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.: PACTR202604638953878 Date of Registration: 21/04/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ASIBE Healthy: Jozi Kids
Official scientific title Cities for Better Health Childhood Obesity Prevention Initiative (CBH COPI)
Brief summary describing the background and objectives of the trial More than 379 million children and adolescents live with obesity and global obesity rates among children and adolescents are rapidly increasing. In South Africa the prevalence of overweight and obesity in primary school aged children ranges between 17- 25%. Vulnerable groups are 3-5 times more likely to develop obesity and an estimated 2.3% of global disability adjusted life years (DALYs) are attributable to overweight and obesity. Previous research has shown that implementing evidence-based prevention initiatives in communities can reduce the risk of obesity in children, and even small changes in body mass index (BMI) can have a significant impact on long-term risk of critical health conditions like cardiovascular disease (CVD) and type 2 diabetes (T2D), if delivered at scale. Globally, however, prevention is systematically underfunded and there has been inadequate implementation of approaches known to be effective. As such this study aims to establish impactful, and scalable community-based interventions for the prevention of childhood obesity in disadvantaged urban communities. The intervention will comprise ofcommunity co-designed multi-level and multi-component intervention packages targeting diet and physical activity, with a focus on health equity. The objective of this project is to develop, implement, and evaluate the effectiveness of a package of prevention interventions among children aged 6-13 years of age living in Soweto, South Africa. The intervention packages are intended to promote healthy eating, physical activity, health-related quality of life, and a reduction in the rates of children living with overweight or obesity. Primary: To estimate the impact of the intervention packages on the average BMI of the target population of children at one-year and two-year follow-ups. Secondary: To estimate the impact of the intervention packages on average health-related quality of life of the target population of children at one-year and two-year follow-ups
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CBH COPI
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 01/04/2026
Actual trial start date
Anticipated date of last follow up 30/04/2028
Actual Last follow-up date
Anticipated target sample size (number of participants) 3300
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 Exercise and Nutrition Focused Program Weekly Two Years • School Nutrition Clubs: Each school would form “School Nutrition Clubs”, guided through experiential learning activities on nutrition, physical activity, the food environment, and advocacy. • Nudges and boosting: Utilise social and behaviour change tools of “nudges and boosting” to interweave nutrition education throughout interventions. These tools will be used in various ways as a means to educate, empower and encourage good nutrition and more physical activity. • Strengthening the delivery of the National School Nutrition Programme (NSNP): gaps and opportunities for improving the implementation of the NSNP will be identified in collaboration with relevant parties to strengthen the delivery of this successful programme in the schools. • Education and guidance for food handlers: education sessions will be held to strengthen the food preparation process. This will be supported by information, education and communication (IEC) materials and existing guidelines. As required, professional mentoring will be offered. • Business support to food vendors: business support will be offered to vendors in and around the schools, with a focus on improving the healthiness of the food and beverages on sale, based on existing national tuckshop guidelines, while maintaining a profitable business. • School-based physical activity program: The program will be integrated into curriculum time and is aligned with the National Curriculum Policy Statement (CAPS). Facilitators will support educators to deliver high-quality, age-appropriate physical education 1500
Control Group Oral Hygiene Program Weekly Two Years Control schools will receive a “light-touch" intervention not focused on nutrition or physical activity and may include the following: Art classes Culture focused activities Reading and library 1800 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
School: Geographic location - Schools situated within Soweto and administratively under the Johannesburg South and West District Managers of the Gauteng Department of Education (GDE) were considered. Economic quintile -South African schools are categorised as quintile 2 and quintile 3 Child: Attending a school enrolled in the study Aged 6-13 years (both 6 and 13 allowed) at the time of signed consent from a parent or legal guardian and assent from the chi School: School size - Schools with fewer than 180 enrolled learners were excluded School Type - No private or independent schools were considered. Economic Quintile - Quintile 1,4,5 Adolescent: 13 Year(s)-17 Year(s),Child: 6 Year-12 Year 6 Year(s) 13 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 10/03/2026 University of the Witwatersrand Human Research Ethics Committee Medical
Ethics Committee Address
Street address City Postal code Country
Faculty of Health Sciences, Phillip Tobias Building, Offices 301-304, 3rd Floor, Corner York Road, and 29 Princess of Wales Terrace, Parktown, 2193. Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To estimate the impact of the intervention packages on the average BMI z-score adjusted for age and sex of the target population of children at one-year and two-year follow-ups. At the end of a 24 month program
Secondary Outcome To estimate the impact of the intervention packages on average health-related quality of life, using the KIDSCREEN-10 index, of the target population of children at one-year and two-year follow-ups. At the end of a 24 month program
Secondary Outcome Exploratory: To estimate the impact of the intervention packages on behaviours related to physical activity and diet for the target population of children at one-year and two-year follow ups, and to model the long-term effects that the intervention packages might have on quality adjusted and disability-adjusted life years, and blood pressure. At the end of a 24 month program
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Moses Kotane Primary School Phase 1, Braamfischer, Roodepoort, 1724 Johannesburg South Africa
Tsietsi Mashinini Primary School Leeba St, Meadowlands Zone 7, Johannesburg, 1852 Johannesburg South Africa
Tshireletso Primary School Bakwena St, Meadowlands, Johannesburg, 1852 Johannesburg South Africa
Empumalanga Primary School 3809 Somkele St, Meadowlands East Zone 4, Meadowlands East, 1852 Johannesburg South Africa
Molemo Primary School 9961 Ntombela St, Orlando West, Soweto, 1804 Johanessburg South Africa
Mbuyisa Makhubu Primary School 7345 Mahalefele Str, Orlando West, Johannesburg, 1804 Johannesburg South Africa
Onkgopotse Tiro Primary School 10613 DULCIE SEPTEMBER ROAD, Tshepisong, Soweto, 1754 Johannesburg South Africa
Slovoville Primary School Slovoville, Soweto, 1754 Johannesburg South Africa
Lufhereng Primary School No. 1 1083 Mulembu Street, LUFHERENG, Soweto, 1863 Johannesburg South Africa
Mayibuye Primary School Doornkop, Soweto, 1874 Johannesburg South Africa
Obed Mosiane Primary School 5329 Road 1101, Thulani, Dobsonville, 1724 Johannesburg South Africa
Braamfischerville Primary School Stand 2513 Phase 2, Jackie Ncube Dr, Roodepoort, 1725 Johannesburg South Africa
Mokorotlo Primary School Molapo St, Mofolo Central, Johannesburg, 1852 Johannesburg South Africa
Emathafeni Primary School Twala St, Zondi, Johannesburg, 1868 Johannesburg South Africa
Indyebo Primary School 6524 Mooki St, Orlando East, Soweto, 1804 Johannesburg South Africa
Isu lihle Primary School 781 Khanyile St, Zola, Soweto, 1878 Johannesburg South Africa
Merafe Primary School Sekese Street, Maukana St, Johannesburg, Soweto, 1868 Johannesburg South Africa
Itekeng Primary School Phiri Street, Soweto, Johannesburg, 1809 Johannesburg South Africa
Isiseko Primary School Modise St, Jabavu, Soweto, 1809 Johannesburg South Africa
Lakeview Primary School 2214 Moeketsi St, Dlamini Ext 5, Johannesburg, 1818 Johannesburg South Africa
Megatong Primary School 2984, Mapetla, Soweto, 1818 Johannesburg South Africa
Tshilidzi Primary School 1212 Thoho Ya Ndou St, Chiawelo, Soweto, 1818 Johannesburg South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Novo Nordisk Novo Alle 1 Bagsvaerd Denmark
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Wits Health Consortium 31 Princess of Wales Terrace Johannesburg South Africa University
COLLABORATORS
Name Street address City Postal code Country
Behavioural Insights Team 58 Victoria Embankment London United Kingdom
University of Oxford Wellington Square, Oxford OX1 2JD, United Kingdom Oxford United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator David Everatt david.everatt@wits.ac.za 0834559466 Wits School of Governance, University of the Witwatersrand
City Postal code Country Position/Affiliation
Johannesburg South Africa University if Witwatersrand School of Governance
Role Name Email Phone Street address
Scientific Enquiries Shane Norris shane.norris@wits.ac.za 0829282381 26 Chris Hani Road
City Postal code Country Position/Affiliation
Soweto South Africa Wits SAMRC Developmental Pathways for Health Research Unit
Role Name Email Phone Street address
Public Enquiries Lea Castro NLZC@novonordisk.com 0825388770 90 Grayston Drive
City Postal code Country Position/Affiliation
Johannesburg South Africa Strategic Partnerships Manager and Local COPI Lead
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes According to the Novo Nordisk disclosure commitment on novonordisk-trials.com Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol According to the Novo Nordisk disclosure commitment on novonordisk-trials.com Novo Nordisk A/S supports secondary use of data from Novo Nordisk sponsored clinical studies for conducting further legitimate scientific research as set out in the joint EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing. If you are a researcher, you can request access to anonymized patient level data and study protocols from studies which have been completed after 2001, if product indications have obtained marketing authorization in both the EU and US. You can as data requestor submit a scientific research proposal to document the legitimacy of your research project and the qualifications of your research team. Access to individual study participant level data can be considered if the data can be sufficiently anonymized to protect personal identifiable information, safeguarding study participants’ privacy, if patients’ informed consent which was given in relation to their participation in the clinical study, can be respected. Novo Nordisk A/S current data sharing platform will be decommissioned by the end of 2024, and we are investigating alternative data sharing methods on high priority. More information about this will be disclosed on this website when we have news to share. If you need further information, please contact us using our mailbox irb-secretariat@novonordisk.com.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.novonordisk-trials.com/ 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
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 31/03/2026 Requested change by reviewer Child: 6 Year-12 Year Child: 6 Year-12 Year, Adolescent: 13 Year(s)-17 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 31/03/2026 Requested Change By Reviewer Experimental Group, Intervention, Weekly, Two Years , • School Nutrition Clubs: Each school would form “School Nutrition Clubs”, guided through experiential learning activities on nutrition, physical activity, the food environment, and advocacy. • Nudges and boosting: Utilise social and behaviour change tools of “nudges and boosting” to interweave nutrition education throughout interventions. These tools will be used in various ways as a means to educate, empower and encourage good nutrition and more physical activity. • Strengthening the delivery of the National School Nutrition Programme (NSNP): gaps and opportunities for improving the implementation of the NSNP will be identified in collaboration with relevant parties to strengthen the delivery of this successful programme in the schools. • Education and guidance for food handlers: education sessions will be held to strengthen the food preparation process. This will be supported by information, education and communication (IEC) materials and existing guidelines. As required, professional mentoring will be offered. • Business support to food vendors: business support will be offered to vendors in and around the schools, with a focus on improving the healthiness of the food and beverages on sale, based on existing national tuckshop guidelines, while maintaining a profitable business. • School-based physical activity program: The program will be integrated into curriculum time and is aligned with the National Curriculum Policy Statement (CAPS). Facilitators will support educators to deliver high-quality, age-appropriate physical education, 1500, Experimental Group, Exercise and Nutrition Focused Program , Weekly, Two Years , • School Nutrition Clubs: Each school would form “School Nutrition Clubs”, guided through experiential learning activities on nutrition, physical activity, the food environment, and advocacy. • Nudges and boosting: Utilise social and behaviour change tools of “nudges and boosting” to interweave nutrition education throughout interventions. These tools will be used in various ways as a means to educate, empower and encourage good nutrition and more physical activity. • Strengthening the delivery of the National School Nutrition Programme (NSNP): gaps and opportunities for improving the implementation of the NSNP will be identified in collaboration with relevant parties to strengthen the delivery of this successful programme in the schools. • Education and guidance for food handlers: education sessions will be held to strengthen the food preparation process. This will be supported by information, education and communication (IEC) materials and existing guidelines. As required, professional mentoring will be offered. • Business support to food vendors: business support will be offered to vendors in and around the schools, with a focus on improving the healthiness of the food and beverages on sale, based on existing national tuckshop guidelines, while maintaining a profitable business. • School-based physical activity program: The program will be integrated into curriculum time and is aligned with the National Curriculum Policy Statement (CAPS). Facilitators will support educators to deliver high-quality, age-appropriate physical education, 1500,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 31/03/2026 Requested change by reviewer Control Group, Control, Weekly, Two Years, Control schools will receive a “light-touch" intervention not focused on nutrition or physical activity and may include the following: Art classes Culture focused activities Reading and library , 1800, Active-Treatment of Control Group Control Group, Oral Hygiene Program, Weekly, Two Years , Control schools will receive a “light-touch" intervention not focused on nutrition or physical activity and may include the following: Art classes Culture focused activities Reading and library , 1800, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 31/03/2026 Reviewer requested change Primary Outcome, To estimate the impact of the intervention packages on the average BMI z-score adjusted for age and sex of the target population of children at one-year and two-year follow-ups., 24 Months Primary Outcome, To estimate the impact of the intervention packages on the average BMI z-score adjusted for age and sex of the target population of children at one-year and two-year follow-ups., Following a 24 month program
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 31/03/2026 Reviewer requested change Primary Outcome, To estimate the impact of the intervention packages on the average BMI z-score adjusted for age and sex of the target population of children at one-year and two-year follow-ups., Following a 24 month program Primary Outcome, To estimate the impact of the intervention packages on the average BMI z-score adjusted for age and sex of the target population of children at one-year and two-year follow-ups., At the end of a 24 month program
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 31/03/2026 Reviewer requested change Secondary Outcome, To estimate the impact of the intervention packages on average health-related quality of life, using the KIDSCREEN-10 index, of the target population of children at one-year and two-year follow-ups., 24 Months Secondary Outcome, To estimate the impact of the intervention packages on average health-related quality of life, using the KIDSCREEN-10 index, of the target population of children at one-year and two-year follow-ups., Following a 24 month program
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 31/03/2026 Reviewer requested change Secondary Outcome, To estimate the impact of the intervention packages on average health-related quality of life, using the KIDSCREEN-10 index, of the target population of children at one-year and two-year follow-ups., Following a 24 month program Secondary Outcome, To estimate the impact of the intervention packages on average health-related quality of life, using the KIDSCREEN-10 index, of the target population of children at one-year and two-year follow-ups., At the end of a 24 month program
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 31/03/2026 Reviewer requested change Secondary Outcome, Exploratory: To estimate the impact of the intervention packages on behaviours related to physical activity and diet for the target population of children at one-year and two-year follow ups, and to model the long-term effects that the intervention packages might have on quality adjusted and disability-adjusted life years, and blood pressure., 24 Months Secondary Outcome, Exploratory: To estimate the impact of the intervention packages on behaviours related to physical activity and diet for the target population of children at one-year and two-year follow ups, and to model the long-term effects that the intervention packages might have on quality adjusted and disability-adjusted life years, and blood pressure., Following a 24 month program
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 31/03/2026 Reviewer requested change Secondary Outcome, Exploratory: To estimate the impact of the intervention packages on behaviours related to physical activity and diet for the target population of children at one-year and two-year follow ups, and to model the long-term effects that the intervention packages might have on quality adjusted and disability-adjusted life years, and blood pressure., Following a 24 month program Secondary Outcome, Exploratory: To estimate the impact of the intervention packages on behaviours related to physical activity and diet for the target population of children at one-year and two-year follow ups, and to model the long-term effects that the intervention packages might have on quality adjusted and disability-adjusted life years, and blood pressure., At the end of a 24 month program
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 31/03/2026 Reviewer requested Soweto Schools, N/A, Soweto Johannesburg, , South Africa Moses Kotane Primary School, Phase 1, Braamfischer, Roodepoort, 1724, Soweto Johannesburg, , South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 31/03/2026 Reviewer requested Moses Kotane Primary School, Phase 1, Braamfischer, Roodepoort, 1724, Soweto Johannesburg, , South Africa Moses Kotane Primary School, Phase 1, Braamfischer, Roodepoort, 1724, Johannesburg, , South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 31/03/2026 Reviewer requested Tsietsi Mashinini Primary School, Leeba St, Meadowlands Zone 7, Johannesburg, 1852, Johannesburg, , South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 31/03/2026 Reviewer requested Tshireletso Primary School, Bakwena St, Meadowlands, Johannesburg, 1852, Johannesburg, , South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 31/03/2026 Reviewer requested Empumalanga Primary School, 3809 Somkele St, Meadowlands East Zone 4, Meadowlands East, 1852, Johannesburg, , South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 31/03/2026 Reviewer requested Molemo Primary School, 9961 Ntombela St, Orlando West, Soweto, 1804, Johanessburg, , South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 31/03/2026 Reviewer requested Mbuyisa Makhubu Primary School, 7345 Mahalefele Str, Orlando West, Johannesburg, 1804, Johannesburg, , South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 31/03/2026 Reviewer requested Onkgopotse Tiro Primary School, 10613 DULCIE SEPTEMBER ROAD, Tshepisong, Soweto, 1754, Johannesburg, , South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 31/03/2026 Reviewer requested Slovoville Primary School, Slovoville, Soweto, 1754, Johannesburg, , South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 31/03/2026 Reviewer requested Lufhereng Primary School No. 1, 1083 Mulembu Street, LUFHERENG, Soweto, 1863, Johannesburg, , South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 31/03/2026 Reviewer requested Mayibuye Primary School, Doornkop, Soweto, 1874, Johannesburg, , South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 31/03/2026 Reviewer requested Obed Mosiane Primary School, 5329 Road 1101, Thulani, Dobsonville, 1724, Johannesburg, , South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 31/03/2026 Reviewer requested Braamfischerville Primary School, Stand 2513 Phase 2, Jackie Ncube Dr, Roodepoort, 1725, Johannesburg, , South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 31/03/2026 Reviewer requested Mokorotlo Primary School, Molapo St, Mofolo Central, Johannesburg, 1852, Johannesburg, , South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 31/03/2026 Reviewer requested Emathafeni Primary School , Twala St, Zondi, Johannesburg, 1868, Johannesburg, , South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 31/03/2026 Reviewer requested Indyebo Primary School , 6524 Mooki St, Orlando East, Soweto, 1804, Johannesburg, , South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 31/03/2026 Reviewer requested Isu lihle Primary School , 781 Khanyile St, Zola, Soweto, 1878, Johannesburg, , South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 31/03/2026 Reviewer requested Merafe Primary School , Sekese Street, Maukana St, Johannesburg, Soweto, 1868, Johannesburg, , South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 31/03/2026 Reviewer requested Itekeng Primary School , Phiri Street, Soweto, Johannesburg, 1809, Johannesburg, , South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 31/03/2026 Reviewer requested Isiseko Primary School , Modise St, Jabavu, Soweto, 1809, Johannesburg, , South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 31/03/2026 Reviewer requested Lakeview Primary School, 2214 Moeketsi St, Dlamini Ext 5, Johannesburg, 1818, Johannesburg, , South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 31/03/2026 Reviewer requested Megatong Primary School, 2984, Mapetla, Soweto, 1818, Johannesburg, , South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 31/03/2026 Reviewer requested Tshilidzi Primary School, 1212 Thoho Ya Ndou St, Chiawelo, Soweto, 1818, Johannesburg, , South Africa