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

NCT07357857 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 659

Last updated 2026-01-30

No results posted yet for this study

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

Interventions

BEHAVIORAL

High Five

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.

Sponsors & Collaborators

  • Ministry of Health, Poland

    collaborator OTHER_GOV

  • Institute of Mother and Child, Warsaw, Poland

    lead OTHER

Principal Investigators

  • Anna Fijałkowska, Professor · Institute of Mother and Child

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-23
Primary Completion
2025-11-28
Completion
2025-11-28

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07357857 on ClinicalTrials.gov