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.: PACTR201902548129842 Date of Approval: 11/02/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECTIVENESS OF NUTRITION EDUCATION ON GLYCAEMIC CONTROL IN PEDIATRIC TYPE 1 DIABETES MELLITUS PATIENTS IN UGANDA
Official scientific title EFFECTIVENESS OF NUTRITION EDUCATION ON GLYCAEMIC CONTROL IN PEDIATRIC TYPE 1 DIABETES MELLITUS PATIENTS IN UGANDA
Brief summary describing the background and objectives of the trial Background of the study: Studies have indicated that there are inadequate dietary management practices among type 1 diabetics (T1D) which often results in preventable complications, disability and premature deaths, and yet strict glycaemic control can reduce the long-term complications of T1D.Furthermore, parental caregiving has also been shown to have an impact on glycaemic control and yet often a gap exists between recommended care and provided care resulting in failure of T1D children to meet treatment targets. Thus, the need to perform ongoing nutrition knowledge and dietary assessments of T1D children and their caregivers. In Uganda, no study has been done to find out if nutrition education has an effect on glycaemic control, nutrition knowledge and dietary management practices of caregivers and children with T1DM. Therefore, the purpose of this study is to determine the effect of nutrition education on glycaemic control in paediatric type 1 diabetes mellitus patients in Uganda. The objectives of the study are: 1. To assess the level of knowledge of nutrition management of T1DM among caregivers of T1D children (3-12 years) at selected T1DM clinics in Uganda. 2. To determine the dietary intake and adequacy of T1D children (3-12 years) at selected T1DM clinics in Uganda. 3. To develop a nutrition education training module for caregivers and T1D children (3-12 years) at selected T1DM clinics in Uganda. 4. To determine the effectiveness of nutrition education on HbAlc levels, knowledge of nutrition management of T1DM and dietary practices among caregivers and T1D children (3-12 years) at selected T1DM clinics in Uganda.
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 04/03/2019
Actual trial start date
Anticipated date of last follow up 02/09/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status 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 Nutrition education sessions The intervention group will receive one hour nutrition education sessions based on the reviewed nutrition education module once a week. 3 months The participants in the control group will continue to receive the routine medical care and nutrition services including nutrition education with the current diabetes education curriculum. The intervention group will also receive routine medical care and nutrition services; however, they will also attend group nutrition education sessions. Each session will lasting 60 minutes and will be conducted once a week for a period of 3 months. An experienced dietician, diabetes educator, or diabetes nurse specialist will conduct the nutrition education sessions using food demonstrations and audio-visual aids based on the reviewed nutrition education module. In addition, they will receive nutrition education materials (posters and brochures) and other instructional material such as stories, rhymes and games. Individual follow up sessions will be conducted for those individuals that may need further or any clarification on any component/topic of the training. The nutrition education sessions will be categorized into two age groups 3-6 years and 7-12 years due to the wide age range of the respondents (3-12 years), their different nutritional needs and to ensure the sessions are adaptable and appropriate to the age and maturity of the children as well as for their caregivers. 50
Control Group None None 3 months The participants in the control group will continue to receive the routine medical care and nutrition services including nutrition education with the current diabetes education curriculum. 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Mothers/caregivers to/and children diagnosed with type 1 diabetes aged between 3-12 years. The patients should have attended the diabetic clinic for a minimum of six months. In addition, the caregivers should have consented and the children assented to taking part in the study. T1D children with acute infections such as urinary tract infections, skin infections, respiratory infections and chronic complications such as diabetic retinopathy, nephropathy and diabetic neuropathy. T1D children who attend boarding school. Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 3 Year(s) 12 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 04/02/2019 St. Francis Hospital Nsambya
Ethics Committee Address
Street address City Postal code Country
Nsambya Hill Kampala 7146 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome HbA1c level 0, 3 and 6 months
Secondary Outcome Dietary practices 0, 3 and 6 months
Secondary Outcome Caregiver’s knowledge on nutritional management of T1DM 0, 3 and 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
St. Francis Hospital Nsambya Hill Kampala Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
KYAMBOGO UNIVERSITY Kyambogo Hill Campus Kampala Uganda
KYAMBOGO UNIVERSITY Kyambogo Hill Campus Kampala Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kyambogo University Kyambogo Hill Campus Kampala Uganda University
COLLABORATORS
Name Street address City Postal code Country
Prof. Judith Kimiywe Kenya Drive, Nairobi City, Nairobi 43844001 Kenya
Dr. Munga Judith Kenya Drive, Nairobi City, Nairobi 43844001 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nicholas Ndahura bndahura@kyu.ac.ug 256772636271 Plot 499 Kyaliwajjala
City Postal code Country Position/Affiliation
Kampala 27754 Uganda Principal investigator
Role Name Email Phone Street address
Scientific Enquiries Judith Munga munga.judith@ku.ac.ke 254722974465 Nairobi
City Postal code Country Position/Affiliation
Nairobi 43844001 Kenya First Supervisor
Role Name Email Phone Street address
Public Enquiries Judith Kimywe kimiywe.judith@ku.ac +254722915459 Nairobi
City Postal code Country Position/Affiliation
Nairobi 43844001 Kenya Second Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All data and measurements collected from each research participant in the trial. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 6 months after the end of the trial. Journals and researchers that may want to perform further data anaysis
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