mingels@kuleuven.be +32479389528 Hasselt University - Campus Diepenbeek Agoralaan Building D - B-3590 Diepenbeek
City Postal code Country Position/Affiliation
Hasselt Belgium Professor
Role Name Email Phone Street address
Scientific Enquiries Tekelu Gemechu teklugem@yahoo.com +251917804540 Jimma , Ethiopia
City Postal code Country Position/Affiliation
Jimma Ethiopia Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Personal information de-identified data will be available on an official request to the principal investigator. Informed Consent Form Through publication till 2024/25 MAM
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