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.: PACTR201905790643955 Date of Approval: 16/05/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of enhanced nutrition education of mothers on post-hospital discharge outcomes of children with severe acute malnutrition: a randomized controlled trial
Official scientific title Effect of enhanced nutrition education of mothers on post-hospital discharge outcomes of children with severe acute malnutrition: a randomized controlled trial
Brief summary describing the background and objectives of the trial Severe acute malnutrition (SAM) is a leading cause of child mortality in developing countries. High risk of mortality continues post-hospital discharge for children with SAM due to slow nutritional recovery which has been attributed in studies to sharing of Ready-to-Use-Therapeutic foods with other children at home, inconsistent RUTF supply and caregivers selling RUTF to supplement family income. Empowering caregivers to provide locally available and affordable high nutrient family foods to these children in addition to RUTF through enhanced nutrition education would improve post-discharge outcomes.This study aims to enhance nutrition education of caregivers on affordable high nutrient foods through post-discharge video demonstrations and short telephone text messages. Primary objective:To assess the effect of enhanced nutrition education regarding affordable local nutrient dense foods, using food demonstrations and telephone text messages compared to routine nutrition education, on mean dietary diversity scores of severely malnourished children aged 6-59 months discharged from a level four hospital in Nairobi at 1, 6 and 12 weeks post discharge. Secondary objectives: 1. To compare rates of weight gain, in g/kg/day, of children in the 3 study arms at 1, 6 and 12 weeks post discharge. 2. To determine caregivers’ knowledge on local nutrient dense foods across the 3 study arms at 1, 6 and 12 weeks after discharge. 3. To determine factors that affect adherence to prescribed nutrition therapy by caregivers and to determine caregiver beliefs and perceptions on RUTF and local nutrient as reported through focused group discussions
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 03/05/2019
Actual trial start date 20/05/2019
Anticipated date of last follow up 30/04/2021
Actual Last follow-up date 22/05/2021
Anticipated target sample size (number of participants) 213
Actual target sample size (number of participants)
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard of care Face to face nutrition education weekly 12 weeks Face to face counseling on locally available and affordable high nutrient family foods by nutritionist at the out-patient therapeutic center 71 Dose Comparison
Experimental Group video demonstration on local high nutrient family foods in addition to standard of care 3 times At discharge, 1 and 6 weeks post-discharge 20 minute educational video on locally available and affordable high nutrient family foods to be watched by mothers 71
Experimental Group Video demonstration and telephone text messages in addition to SOC Video demonstrations at discharge, 1 and 6 weeks post-discharge Telephone text messages weekly 3 times for video demonstrations Telephone text messages for 12 weeks Mothers will watch 20 minute educational video demonstration on locally available high nutrient family foods 3 times post-discharge and receive weekly short telephone text messages on appropriate local high nutrient foods to provide to their children in addition to receiving SOC face to face weekly nutrition education on these foods from the nutritionists at the out-patient therapeutic center. 71
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All children admitted at Mbagathi County Hospital paediatric ward or directly presenting to the outpatient nutrition clinic at Mbagathi hospital with: • age between 6 and 59 months • diagnosis of severe acute malnutrition based on either WHZ score of < 3, and/or MUAC < 115mm and/or with nutritional oedema. • informed consent by guardian/parent. • Presence of severe co-morbidity or major organ disease which itself causes growth impairment (e.g. congenital heart disease, cerebral palsy, malignancies or end organ failure e.g. liver failure). • Children who will not have a caregiver present during the in-patient period. • Children whose caregivers do not have access to a mobile phone. • Children who do not plan to reside within Nairobi for at least 12 weeks after discharge from the hospital. Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 6 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 13/06/2018 Kenyatta National Hospital University of Nairobi Ethics and Research Committee
Ethics Committee Address
Street address City Postal code Country
College of Health Sciences Kenyatta Hospital off Ngong Road Nairobi 00202 Kenya
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 13/06/2018 Kenyatta National Hospital University of Nairobi Ethics and Research Committee
Ethics Committee Address
Street address City Postal code Country
Hospital Road, Upper Hill, Nairobi Nairobi 00202 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • Mean dietary diversity scores (DDS) of children in the 3 study arms based on the 7 day dietary history at 1, 6 and 12 weeks post discharge. 1, 6 and 12 weeks post-discharge.
Secondary Outcome • Mean rates of weight gain, in g/kg/day, of children in the study arms measured at 1, 6 and 12 weeks post discharge. 1, 6 and 12 weeks post-discharge.
Secondary Outcome • Proportions of caregivers with adequate knowledge on local nutrient dense foods at 1, 6 and 12 weeks after discharge. - Adequate knowledge will be defined by caregivers providing 4 or 5 correct answers to 5 knowledge questions on local foods. 1, 6 and 12 weeks post-discharge
Secondary Outcome • Qualitative data on caregivers’ perceptions and beliefs regarding RUTF and local nutrient dense foods, as obtained from focused group discussions (FGDs) with caregivers of children with SAM, as well as facilitators and barriers to adherence to prescribed nutrition therapy that will be summarized and reported based on emerging themes. Emerging themes were used to refine messages within the nutrition educational video and telephone text messages.Data from in-depth interviews with health care workers on their experiences with adherence of caregivers to prescribed nutrition therapy will also be summarized and reported based on emerging themes. FGDs and IDIs were already been conducted in the initial qualitative phase of the study between November and December 2018.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mbagathi County Hospital Golf Course Nairobi 00202 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Partnership in Health Research and Training Grant University of Nairobi College of Health Sciences University of Nairobi of Ngong Road Nairobi 00202 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Partnership in Health Research Training Program College of Health Sciences, University of Nairobi, off Ngong Road Nairobi 00202 Kenya University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Beatrice Mutai mutaibc@gmail.com 254708552909 Department of Paediatrics, College of Health Sciences, University of Nairobi off Ngong Road
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Lecturer PhD candidate
Role Name Email Phone Street address
Public Enquiries Beatrice Mutai mutaibc@gmail.com 254708552909 Department of Paediatrics, College of Health Sciences, University of Nairobi, off Ngong Road
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Lecturer PhD candidate
Role Name Email Phone Street address
Scientific Enquiries Beatrice Mutai mutaibc@gmail.com 254708552909 Department of Paediatrics, College of Health Sciences, University of Nairobi, off Ngong Road
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Lecturer PhD candidate
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data obtained during this trial will be available after deidentification to any interested researchers and other stakeholders who may wish to use the data. Anonymized data may be used for proposal development and individual participant meta-analysis.Future research using data from this study must be approved by a local or ethical national committee to ensure the rights of participants are protected. Study Protocol Starting 3 months after publication. No end date. Data will be available at the University of Nairobi repository (at http://erepository.uonbi.ac.ke/) and will be governed by the University of Nairobi data governance policy. De-identified individual data will be available upon request to, and approval by the University of Nairobi-Kenyatta National Hospital Ethics and Research Committee.
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