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.: PACTR201711002699153 Date of Registration: 17/10/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The i-SPAN study for prevention/control of childhood obesity
Official scientific title The iLembe School Physical Activity and Nutrition (i-SPAN) study for the control and prevention of childhood obesity
Brief summary describing the background and objectives of the trial The health status of many communities across the globe is in a state of transition. Urbanization and other health determinants have led to reduced physical activity and unhealthy eating that have increased the risk of adverse chronic health conditions. This study aims to provide evidence of the effectiveness of school-based interventions that target diet and physical activity to address overweight and/or obesity in children and adolescents, and provide recommendations for future interventions.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) i SPAN study
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Obesity
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/02/2018
Actual trial start date 01/03/2018
Anticipated date of last follow up 31/10/2018
Actual Last follow-up date 15/11/2018
Anticipated target sample size (number of participants) 2400
Actual target sample size (number of participants) 2188
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 randomisation using a radomisation 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 i-SPAN interventions weekly two hours school-based diet and physical activity classroom and outdoor activities 1094 Active-Treatment of Control Group
Control Group i-SPAN interventions weekly two hours school-based diet and physical activity classroom and outdoor activities will not be conducted with control group but they will receive the intervention toolkit 1094 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
For children and adolescents Grades 4 and 7 (aged 9-15 years), they must be school-going learners. For all school-going learners the anthropometry measurements will be completed during the intervention phase (baseline and end of study). There will be no exclusion criteria except if the parent/primary caregiver declines or terminates participation. Children with physical disabilities will be excluded from the anthropometry as length/height measurements may be inaccurate but they will be included in the larger survey. For parent participation, if parents do not complete questionnaires and participate after two attempts made by fieldworkers, then they will be excluded from the study. 9 Year(s) 15 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
No 01/09/2017 Biomedical Research Ethics Committee (BREC)
Ethics Committee Address
Street address City Postal code Country
Research Office, Westville Campus Govan Mbeki Building University of KwaZulu-Natal Private Bag X 54001 Durban 4000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To promote healthy eating and food choices in children and adolescents to prevent/control overweight and obesity Baseline and at the end of the study
Primary Outcome To increase participation of children and adolescents in physical activity that emphasises indigenous games of South Africa to prevent/control overwight and obesity Baseline and at the end of the study
Primary Outcome To reduce the BMI in children and adolescents to prevent/control overweight and obesity Baseline and at the end of the study
Secondary Outcome To create and promote an environment for the school that facilitates the adoption of healthy lifestyles During and after completion of the study
Secondary Outcome To build capacity and development of the school staff and the stakeholders in the development, implementation, assessment and sustainability of school-based health promotion interventions During and after completion of the intervention
Secondary Outcome To disseminate the findings of the study interventions to the Departments of Health, Education, Sports and Recreation, as well as policy makers to address a wider implementation of the study in other areas in South Africa After completion of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ALDINVILLE S.P. R102 Old Main Rd, Groutville KwaDukuza 4449 South Africa
BHEKAMAFA P. 1513 D Section. Wosiyane Village Ndwedwe 4342 South Africa
DUMEZWENI J.P. Emayekeni Area,Ndwedwe-A,Verulam Ndwedwe 4342 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
National Research Foundation NRF Building South Gate CSIR Complex Meiring Naudé Road Brummeria Pretoria 0001 South Africa
South African Medical Research Council Duiker St Cape Town 7501 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Natisha Dukhi School of Nursing and Public Health, College of Health Sciences Durban 4000 South Africa University
COLLABORATORS
Name Street address City Postal code Country
N/A
Adeniyi Francis Fagbamigbe Box 4078 Ibadan 200001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Natisha Dukhi Dukhin@ukzn.ac.za +27312604499 Public Health Medicine, University of KwaZulu-Natal, Science Drive
City Postal code Country Position/Affiliation
Durban 4000 South Africa Post-Doctoral Fellow
Role Name Email Phone Street address
Public Enquiries Myra Taylor Taylor@ukzn.ac.za +27312604499 Public Health Medicine, University of KwaZulu-Natal, Science Drive
City Postal code Country Position/Affiliation
Durban 4000 South Africa Associate Professor
Role Name Email Phone Street address
Scientific Enquiries Benn Sartorius Sartorius@ukzn.ac.za +27312604459 Public Health Medicine, University of KwaZulu-Natal, Science Drive
City Postal code Country Position/Affiliation
Durban 4000 South Africa Professor and Biostatistician
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Informed Consent Form,Statistical Analysis Plan,Study Protocol
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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