Co-creating School Community Intervention Program on Physical Activity to Increase Health Equity in Children and Adolescents
Conditions: Obese Adolescents, Mental Health
Sponsor: Sandra Andrusaityte

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BIOMEDICAL RESEARCH PROTOCOL 
 
1. Title of the Biomedical Research  
Co-creating school community intervention program on physical activity to increase health equity 
in children and adolescents (Connection). 
Protocol No: 1 
Version: 1 
Date: 2024-11-20 
2. Hypothesis of the Biomedical Research 
Community-implemented social and physical environmental interventions promoting higher 
physical activity will have a positive effect on the health of children and adolescents living in 
disadvantaged social and economic conditions and will contribute to improving health equity in 
this group. 
3. Objective of the Biomedical Research 
The Connection project aims to develop, implement, and evaluate co-created community-based 
social and physical environmental interventions that promote healthier eating and increased 
physical activity among children and adolescents living in disadvantaged social and economic 
conditions, with the main goal of improving health equity. 
4. Tasks of the Biomedical Research 
The tasks of the Connection study are: 
1. Collect data on residential air pollution (PM2.5, PM10, and NO2) and determine its 
associations with children's physical health. 
2. Gather information on children's physical activity, dietary habits, sleep quality, and health 
behaviour. 
3. Assess parents' and children's attitudes toward health and the living environment. 
4. Evaluate the impact of physical activity and sleep on children's health. 
5. Assess the effectiveness of smart wristbands as a tool for monitoring physical activity, 
sleep, and heart function. 
6.  Reassess children's health indicators after 3 months and compare them with baseline data. 
5. Detailed Description of the Study Outcomes (Primary and Secondary Study Endpoints) 
The Connection project will evaluate the following outcomes 
Primary outcomes: Children's blood pressure, anthropometric data (height, weight), body fat 
percentage, physical activity levels, depending on exposure, socioeconomic status, and healthy 
lifestyle. 
Secondary outcomes: Children's well-being depending on exposure, socioeconomic status, and 
healthy lifestyle. 
6. Justification of the Biomedical Research 

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This new international study is conducted at Vytautas Magnus University under the European 
Commission’s ERA4health call, funded by the Research Council of Lithuania. The international 
project coordinator is the University of Porto, Portugal. Poor nutrition and insufficient physical 
activity are among the main behavioural risk factors for non-communicable diseases.1. A higher 
prevalence of unhealthy behaviours in lower socio-economic groups is one of the mechanisms 
linking disadvantaged social and economic conditions to poorer health indicators. Furthermore, 
diet and physical activity are potentially modifiable behavioural factors that partly explain socio-
economic differences in morbidity and mortality2. Promoting positive behaviours, particularly 
among people of lower social status, is a public health priority. Therefore, changes in social norms 
and living environments that shape behaviour, encouraging individuals to adopt more balanced 
dietary habits and be physically active, should be considered essential primary prevention 
measures to promote health and well-being. Target populations and various stakeholders should 
actively participate in designing, implementing, and evaluating measures aimed at creating 
healthier and more sustainable environments3. 
Based on the WHO's "health in all policies" concept, these interventions should integrate public 
health approaches to tackle complex problems and emphasize the importance of scientific 
progress, public awareness and advocacy, consumer demand, industrial innovations, government 
regulation, and cultural changes4. 
The effectiveness of public health strategies may vary among social and economic groups and may 
even increase inequality5. Adverse environmental influences and negative social incentives are 
particularly strong and have a profound impact on children and adolescents growing up in 
disadvantaged neighbourhoods, exposing them to higher health risks. Young people living in 
unfavourable conditions are particularly difficult to engage in current programs and therefore do 
not benefit from existing community interventions. Changing nutrition, physical activity, and 
movement habits is a complex and time-consuming process that requires involving community 
members and local authorities and empowering them. The engagement process should be 
particularly attentive to people living in vulnerable conditions. 
Moreover, previous research shows that, in youth populations, there is increasing interest in 
addressing food surplus and food-sharing practices in school catering facilities and food education 
activities as a way to tackle social nutritional disparities. 
7. Description of Study Participants 
The Connection study will include children aged 12–16 attending VDU Atžalynas Progymnasium. 
Selection will be random, involving approximately 200 children (±10%) who will participate in 
the initial cross-sectional study. From these participants, about 10% (around 20 children ±2) will 
be invited to take part in an in-depth interventional study. All children participating in the study 
 
1 Stanaway JD, Afshin A, Gakidou E, et al. Global, regional, and national comparative risk assessment of 84 behavioural, environmental and 
occupational, and metabolic risks or clusters of risks for 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of 
Disease Stu. Lancet. 2018 Nov;392(10159):1923–94. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0140673618322256 
2 Stringhini S, Carmeli C, Jokela M, et al. Socioeconomic status and the 25 × 25 risk factors as determinants of premature mortality: a multicohort 
study and meta-analysis of 1·7 million men and women. Lancet. 2017 Mar 25;389(10075):1229- 1237. doi: 10.1016/S0140-6736(16)32380-7. 
3 Leask CF, Sandlund M, Skelton DA, et al; GrandStand, Safe Step and Teenage Girls on the Move Research Groups. Framework, principles and 
recommendations for utilising participatory methodologies in the co-creation and evaluation of public health interventions. Res Involv Engagem. 
2019 Jan 9;5:2. doi: 10.1186/s40900-018-0136-9. 
4 Lang T, Rayner G. Beyond the Golden Era of public health: charting a path from sanitarianism to ecological public health. Public Health. 2015 
Oct;129(10):1369–82. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0033350615003029 
5 Lorenc T, Petticrew M, Welch V, et al. What types of interventions generate inequalities? Evidence from systematic reviews. J Epidemiol 
Community Health. 2013;67(2):190–3. 

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will be required to sign informed consent forms together with their parents (or legal guardians) 
and will be allowed to choose in which phase of the study they wish to participate. 
Children will be excluded from the study if they do not meet the age criteria (younger than 12 or 
older than 16 years), if their parents or guardians refuse to sign the informed consent form, if they 
have health conditions that could interfere with the study or pose a health risk, or if they are 
unwilling to comply with study requirements, such as refusing to wear a smart wristband. 
8. Methodology of the Biomedical Research 
The Connection study consists of two stages: a cross-sectional study (initial research) and an in-
depth interventional study. These stages are interconnected and aim to assess children’s health and 
physical parameters as well as the impact of environmental factors: 
1. Cross-sectional study (initial research): This stage will include children aged 12–16 
attending VDU Atžalynas Progymnasium. Approximately 200 children (±10%) will be 
randomly selected to participate once. 
Study procedures: 
Children and their parents will be asked to complete questionnaires: 
• Child questionnaire: Covers health behaviour, well-being, and environmental 
assessment. 
• Parent questionnaire: Covers social and demographic indicators, home address (required 
for individual air pollution assessment). 
Measurements for children will include: 
• Blood pressure6; 
• Anthropometric measurements: height (cm) and weight (kg)7; 
• Body composition analysis8. 
All devices will have CE certification. Filling in the questionnaires will take up to 20 minutes, and 
measurements up to 10 minutes. The total procedure duration will be about 30 minutes. The 
collected questionnaire data will include social, demographic, health behaviour, well-being, and 
environmental assessment indicators. Information will be coded to prevent linking a child’s name 
to the ID number. Data from paper questionnaires will be entered into computer software. All data 
will be recorded on digital data collection sheets and stored in the research database following data 
protection requirements. 
2. In-depth interventional study: This stage will involve about 10% of the participants from 
the cross-sectional study (around 20 children) who agree to take part in a 7-day physical 
activity monitoring study. 
Study procedures: 
Participants will attend a two-visit program: 
First visit: Initial assessment during which: 
• A CE-certified smart wristband is placed on the participant to monitor physical activity, 
heart function, and sleep quality for 7 days. 
• After 7 days: Participants return the wristbands and provide verbal feedback about their 
study experience. 
Second follow-up visit after 3 months: 
 
6 Prietaisas Omron M3W (HEM-7202-E(V)) 
7 Prietaisas Kern MPE (250K100HM) 
8 Prietaisas Tanita MC780 

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• Blood pressure, height, weight, and body composition are re-measured (duration up to 10 
minutes). 
• Participants wear smart wristbands again for 7 days. 
• After 7 days: Participants return the wristbands and complete a short questionnaire about 
their experience. 
Data on residential addresses collected during the cross-sectional study will be linked to the 
environmental pollution database (PM2.5, PM10, NO2) and children’s physical health indicators. 
During the in-depth study, changes in physical activity and sleep will be analysed to assess the 
impact of the intervention on health. All participants will be informed about the study aims and 
procedures. Participation is voluntary, and all data will be coded and protected according to data 
protection regulations. No methods used in either stage are expected to cause adverse or long-term 
health effects. 
9. Description of Locations and Institutions Where Biomedical Research Will Be 
Conducted 
Participants of the Connection Project: 
Porto, Portugal: Population Health Integrated and Applied Research Laboratory, University of 
Porto, Institute of Public Health – Research Institute – National Science and Technology Fund 
Ghent, Belgium: Ghent University, Faculty of Bioscience Engineering, Department of Food 
Technology, Safety and Health – University – Regional Fund Wetenschappelijk Onderzoek 
(FWO) 
Turin, Italy: Department of Medical Sciences, University of Turin – University – National Ministry 
of Universities and Scientific Research of Italy 
Amsterdam, Netherlands: Center for Research and Innovation in Child and Adolescent Public 
Health; Department of Public and Occupational Health; Health Behavior and Chronic Diseases; 
Amsterdam Public Health Research Institute; Stichting VUmc – University – Netherlands 
Organization for Health Research and Development 
Frederiksberg, Denmark: Department of Geosciences and Natural Resource Management, 
University of Copenhagen – University – Danish Innovation Fund 
Kaunas, Lithuania: Department of Environmental Sciences, Vytautas Magnus University (VMU) 
– University – Research Council of Lithuania 
Riga, Latvia: Riga Stradins University, Department of Sports and Nutrition – University – National 
Research Council of Latvia 
Barcelona, Spain: ISGlobal Research Institute – Research Institute – Associated Participant 
 
10. Planned Duration of the Entire Biomedical Research 
The study will last 36 months. 
 
11. Duration of Participant Involvement in the Biomedical Research 
 
Participant involvement depends on the study stage: 
Cross-sectional study: One-time participation lasting up to 30 minutes (20 minutes for 
questionnaires, 10 minutes for measurements). 

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In-depth study: Two 7-day periods of wearing a smart wristband, two visits, and a follow-up 
assessment after 3 months (total: ~20 minutes per visit). 
 
12. Criteria for Terminating Participation in the Biomedical Research 
Participants may withdraw at any time. Consent can be revoked by the participant or their 
parent/legal guardian if the participant is deemed incapable of making reasonable decisions due to 
health conditions. Withdrawal does not require justification. Data collected before withdrawal will 
not be deleted. 
 
13. Procedure for Inviting Participants to the Biomedical Research 
The invitation of participants to the biomedical research will be organized in close cooperation 
with VDU Atžalynas Progymnasium, whose students constitute the target study group. The 
target group for this research is children aged 12–16. 
The school administration and teachers will be introduced to the aim of the study, methodology, 
and participant selection criteria. With the school’s assistance, an effective information 
dissemination channel will be ensured. Information invitations to participate in the study will be 
distributed to potential participants and their parents, clearly presenting the study’s purpose, 
procedures, potential benefits and risks, and participation conditions. Parents will also be informed 
via school email or other internal communication systems. Invitations will be sent through 
electronic diaries or other school information channels. 
Information meetings will be organized to allow parents and students to learn about the study’s 
objectives, ask questions directly to the researchers, and receive detailed answers. These meetings 
aim to ensure that potential participants and their parents make an informed decision about 
participation. After these meetings, informed consent forms will be distributed to parents, who will 
be asked to complete and return them if they agree to participate. Children will also sign a consent 
form adapted to their level of understanding. 
Participants for the cross-sectional study will be randomly selected from students who agreed to 
participate. Later, participants for the interventional part of the study will be selected based on the 
10% sampling principle, from those who indicated willingness to take part in the in-depth study in 
the questionnaires. 
This procedure ensures that participants and their parents receive comprehensive information, can 
make an informed choice about participation, and that the recruitment process is transparent and 
effective. 
14. Procedure for Informing About the Study and Obtaining Informed Consent 
Both parents/legal guardians and children will receive detailed information about the 
study, its objectives, procedures, benefits, and risks. 
The procedure for enrolling participants in the biomedical research and obtaining informed consent 
will strictly follow ethical and legal requirements, ensuring participants' awareness, voluntariness, 
and data confidentiality. Since the study involves minors (children aged 12–16), their participation 
requires both parental or guardian consent and the child’s own assent. 
During the initial meeting, if parents and children agree to participate in the biomedical research, 
informed consent forms will be provided. These forms will be given to both parents (legal 

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representatives) and children (12–16 years old). Before signing, parents and children will receive 
detailed information about the study’s procedures and possible outcomes. The target population, 
study objectives, applied methods and procedures, duration, and significance for participants and 
society will be explained. They will also be informed about their rights, including the right to 
receive information about the study’s progress, the right to withdraw without negative 
consequences, and the right to have all questions answered regarding the study. Children and 
parents will be informed about potential risks or inconveniences, such as possible side effects or 
unexpected discomforts. Ethical committee decisions and approvals will be presented to ensure 
the study adheres to the highest ethical standards and safeguards participants' well-being. 
It will be clearly stated that parents and children have the right to withdraw their consent in writing 
at any time, regardless of the study stage, without affecting their rights or access to necessary 
services. All collected participant information will be kept confidential and used only for research 
purposes in compliance with applicable legal requirements. 
After the meeting, once parents and children are fully informed and have no further questions, they 
will be asked to sign the informed consent forms. These forms will confirm that both parents (legal 
representatives) and children fully understand the study procedures, associated risks, benefits, 
rights, and obligations, and voluntarily agree to participate in the biomedical research. The 
informed consent forms will be prepared in two copies. 
15. Possible Benefits of the Biomedical Research for Participants 
Participants in the biomedical research will not receive direct personal benefits. However, they 
will contribute to important scientific discoveries that may, in the future, improve disease 
diagnosis, treatment, or prevention for themselves and the wider population. Participants and their 
parents will have the opportunity to receive detailed results of the body composition analysis, 
including individual values of the child’s body composition (e.g., fat, muscle, bone mass) and a 
comparison with recommended norms. 
 
16. Possible Risks and Inconveniences for Participants 
 
Minimal inconvenience is expected (short time commitment, no routine disruption). Data will be 
anonymized and coded in line with data protection regulations. 
 
17. Documentation and Assessment of Adverse Events 
No harmful procedures are involved. If unexpected health issues arise, they will be reported to 
the family doctor and school administration. 
 
18. Data Processing, Confidentiality, and Protection 
During the biomedical research, socio-demographic data (age, sex, residential address), health data 
(blood pressure, height, weight, body composition indicators, physical activity, sleep, and heart 
rate data from the smart wristband), and subjective evaluations (health behavior, environmental 
assessment, and well-being questionnaire responses) will be collected. Data will only be obtained 

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from participants and their parents through questionnaires, physical measurements, and smart 
wristbands. 
All collected data will be coded with a unique identification number (ID) not linked to the 
participant’s name or surname. Paper documents will be anonymized, and digital data will be 
encrypted and stored in electronic systems. Access to uncoded data will be limited to researchers 
directly involved in the study, if necessary (e.g., contacting the participant’s family). Oversight 
authorities or ethics committees may also access uncoded data during audits or monitoring. 
Questionnaire data will be available to the principal investigator, authorized researchers, the 
biomedical research centre’s investigator conducting health checks, and supervising authorities 
(bioethics committees). Coded health data will be accessible to researchers, scientists preparing 
reports and publications for academic and public dissemination, and the study sponsor solely for 
analytical purposes. 
Data from questionnaires and clinical assessments will be entered into an electronic system. A 
database linking personal data and assigned codes will be created and stored on the principal 
investigator’s password-protected computer at the VMU research center. Data collected will be 
transferred via USB every 10 days to the principal investigator’s computer and linked to the 
assigned identification codes. The principal investigator will be responsible for storing data on 
electronic media for 5 years after study completion. Both the database containing identifiable 
information and the anonymized dataset will be securely stored at VMU. Access to data is only 
possible with the computer’s password. 
In line with the international protocol, anonymized coded data will be shared with consortium 
partners for complex data analyses and aggregated for joint publications. 
The data controller is the study sponsor or the institution responsible for the research. For this 
study, the data controller is VMU, Faculty of Natural Sciences. Upon request, participants can 
access their personal data and request corrections or additions if inaccuracies are found by visiting 
the principal investigator or authorized staff at the VMU research center. 
Project data will be stored for 5 years after study completion under the responsibility of the 
principal investigator. Participants or their parents can withdraw consent in writing at any time. 
Participation will then be immediately terminated, and all data will be deleted unless this conflicts 
with legal obligations. Withdrawal will not result in any negative consequences for the participant 
or their family. These principles ensure the protection of participants’ rights, privacy, and data 
security throughout the study. 
 
19. Criteria for Amending the Biomedical Research Protocol 
Changes are only allowed with approval from the international supervisory committee and the 
Kaunas Regional Biomedical Research Ethics Committee. Minor modifications can be made under 
unforeseen circumstances with scientific justification. 
 
20. Compensation for Time and Expenses 
No compensation or payment will be provided. Participation is voluntary and non-disruptive. 
 
21. Funding of the Biomedical Research 

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Funded by the Research Council of Lithuania under the European Commission's Era4Health 
program. 
 
22. Compensation for Potential Harm (Insurance) 
Not applicable. No harm to participants is expected. 
 
23. Publication of Results 
Results will be published in scientific journals, presented at conferences, and used to develop 
recommendations for increasing physical activity among students. 
 
24. Description of Ethical Issues Related to the Biomedical Research, If Not Discussed 
Elsewhere 
Ethical issues are discussed in Section 14, describing the process of informing participants about 
the biomedical research and obtaining informed consent to participate in the study. 
 
25. Confirmation Regarding Use of Medicines Compensated from the Mandatory Health 
Insurance Fund 
Not applicable. 
 
26. Confirmation of Compliance with Legal Requirements 
Researchers confirm adherence to Lithuanian biomedical research regulations and the approved 
protocol, with notification of any changes and reporting to the Kaunas Regional Biomedical 
Research Ethics Committee. 
 
27. Explanation of the Documents from Institutions Granting Permission to Conduct the 
Biomedical Research and Confirmation that the Researcher (Institution) Will Allow 
Oversight, Audits, Ethical Supervision, and Inspections with Direct Access to Source 
Documents (Data Sources) 
Documents Granting Permission to Conduct the Study and Confirmation of Oversight 
The study will only begin after receiving approval from the Kaunas Regional Biomedical Research 
Ethics Committee. Necessary institutional permissions from VDU Atžalynas Progymnasium will 
be obtained to allow control, audits, ethical supervision, and direct access to source data. 
 
28. Signatures of the Biomedical Research Protocol Author(s), Principal Investigator, 
and Sponsor's Representative 
Protocol Author: Dr. Sandra Andrušaitytė 

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Principal Investigator: Dr. Sandra Andrušaitytė 
Sponsor's Representative: Vice-Rector for Research, Vytautas Magnus University – Prof. Dr. 
Julija Kiršienė