High Five! - School-based Prevention of Overweight and Obesity Among 6 to 9 Year Olds

NCT07357857 | Completed

• 1 other identifier: 6/11/85195/NPZ/2021/106/830
• Study Type: interventional
• Target: 659
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Overweight, Childhood; Obesity Prevention; Blood Pressure

Keywords

children; school-based intervention; overweight prevention; non-communicable diseases prevention; health promotion; health education

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the BMI z-score at 6 month

  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

  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

  From enrollment to the end of the follow-up at 6 month

Other Outcomes (33)

• Change from baseline in the percentage of students with emotional and behavioral problems based on PSC-17 scores at 6 months

  From enrollment to the end of the follow-up at 6 month

• Change from Baseline in the score on the Parental Support and Control scale at 6 Months

  From enrollment to the end of the follow-up at 6 month

• Change from baseline in the percentage of students meeting recommendations for daily moderate physical activity (MVPA) after 6 months

  From enrollment to the end of the follow-up at 6 months

Study Arms (2)

Students from classes participating in the "High Five!" program

EXPERIMENTAL

High Five!

Behavioral: High Five

Students from classes not participating in the "High Five!" program

NO INTERVENTION

school practice as usual

Interventions

High Five BEHAVIORAL

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.

Students from classes participating in the "High Five!" program

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Primary schools (public, private, general, inclusive) being a student at a school/class taking part in the study

You may not qualify if:

• Special schools lack of parental consent for the child to participate in the program lack of child's oral consent to participat

Sponsors & Collaborators

• Institute of Mother and Child, Warsaw, Poland: lead
• Ministry of Health, Poland: collaborator

Study Sites (1)

Institute of Mother and Child

Warsaw, 01-211, Poland

Location

Related Publications (15)

• 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.

  PMID: 25891054 BACKGROUND

• Wang 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.

  PMID: 25893796 BACKGROUND

• Telama 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.

  PMID: 20054224 BACKGROUND

• Smit 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.

  PMID: 36545748 BACKGROUND

• Sluggett 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.

  PMID: 30266216 BACKGROUND

• Simmonds 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.

  PMID: 26696565 BACKGROUND

• Rousham 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.

  PMID: 35362512 BACKGROUND

• Lambrinou 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.

  PMID: 32370795 BACKGROUND

• Kulaga 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.

  PMID: 37140701 BACKGROUND

• Jebeile 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.

  PMID: 35248172 BACKGROUND

• Jakobsen 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.

  PMID: 36771470 BACKGROUND

• Habib-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.

  PMID: 32075607 BACKGROUND

• Cockerham 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.

  PMID: 35725145 BACKGROUND

• Calcaterra 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.

  PMID: 36771409 BACKGROUND

• Bornhorst 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.

  PMID: 25924872 BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity; Health Education

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Anna Fijałkowska, Professor

  Institute of Mother and Child

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr hab. med. i n. o zdr.

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 22, 2026
• Study Start: April 23, 2025
• Primary Completion: November 28, 2025
• Study Completion: November 28, 2025
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)