Overweight, ChildhoodDINO-PLNCT07357857
High Five! - School-based Prevention of Overweight and Obesity Among 6 to 9 Year Olds
A study testing High Five in people with Overweight, Childhood and Obesity Prevention, run by Institute of Mother and Child, Warsaw, Poland at 1 site in Poland.
Trial summary
The goal of this interventional study is to assess the effectiveness of the school-based "High Five!" program in reducing overweight, obesity and high blood pressure in children aged 7-9 years old. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Childhood, Obesity Prevention, Blood Pressure
- What is being tested?
- High Five
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 659 participants
- Where
- 1 sitePoland
- Study dates
- 23 Apr 2025to 28 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Primary schools (public, private, general, inclusive) being a student at a school/class taking part in the study
Who cannot join
- Special schools lack of parental consent for the child to participate in the program lack of child's oral consent to participat
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of the "High Five!" Program for Reducing the Risk of Overweight and Obesity in Early School-age Children
The goal of this interventional study is to assess the effectiveness of the school-based "High Five!" program in reducing overweight, obesity and high blood pressure in children aged 7-9 years old. The main questions it aims to answer are:
- Does participation in the "High Five!" program reduce the proportion of child participants with elevated body mass index (BMI), waist and hip circumference, and blood pressure?
- Does participation in the "High Five!" program increase adherence to recommended health behaviors (healthy eating, physical activity, screen time management, and sleep hygiene) among participating children? Researchers compare "High Five!" to the school practice as usual to see if this program works to prevent overweight and related health problems in children.
Read more
Students participate in 6 sessions. Sessions 1-5 are dedicated to five health-related topics such as mental health, nutrition, physical activity, screen time and sleep while session 6 serves as a summarizing and reinforcing lesson. Sessions are based on active methods (play, individual / small group work) and carried out in accordance with detailed scenarios by trained specialists: the class teacher and the school nurse.
Parents/guardians of participating students are engaged in promoting healthy behaviors and creating a supportive home environment via self-reading of the "portions of knowledge" on the topics covered by the program and completion of home tasks with their children.
Read the detailed description
Background:
Excessive body weight in children is a serious and increasing health problem associated with: elevated blood pressure, risk of obesity in adulthood, poor relationships with peers, negative perception by other (as of lower intelligence, lazy etc.), susceptibility to bullying, low self-esteem and a critical attitude towards oneself.
The key risk factors of overweight in children include: low physical activity, sedentary behaviours, unbalanced diet (too much sugar-sweetened beverages and fast food), sleep disorders and mental health problems.
There are many interventions aimed at reducing overweight and obesity among children, especially those implemented in school settings. However, there is no clear evidence regarding their long-term effectiveness on obesity-related outcomes.
Objectives:
The goal of this clinical trial is to assess the effectiveness of the school-based "High Five!" program in reducing overweight, obesity and high blood pressure in children aged 6-9 years old. The main questions it aims to answer are:
- Does participation in the "High Five!" program reduce the proportion of child participants with elevated body mass index (BMI), waist and hip circumference, and blood pressure?
- Does participation in the "High Five!" program increase adherence to recommended health behaviors (healthy eating, physical activity, screen time management, and sleep hygiene) among participating children?
Intervention:
The High Five! Program is based on the Life course theory claiming that people pass through a sequence of age-based stages and social roles within particular social structures over their lifetime that affects their health, including their body mass. The process of acquiring the skills necessary for living and acting in society to achieve life goals is extremely intensive at the beginning of school, influenced by the social environment. Children learn what behaviors are expected of them and whether they do what they do correctly. Skills acquired at this age and in this environment (classroom) help them cope with new circumstances in the future, thus becoming a lifelong asset. In this context, involving parents in the intervention via assignments, meetings, informative material and encouraging them to improve the home environment is one of the key determinants of the effectiveness of the intervention. In accordance with the family-individual-school (FIS) model of comprehensive childhood obesity prevention, "students connect the family and school, whereas parents collaborate with the school to contribute to the intervention program".
The High Five! Program is adapted to the developmental age of the 7-9 years old participants for whom, play is the favorite form of activity. Children of this age are entering a period of developing perseverance and diligence. Thay want to learn more than ever in their later lives. Therefore, it is extremely important to maintain their enthusiasm and create conditions at school that promote well-being and success. The greatest threat during this period is the child developing a belief in their own low self-worth. Children at this age enjoy listening to and telling stories, which they also use in play. They also enjoy making their own toys. They have good memory skills, especially rhymes and songs. Repetition of the same information promotes memorization. This period is also characterized by the ease of acquiring new motor skills and their improvement. This has a positive impact on daily activities, exercise, participation in sports, crafts, and playing musical instruments. And schoolteachers trained to implement health promoting interventions can have a significant impact on students' dietary behaviors.
The High Five! Program aims to prevent overweight, obesity and high blood pressure in children, by:
- Familiarizing children with health recommendations (eating, sleep, sedentary behaviours, physical activity)
- Strengthening children's skills (positive self-esteem - liking oneself, healthy eating and sleeping, physical activity, screen time control)
- Strengthening the potential of parents to support a healthy lifestyle for their child (modelling of healthy behaviours, encouraging children to follow recommendations, supporting child's positive self-esteem)
The High Five! Program activities include:
- Students participation in 6 sessions. Sessions 1-5 (90 minutes each) are dedicated to five health-related topics:
- SUPERPOWERS AND SUPER THOUGHTS- Strengthening positive self-esteem and the ability to see own strengths;
- BECOME A CHEF! - Familiarizing children with the current principles of healthy eating and enhance their ability to properly compose meals;
- MOVEMENT IS HEALTHY - Familiarize children with the current recommendations for physical activity and motivate them to move ;
- TAKE A BREAK - Strengthening motivation and ability to control screen time;
- HEALTHY SLEEP - Familiarizing children with the current recommendations for the sleep hours and how to prepare to sleep;
- HIGH FIVE FOR HEALTH (45 minutes) - Summarizes and strengthens the program's message in the form of an educational board game. Sessions are based on active methods (play, individual / small group work) and carried out in accordance with detailed scenarios by trained specialists: the class teacher and the school nurse.
- Parents' engagement in promoting healthy behaviors and creating a supportive home environment via self-reading of the "portions of knowledge" on the topics covered by the program: mental health, physical activity, nutrition, sleep and screen-time and Completion of home tasks with their children (after the sessions 1-5).
Study design Researchers compare "High Five!" to the school practice as usual to see if this program works to prevent overweight and related health problems in children. The cluster randomized control trial (cRCT) design with a 1:1 ratio (experimental group vs. control group) is applied. The sampling unit is the school, and the sampling is stratified based on the size of the locality (rural/small town/large city). In each school, first- and/or second-grade classes are selected to participate. The characteristics of school environment in terms of systemic/organizational solutions at school that promote healthy eating, physical activity and a social climate friendly to students and parents will be taken into account in the outcome analysis.
Data collection is conducted in four phases: baseline (shortly before the first program session), mid-intervention (in average - after two weeks , post-intervention (shortly after the last program session), and 6-month follow-up. The evaluation includes standardized anthropometric measurements and questionnaires. Children are assessed by school nurses four times, using the Child Examination Report (height, weight, waist/hip circumference, blood pressure). Parents complete a questionnaire evaluating their child's health behaviors (e.g. diet, physical activity, screen time, sleep), emotional well-being (PSC-17), and their own health-related knowledge and supportive parenting practices 3 times (at the baseline, post-intervention and at the follow-up). Students evaluate their own health-related behaviors by marking on the picture scale, for how many days in the last 7 days, they did each of them. They answer the same question four times (at the baseline, mid-intervention, post-intervention, and 6-month follow-up). School staff (e.g., principals) will complete a questionnaire assessing the school's capacity to promote healthy behaviors. This includes food and beverage availability, opportunities for physical activity, school health policies, and implementation of health promotion initiatives.
- Conditions
- Overweight, Childhood, Obesity Prevention, Blood Pressure
- Being tested
- High Five
- Keywords
- children, school-based intervention, overweight prevention, non-communicable diseases prevention, health promotion, health education
- Medical subject headings
- Pediatric Obesity, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High FiveBehavioural
The "High Five!"program is based on the Life course theory and family-individual-school (FIS) model. Students are the main target groups of the program, and parents cooperate with the school to enhance the effects of the intervention.
Activities addressed to students include the implementation of 6 scenarios, concerning health-related issues, carried out in accordance with detailed scenarios by trained teacher and school nurse. Parents support th program by performing special home tasks together with the child.
| Study group | Role | What they receive |
|---|---|---|
| Students from classes participating in the "High Five!" program | Experimental | High Five! Receives: Behavioral: High Five |
| Students from classes not participating in the "High Five!" program | No intervention | school practice as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the BMI z-score at 6 month
Measured: From enrollment to the end of the follow-up at 6 month
Secondary outcomes (2)
Change from Baseline in the percentage of students with values indicating increased Systolic Blood Pressure at 6 Months
Measured: From enrollment to the end of the follow-up at 6 month
Change from Baseline in the percentage of students with values indicating increased Diastolic Blood Pressure at 6 Months
Measured: From enrollment to the end of the follow-up at 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start23 Apr 2025
- Primary completion28 Nov 2025
- Study completion28 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Overweight, ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 659 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Mother and Child, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Poland
- Responsible party
- Principal investigator, Prof. Anna Fijałkowska, Institute of Mother and Child, Warsaw, Poland
- Investigators
- Anna Fijałkowska, Professor, Principal investigator, Institute of Mother and Child
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357857
- Sponsor's protocol ID
- 6/11/85195/NPZ/2021/106/830
- Acronym
- DINO-PL
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cao ZJ, Wang SM, Chen Y. A randomized trial of multiple interventions for childhood obesity in China. Am J Prev Med. 2015 May;48(5):552-60. doi: 10.1016/j.amepre.2014.12.014.
PubMed 25891054Wang Y, Cai L, Wu Y, Wilson RF, Weston C, Fawole O, Bleich SN, Cheskin LJ, Showell NN, Lau BD, Chiu DT, Zhang A, Segal J. What childhood obesity prevention programmes work? A systematic review and meta-analysis. Obes Rev. 2015 Jul;16(7):547-65. doi: 10.1111/obr.12277. Epub 2015 Apr 20.
PubMed 25893796Telama R. Tracking of physical activity from childhood to adulthood: a review. Obes Facts. 2009;2(3):187-95. doi: 10.1159/000222244. Epub 2009 Jun 12.
PubMed 20054224Smit MS, Boelens M, Molenberg FJM, Raat H, Jansen W. The long-term effects of primary school-based obesity prevention interventions in children: A systematic review and meta-analysis. Pediatr Obes. 2023 Mar;18(3):e12997. doi: 10.1111/ijpo.12997. Epub 2022 Dec 21.
PubMed 36545748Sluggett L, Wagner SL, Harris RL. Sleep Duration and Obesity in Children and Adolescents. Can J Diabetes. 2019 Mar;43(2):146-152. doi: 10.1016/j.jcjd.2018.06.006. Epub 2018 Jul 4.
PubMed 30266216Simmonds M, Llewellyn A, Owen CG, Woolacott N. Predicting adult obesity from childhood obesity: a systematic review and meta-analysis. Obes Rev. 2016 Feb;17(2):95-107. doi: 10.1111/obr.12334. Epub 2015 Dec 23.
PubMed 26696565Rousham EK, Goudet S, Markey O, Griffiths P, Boxer B, Carroll C, Petherick ES, Pradeilles R. Unhealthy Food and Beverage Consumption in Children and Risk of Overweight and Obesity: A Systematic Review and Meta-Analysis. Adv Nutr. 2022 Oct 2;13(5):1669-1696. doi: 10.1093/advances/nmac032.
PubMed 35362512Lambrinou CP, Androutsos O, Karaglani E, Cardon G, Huys N, Wikstrom K, Kivela J, Ko W, Karuranga E, Tsochev K, Iotova V, Dimova R, De Miguel-Etayo P, M Gonzalez-Gil E, Tamas H, Jancso Z, Liatis S, Makrilakis K, Manios Y; Feel4Diabetes-study group. Effective strategies for childhood obesity prevention via school based, family involved interventions: a critical review for the development of the Feel4Diabetes-study school based component. BMC Endocr Disord. 2020 May 6;20(Suppl 2):52. doi: 10.1186/s12902-020-0526-5.
PubMed 32370795Kulaga Z, Swiader-Lesniak A, Kotowska A, Litwin M. Population-based references for waist and hip circumferences, waist-to-hip and waist-to-height ratios for children and adolescents, and evaluation of their predictive ability. Eur J Pediatr. 2023 Jul;182(7):3217-3229. doi: 10.1007/s00431-023-05001-4. Epub 2023 May 4.
PubMed 37140701Jebeile H, Kelly AS, O'Malley G, Baur LA. Obesity in children and adolescents: epidemiology, causes, assessment, and management. Lancet Diabetes Endocrinol. 2022 May;10(5):351-365. doi: 10.1016/S2213-8587(22)00047-X. Epub 2022 Mar 3.
PubMed 35248172Jakobsen DD, Brader L, Bruun JM. Association between Food, Beverages and Overweight/Obesity in Children and Adolescents-A Systematic Review and Meta-Analysis of Observational Studies. Nutrients. 2023 Feb 2;15(3):764. doi: 10.3390/nu15030764.
PubMed 36771470Habib-Mourad C, Ghandour LA, Maliha C, Awada N, Dagher M, Hwalla N. Impact of a one-year school-based teacher-implemented nutrition and physical activity intervention: main findings and future recommendations. BMC Public Health. 2020 Feb 19;20(1):256. doi: 10.1186/s12889-020-8351-3.
PubMed 32075607Cockerham WC. Theoretical Approaches to Research on the Social Determinants of Obesity. Am J Prev Med. 2022 Jul;63(1 Suppl 1):S8-S17. doi: 10.1016/j.amepre.2022.01.030.
PubMed 35725145Calcaterra V, Cena H, Magenes VC, Vincenti A, Comola G, Beretta A, Di Napoli I, Zuccotti G. Sugar-Sweetened Beverages and Metabolic Risk in Children and Adolescents with Obesity: A Narrative Review. Nutrients. 2023 Jan 30;15(3):702. doi: 10.3390/nu15030702.
PubMed 36771409Bornhorst C, Wijnhoven TM, Kunesova M, Yngve A, Rito AI, Lissner L, Duleva V, Petrauskiene A, Breda J. WHO European Childhood Obesity Surveillance Initiative: associations between sleep duration, screen time and food consumption frequencies. BMC Public Health. 2015 Apr 30;15:442. doi: 10.1186/s12889-015-1793-3.
PubMed 25924872
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the "High Five!" Program for Reducing the Risk of Overweight and Obesity in Early School-age Children
- ClinicalTrials.gov ID
- NCT07357857
- Acronym / sponsor ID
- DINO-PL / 6/11/85195/NPZ/2021/106/830
- Conditions
- Overweight, Childhood, Obesity Prevention, Blood Pressure
- Keywords
- children, school-based intervention, overweight prevention, non-communicable diseases prevention, health promotion, health education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 659 participants (actual)
- Lead sponsor
- Institute of Mother and Child, Warsaw, PolandUniversity, hospital or other
- Collaborators
- Ministry of Health, Poland
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 28 Nov 2025 (actual)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this interventional study is to assess the effectiveness of the school-based "High Five!" program in reducing overweight, obesity and high blood pressure in children aged 7-9 years old. The main questions it aims to answer are:
- Does participation in the "High Five!" program reduce the proportion of child participants with elevated body mass index (BMI), waist and hip circumference, and blood pressure?
- Does participation in the "High Five!" program increase adherence to recommended health behaviors (healthy eating, physical activity, screen time management, and sleep hygiene) among participating children? Researchers compare "High Five!" to the school practice as usual to see if this program works to prevent overweight and related health problems in children.
Students participate in 6 sessions. Sessions 1-5 are dedicated to five health-related topics such as mental health, nutrition, physical activity, screen time and sleep while session 6 serves as a summarizing and reinforcing lesson. Sessions are based on active methods (play, individual / small group work) and carried out in accordance with detailed scenarios by trained specialists: the class teacher and the school nurse.
Parents/guardians of participating students are engaged in promoting healthy behaviors and creating a supportive home environment via self-reading of the "portions of knowledge" on the topics covered by the program and completion of home tasks with their children.
Detailed description
Background:
Excessive body weight in children is a serious and increasing health problem associated with: elevated blood pressure, risk of obesity in adulthood, poor relationships with peers, negative perception by other (as of lower intelligence, lazy etc.), susceptibility to bullying, low self-esteem and a critical attitude towards oneself.
The key risk factors of overweight in children include: low physical activity, sedentary behaviours, unbalanced diet (too much sugar-sweetened beverages and fast food), sleep disorders and mental health problems.
There are many interventions aimed at reducing overweight and obesity among children, especially those implemented in school settings. However, there is no clear evidence regarding their long-term effectiveness on obesity-related outcomes.
Objectives:
The goal of this clinical trial is to assess the effectiveness of the school-based "High Five!" program in reducing overweight, obesity and high blood pressure in children aged 6-9 years old. The main questions it aims to answer are:
- Does participation in the "High Five!" program reduce the proportion of child participants with elevated body mass index (BMI), waist and hip circumference, and blood pressure?
- Does participation in the "High Five!" program increase adherence to recommended health behaviors (healthy eating, physical activity, screen time management, and sleep hygiene) among participating children?
Intervention:
The High Five! Program is based on the Life course theory claiming that people pass through a sequence of age-based stages and social roles within particular social structures over their lifetime that affects their health, including their body mass. The process of acquiring the skills necessary for living and acting in society to achieve life goals is extremely intensive at the beginning of school, influenced by the social environment. Children learn what behaviors are expected of them and whether they do what they do correctly. Skills acquired at this age and in this environment (classroom) help them cope with new circumstances in the future, thus becoming a lifelong asset. In this context, involving parents in the intervention via assignments, meetings, informative material and encouraging them to improve the home environment is one of the key determinants of the effectiveness of the intervention. In accordance with the family-individual-school (FIS) model of comprehensive childhood obesity prevention, "students connect the family and school, whereas parents collaborate with the school to contribute to the intervention program".
The High Five! Program is adapted to the developmental age of the 7-9 years old participants for whom, play is the favorite form of activity. Children of this age are entering a period of developing perseverance and diligence. Thay want to learn more than ever in their later lives. Therefore, it is extremely important to maintain their enthusiasm and create conditions at school that promote well-being and success. The greatest threat during this period is the child developing a belief in their own low self-worth. Children at this age enjoy listening to and telling stories, which they also use in play. They also enjoy making their own toys. They have good memory skills, especially rhymes and songs. Repetition of the same information promotes memorization. This period is also characterized by the ease of acquiring new motor skills and their improvement. This has a positive impact on daily activities, exercise, participation in sports, crafts, and playing musical instruments. And schoolteachers trained to implement health promoting interventions can have a significant impact on students' dietary behaviors.
The High Five! Program aims to prevent overweight, obesity and high blood pressure in children, by:
- Familiarizing children with health recommendations (eating, sleep, sedentary behaviours, physical activity)
- Strengthening children's skills (positive self-esteem - liking oneself, healthy eating and sleeping, physical activity, screen time control)
- Strengthening the potential of parents to support a healthy lifestyle for their child (modelling of healthy behaviours, encouraging children to follow recommendations, supporting child's positive self-esteem)
The High Five! Program activities include:
- Students participation in 6 sessions. Sessions 1-5 (90 minutes each) are dedicated to five health-related topics:
- SUPERPOWERS AND SUPER THOUGHTS- Strengthening positive self-esteem and the ability to see own strengths;
- BECOME A CHEF! - Familiarizing children with the current principles of healthy eating and enhance their ability to properly compose meals;
- MOVEMENT IS HEALTHY - Familiarize children with the current recommendations for physical activity and motivate them to move ;
- TAKE A BREAK - Strengthening motivation and ability to control screen time;
- HEALTHY SLEEP - Familiarizing children with the current recommendations for the sleep hours and how to prepare to sleep;
- HIGH FIVE FOR HEALTH (45 minutes) - Summarizes and strengthens the program's message in the form of an educational board game. Sessions are based on active methods (play, individual / small group work) and carried out in accordance with detailed scenarios by trained specialists: the class teacher and the school nurse.
- Parents' engagement in promoting healthy behaviors and creating a supportive home environment via self-reading of the "portions of knowledge" on the topics covered by the program: mental health, physical activity, nutrition, sleep and screen-time and Completion of home tasks with their children (after the sessions 1-5).
Study design Researchers compare "High Five!" to the school practice as usual to see if this program works to prevent overweight and related health problems in children. The cluster randomized control trial (cRCT) design with a 1:1 ratio (experimental group vs. control group) is applied. The sampling unit is the school, and the sampling is stratified based on the size of the locality (rural/small town/large city). In each school, first- and/or second-grade classes are selected to participate. The characteristics of school environment in terms of systemic/organizational solutions at school that promote healthy eating, physical activity and a social climate friendly to students and parents will be taken into account in the outcome analysis.
Data collection is conducted in four phases: baseline (shortly before the first program session), mid-intervention (in average - after two weeks , post-intervention (shortly after the last program session), and 6-month follow-up. The evaluation includes standardized anthropometric measurements and questionnaires. Children are assessed by school nurses four times, using the Child Examination Report (height, weight, waist/hip circumference, blood pressure). Parents complete a questionnaire evaluating their child's health behaviors (e.g. diet, physical activity, screen time, sleep), emotional well-being (PSC-17), and their own health-related knowledge and supportive parenting practices 3 times (at the baseline, post-intervention and at the follow-up). Students evaluate their own health-related behaviors by marking on the picture scale, for how many days in the last 7 days, they did each of them. They answer the same question four times (at the baseline, mid-intervention, post-intervention, and 6-month follow-up). School staff (e.g., principals) will complete a questionnaire assessing the school's capacity to promote healthy behaviors. This includes food and beverage availability, opportunities for physical activity, school health policies, and implementation of health promotion initiatives.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Students from classes participating in the "High Five!" program | Experimental | Behavioral: High FiveHigh Five! |
| Students from classes not participating in the "High Five!" program | No intervention | –school practice as usual |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Primary schools (public, private, general, inclusive) being a student at a school/class taking part in the study
Key exclusion criteria (1 listed)
- Special schools lack of parental consent for the child to participate in the program lack of child's oral consent to participat
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High FiveThe "High Five!"program is based on the Life course theory and family-individual-school (FIS) model. Students are the main target groups of the program, and parents cooperate with the school to enhance the effects of the intervention. Activities addressed to students include the implementation of 6 scenarios, concerning health-related issues, carried out in accordance with detailed scenarios by trained teacher and school nurse. Parents support th program by performing special home tasks together with the child. | Behavioural | Students from classes participating in the "High Five!" program |
Primary outcome
Change from baseline in the BMI z-score at 6 month
Time frame: From enrollment to the end of the follow-up at 6 month
2 secondary outcomes
Change from Baseline in the percentage of students with values indicating increased Systolic Blood Pressure at 6 Months
Time frame: From enrollment to the end of the follow-up at 6 month
Change from Baseline in the percentage of students with values indicating increased Diastolic Blood Pressure at 6 Months
Time frame: From enrollment to the end of the follow-up at 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Background: PubMed 25891054Cao ZJ, Wang SM, Chen Y. A randomized trial of multiple interventions for childhood obesity in China. Am J Prev Med. 2015 May;48(5):552-60. doi: 10.1016/j.amepre.2014.12.014.
- Background: PubMed 25893796Wang Y, Cai L, Wu Y, Wilson RF, Weston C, Fawole O, Bleich SN, Cheskin LJ, Showell NN, Lau BD, Chiu DT, Zhang A, Segal J. What childhood obesity prevention programmes work? A systematic review and meta-analysis. Obes Rev. 2015 Jul;16(7):547-65. doi: 10.1111/obr.12277. Epub 2015 Apr 20.
- Background: PubMed 20054224Telama R. Tracking of physical activity from childhood to adulthood: a review. Obes Facts. 2009;2(3):187-95. doi: 10.1159/000222244. Epub 2009 Jun 12.
- Background: PubMed 36545748Smit MS, Boelens M, Molenberg FJM, Raat H, Jansen W. The long-term effects of primary school-based obesity prevention interventions in children: A systematic review and meta-analysis. Pediatr Obes. 2023 Mar;18(3):e12997. doi: 10.1111/ijpo.12997. Epub 2022 Dec 21.
- Background: PubMed 30266216Sluggett L, Wagner SL, Harris RL. Sleep Duration and Obesity in Children and Adolescents. Can J Diabetes. 2019 Mar;43(2):146-152. doi: 10.1016/j.jcjd.2018.06.006. Epub 2018 Jul 4.
- Background: PubMed 26696565Simmonds M, Llewellyn A, Owen CG, Woolacott N. Predicting adult obesity from childhood obesity: a systematic review and meta-analysis. Obes Rev. 2016 Feb;17(2):95-107. doi: 10.1111/obr.12334. Epub 2015 Dec 23.
- Background: PubMed 35362512Rousham EK, Goudet S, Markey O, Griffiths P, Boxer B, Carroll C, Petherick ES, Pradeilles R. Unhealthy Food and Beverage Consumption in Children and Risk of Overweight and Obesity: A Systematic Review and Meta-Analysis. Adv Nutr. 2022 Oct 2;13(5):1669-1696. doi: 10.1093/advances/nmac032.
- Background: PubMed 32370795Lambrinou CP, Androutsos O, Karaglani E, Cardon G, Huys N, Wikstrom K, Kivela J, Ko W, Karuranga E, Tsochev K, Iotova V, Dimova R, De Miguel-Etayo P, M Gonzalez-Gil E, Tamas H, Jancso Z, Liatis S, Makrilakis K, Manios Y; Feel4Diabetes-study group. Effective strategies for childhood obesity prevention via school based, family involved interventions: a critical review for the development of the Feel4Diabetes-study school based component. BMC Endocr Disord. 2020 May 6;20(Suppl 2):52. doi: 10.1186/s12902-020-0526-5.
- Background: PubMed 37140701Kulaga Z, Swiader-Lesniak A, Kotowska A, Litwin M. Population-based references for waist and hip circumferences, waist-to-hip and waist-to-height ratios for children and adolescents, and evaluation of their predictive ability. Eur J Pediatr. 2023 Jul;182(7):3217-3229. doi: 10.1007/s00431-023-05001-4. Epub 2023 May 4.
- Background: PubMed 35248172Jebeile H, Kelly AS, O'Malley G, Baur LA. Obesity in children and adolescents: epidemiology, causes, assessment, and management. Lancet Diabetes Endocrinol. 2022 May;10(5):351-365. doi: 10.1016/S2213-8587(22)00047-X. Epub 2022 Mar 3.
- Background: PubMed 36771470Jakobsen DD, Brader L, Bruun JM. Association between Food, Beverages and Overweight/Obesity in Children and Adolescents-A Systematic Review and Meta-Analysis of Observational Studies. Nutrients. 2023 Feb 2;15(3):764. doi: 10.3390/nu15030764.
- Background: PubMed 32075607Habib-Mourad C, Ghandour LA, Maliha C, Awada N, Dagher M, Hwalla N. Impact of a one-year school-based teacher-implemented nutrition and physical activity intervention: main findings and future recommendations. BMC Public Health. 2020 Feb 19;20(1):256. doi: 10.1186/s12889-020-8351-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Fijałkowska, Professor principal investigator
Institute of Mother and Child
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Five in people with Overweight, Childhood and Obesity Prevention, run by Institute of Mother and Child, Warsaw, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the BMI z-score at 6 month (time frame: From enrollment to the end of the follow-up at 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07357857, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.