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临床试验/NCT07357857
NCT07357857已完成不适用

Effectiveness of the "High Five!" Program for Reducing the Risk of Overweight and Obesity in Early School-age Children

Institute of Mother and Child, Warsaw, Poland1 个研究点 分布在 1 个国家目标入组 659 人开始时间: 2025年4月23日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
659
试验地点
1
主要终点
Change from baseline in the BMI z-score at 6 month

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
6 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

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

Experimental

High Five!

干预措施: High Five (Behavioral)

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

No Intervention

school practice as usual

结局指标

主要结局

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

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

次要结局

  • 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)

研究者

发起方
Institute of Mother and Child, Warsaw, Poland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Anna Fijałkowska

prof. dr hab. med. i n. o zdr.

Institute of Mother and Child, Warsaw, Poland

研究点 (1)

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