Long-term effects of a lifestyle intervention on the health of children and teachers at cardiovascular risk in schools of disadvantaged communities in South Africa

ISRCTN	ISRCTN15648510
DOI	https://doi.org/10.1186/ISRCTN15648510
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Swiss National Science Foundation (SNF) No. 320030_192651
Sponsor	Swiss National Science Foundation
Funder	Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung

Submission date: 15/04/2020
Registration date: 17/04/2020
Last edited: 03/04/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
The burden of non-communicable diseases (NCDs) is rapidly increasing, especially in low- and middle-income countries (LMICs), and has been recognized as one of the biggest public health challenges of our era. While physical activity plays an important part in the prevention of NCDs in adulthood, low levels have been shown in South African youths. Children in disadvantaged communities are at particular risk of compromised health and underdevelopment. Promoting healthy lifestyles through health interventions in educational settings has proven effective at reducing the risk for NCDs. Furthermore, teachers’ own health in these communities is also poor and their collaboration as role models is essential for a successful implementation of such lifestyle interventions. In this context, a concerted community-health programme called KaziBantu was designed to enhance literacy and health of both children (KaziKidz) and teachers (KaziHealth) and was implemented in schools of marginalized communities in Port Elizabeth. Preliminary results are positive regarding the intervention but also showed that some children and teachers were at risk of developing non-communicable diseases. At the same time, discontinuation of these programmes after the end of funding is high. Therefore, this study will follow-up the KaziBantu intervention in these schools to assess its sustained implementation and the achievement of health effects under real-world conditions. The first aim of this study is to first examine long-term improvement and preservation of health effects on metabolic risk factors for NCDs in at-risk children and teachers. The second aim is to evaluate long-term feasibility, acceptance, adoption, implementation, maintenance and dissemination of the both KaziKidz and KaziHealth interventions at an individual, community, organizational and institutional level in Port Elizabeth. The third aim is to explore correlations between health effects, health behaviours and adoption and implementation level.

Who can participate?
Children in 5th – 7th grades aged 9 to 14 and teachers aged 21 to 65 from the 8 schools that participated in the KaziBantu study and who were identified for having risk factors for cardiometabolic disease (e.g. obesity, high blood pressure, diabetes)

What does the study involve?
Children and teachers will be followed-up over a 2-year period, during which measurements of health status and disease history, blood tests and body composition, physical activity and nutrition will be assessed at two different time points. Teachers and parents of the children participating in the study, school principals from the eight participating schools and authorities from the Education department will be interviewed at two different time points in order to evaluate the feasibility, acceptance, implementation and maintenance of both KaziKidz and KaziHealth interventions.

What are the possible benefits and risks of participating?
Children will be assessed physically (by a professional school nurse) and clinically in terms of cardiovascular health risks and evidence of malnutrition (by qualified biokineticists) twice during the two-year period. These children would have the benefit of having their parents alerted to any red flag(s) identified during the assessment and they will be encouraged to take their child to the nearest clinic for a medical examination. They will also receive a referral letter providing details of the identified issue of concern. The child participants will also have the continued benefit of exposure to a school-based health promotion programme that their teachers were trained to implement and are hopefully successfully implementing on their own. Teachers will benefit as they will receive two free health assessments and a personalised health profile based on internationally established clinical cut-offs over the two-year period of the study. Additionally, the teachers will have the opportunity to participate in an online course on self-assessment of personal health to educate themselves on health and wellness knowledge. Furthermore, teachers presenting with severe chronic diseases (e.g., type 2 diabetes, obesity, high blood pressure) will receive a referral letter that they could present to their medical doctor, or a nearby health clinic. However, the cost of the latter consultations will be for their own account. Most measurements are non-invasive without specific risks involved. Blood lipids, haemoglobin and blood glucose levels are assessed with a finger prick blood test. The capillary blood sampling method is minimally invasive and, therefore, only involves minimal risks.

Where is the study run from?
1. University of Basel (Switzerland)
2. Nelson Mandela University (South Africa)
3. Swiss Tropical and Public Health Institute (Switzerland)

When is the study starting and how long is it expected to run for?
April 2020 to November 2021

Who is funding the study?
Swiss National Science Foundation (SNF) (Switzerland)

Who is the main contact?
Ms Patricia Arnaiz
patricia.arnaiz@unibas.ch

Contact information

Ms Patricia Arnaiz
Scientific

Department of Sport, Exercise and Health (DSBG)
University of Basel
Birsstrasse 320B
Basel
4052
Switzerland

ORCID ID	0000-0001-5626-3510
Phone	+41 (0)61 207 47 80
Email	patricia.arnaiz@unibas.ch

Prof Uwe Pühse
Scientific

Department of Sport, Exercise and Health (DSBG)
University of Basel
Birsstrasse 320B
Basel
4052
Switzerland

ORCID ID	0000-0003-1228-316X
Phone	+41 (0)61 207 47 84
Email	uwe.puehse@unibas.ch

Study information

Primary study design	Observational
Study design	Observational longitudinal cohort study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	Sustainability of a school-based health promotion intervention in children and teachers at risk for non-communicable diseases in marginalised communities in Port Elizabeth, South Africa
Study objectives	The study aims at following-up an established school-based health promotion intervention in order to strengthen the evidence for its effectiveness in promoting long-lasting positive lifestyle changes that ultimately seek to improve cardiovascular risk factors such as obesity, hypertension, dyslipidemia and hyperglycemia among children and teachers in selected schools of marginalised areas of Port Elizabeth, South Africa.
Ethics approval(s)	1. Approved 21/07/2020, human research ethics committee (REC-H) from the Nelson Mandela University (PO Box 77000, Nelson Mandela University, Port Elizabeth, 6031, South Africa; +27 (0) 41 504 1111; info@mandela.ac.za), ref: H20-HEA-HMS-001 2. Approved 12/05/2020, Swiss ethics committee (Ethikkommission Nordwest- und Zentralschweiz, EKNZ, Hebelstrasse 53, 4056 Basel, Switzerland; +41 (0)61 268 13 50; eknz@bs.ch), ref: Req-2020-00430 3. Approved 07/12/2020, Eastern Cape Department of Education (Private Bag X0032, 5605 Bhisho, South Africa; +27 (0)40 608 4200/8; viwe.mkona@ecdoe.gov.za)
Health condition(s) or problem(s) studied	Non-communicable diseases: obesity, hypertension, diabetes, dyslipidemia
Intervention	Current interventions as of 10/03/2021: A cohort of identified at-risk children and at-risk teachers from 8 quintile 3 primary schools in Port Elizabeth, South Africa, will be followed-up during a 2-year period. Assessments of health outcomes and behaviours of both children and teachers will be collected at two time points. Community feasibility and acceptance, as well as organizational and institutional implementation and dissemination levels, will also be enquired. A comprehensive evaluation of these parameters will follow the RE-AIM framework and its proposed dimensions – (i) Reach, (ii) Efficacy, (iii) Adoption, (iv) Implementation and (v) Maintenance. _____ Previous interventions: A cohort of identified at-risk children and at-risk teachers from 8 quintile 3 primary schools in Port Elizabeth, South Africa, will be followed-up during a 2-year period. Assessments of health outcomes and behaviours of both children and teachers will be collected at two time points. Community feasibility and acceptance, as well as organizational and institutional implementation and dissemination levels, will also be enquired at two time points. A comprehensive evaluation of these parameters will follow the RE-AIM framework and its proposed dimensions – (i) Reach, (ii) Efficacy, (iii) Adoption, (iv) Implementation and (v) Maintenance.
Intervention type	Behavioural
Primary outcome measure(s)	Current primary outcome measure as of 10/03/2021: Assessed 1 and 2 years post KaziBantu intervention: 1. Body weight, assessed using a digital weighing scale 2. Body height, assessed using a stadiometer 3. Body mass index, calculated as weight (kg)/height (m)2 4. Waist and hip circumference, assess using a tape 5. Body fat percentage, assessed using bioelectrical impedance analysis (BIA) 6. Self-reported health status, assessed by questionnaire 7. Blood pressure (systolic and diastolic), assessed using oscillometry with a digital blood pressure monitor 8. Blood lipids (TC, HDL-C, LDL-C, TG, Non-HDL, C-HDL ratio), measured using the Alere Afinion AS100 analyser 9. Blood glucose (HbA1c), measured using the Alere Afinion AS100 analyser 10. Haemoglobin concentration, assessed using the HemoCue Hb 301 system 11. Objectively measured physical activity, assessed using an ActiGraph accelerometer 12. Self-reported physical activity, assessed via the Health-Behaviour of School-Aged Children (HBSC) questionnaire 13. Self-reported diet, assessed via the 24-hour recall questionnaire 14. General health assessment, assessed for teachers via online seminar 15. Implementation status, assessed via questionnaire 16. Feasibility and acceptability, assessed via semi-structured interviews and focus group discussions _____ Previous primary outcome measure: Assessed 1 and 2 years post KaziBantu intervention: 1. Body weight, assessed using a digital weighing scale 2. Body height, assessed using a stadiometer 3. Body mass index, calculated as weight (kg)/height (m)2 4. Waist and hip circumference, assess using a tape 5. Body fat percentage, assessed using bioelectrical impedance analysis (BIA) 6. Physical examination, assessed face-to-face by a professional nurse 7. Self-reported health status, assessed by questionnaire 8. Blood pressure (systolic and diastolic), assessed using oscillometry with a digital blood pressure monitor 9. Blood lipids (TC, HDL-C, LDL-C, TG, Non-HDL, C-HDL ratio), measured using the Alere Afinion AS100 analyser 10. Blood glucose (HbA1c), measured using the Alere Afinion AS100 analyser 11. Haemoglobin concentration, assessed using the HemoCue Hb 301 system 12. Objectively measured physical activity, assessed using an ActiGraph accelerometer 13. Self-reported physical activity, assessed via the Health-Behaviour of School-Aged Children (HBSC) questionnaire 14. Self-reported diet, assessed via the 24-hour recall questionnaire 15. General health assessment, assessed for teachers via online seminar 16. Implementation status, assessed via semi-structured interviews 17. Feasibility and acceptability, assessed via focus group discussions once in the fall of 2021
Key secondary outcome measure(s)	The following control variables will be assessed via questionnaire 1 and 2 years post KaziBantu intervention: 1. Age 2. Sex 3. Socioeconomic status 4. Ethnicity 5. Home language 6. School 7. Grade
Completion date	30/11/2021

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	10 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	450
Total final enrolment	459
Key inclusion criteria	Current inclusion criteria as of 17/12/2020: 1. Children and teachers from the KaziBantu study population 2. Children aged approximately 10–13 years old (4th to 7th grade) 3. Teachers aged approximately 21–65 years old 4. Children identified for being at high-risk for non-communicable diseases defined as presenting at least: 4.1. Pre- or hypertension 4.2. Pre- or diabetes 4.3. Borderline or hypercholesterolemia 4.4. Overweight or obesity 5. Written informed consent by parent/guardian for children and by teachers Previous inclusion criteria: 1. Children and teachers from the KaziBantu study population 2. Children aged approximately 10–13 years old (4th to 7th grade) 3. Teachers aged approximately 21–65 years old 4. Children and teachers identified for being at high-risk for non-communicable diseases defined as presenting at least: 4.1. Pre- or hypertension 4.2. Pre- or diabetes 4.3. Borderline or hypercholesterolemia 4.4. Overweight or obesity 5. Written informed consent by parent/guardian for children and by teachers
Key exclusion criteria	1. Participation in another clinical trial 2. Lack of written informed consent
Date of first enrolment	15/02/2021
Date of final enrolment	15/03/2021

Locations

Countries of recruitment

South Africa

Study participating centre

Nelson Mandela University

PO Box 77000
Port Elizabeth
6031
South Africa

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in publicly available repository
IPD sharing plan	Current individual participant data (IPD) sharing statement as of 17/11/2021: The individual de-identified participant data generated during and/or analysed during the current study will be stored in the publically available repository https://zenodo.org. Consent from participants was obtained, by what access criteria the data will be shared including with whom, for what types of analyses, and by what mechanism. Data is composed of a range of quantitative and qualitative data including: anthropometric (body weight, height, waist and hip circumferences), clinical (blood pressure, blood lipid profile, HbA1c), physical activity (sports participations, type and amount of physical activity), diet behaviour (type and amount of food), intervention feasibility, acceptance and implementation. Data will become available 36 months after the end of the study for at least 10 years. Previous individual participant data (IPD) sharing statement: All participant level data will be stored in Excel and Pdf form in the publicly accessible Zenodo Data Repository (https://zenodo.org), which represents a non-profit storage and sharing solution for data compliant with the funding agency requirements (SNF FAIR Data Principles). 300 datasets will be collected at two different time points with an estimated volume of 100 GB. All participants - or children guardians - will sign a consent form submitted to and approved by the responsible ethics committee. The consent forms will authorize future sharing and usage of the data. Anonymity of the participants is guaranteed, as the researchers will not deposit raw files in order not to compromise this guarantee. Instead, anonymized transcripts of data files will be deposited. All identifying information will be kept in a locked filing cabinet and not stored with electronic files.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		12/05/2023	25/05/2023	Yes	No
Protocol article	protocol	05/10/2021	21/10/2021	Yes	No
Other publications	Qualitative descriptive study	01/04/2024	03/04/2024	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

03/04/2024: Publication reference added.
25/03/2023: Publication reference added.
16/03/2023: The intention to publish date was changed from 30/03/2023 to 30/09/2023.
13/12/2022: The intention to publish date was changed from 01/12/2022 to 30/03/2023.
17/11/2021: The following changes have been made:
1. The individual participant data (IPD) sharing statement has been updated.
2. The total final enrolment number has been added.
21/10/2021: The following changes have been made:
1. Publication reference added.
2. The overall trial end date has been changed from 01/04/2023 to 30/11/2021 and the plain English summary has been updated to reflect this change.
3. The intention to publish date has been changed from 01/10/2020 to 01/12/2022.
10/03/2021: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/06/2020 to 15/02/2021.
2. The recruitment end date was changed from 01/04/2021 to 15/03/2021.
3. The interventions were changed.
4. The primary outcome measures were changed.
5. The target number of participants was changed from 300 children and 100 teachers to 300 children and 150 teachers.
17/12/2020: The following changes were made to the trial record:
1. Ethics approval details added.
2. The target number of participants was changed from 'Approximately 200 children and 50 teachers' to '300 children and 100 teachers'.
27/07/2020: Due to current public health guidance, recruitment for this study has been paused. Ethics approval details added.
17/04/2020: Trial's existence confirmed by Swiss National Science Foundation.