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临床试验/NCT03222713
NCT03222713Unknown不适用

School-based Program of Promotion of Self-regulation for Healthy Eating and Oral Health: Study in the Context of the School Health Program in Brazil

Federal University of Health Science of Porto Alegre1 个研究点 分布在 1 个国家目标入组 429 人开始时间: 2015年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
429
试验地点
1
主要终点
Self-regulation skills for healthy eating and oral health

研究概览

简要总结

The Health and Education Ministries of Brazil launched the Health in School Program - PSE - in 2007. The purpose of the PSE is twofold: articulate the actions of the education and health systems to identify risk factors and prevent them; and promote the education for health in the public elementary school system. In the health field, the self-regulation (SR) construct can contribute to the understanding of life habits which can affect the improvement of individuals' health. This study aims to present a school-based program, Promotion of Self-Regulation in Health (SRH), which adds the self-regulation approach to the topics of healthy eating and oral health of the PSE for elementary school. A study of a randomized clinical trial enrolling the 5th grade students of public elementary schools from the south of Brazil is presented. The study has two phases. In Phase 1, teachers and health professionals will participate in a training program on SRH, and in Phase 2, they will conduct an intervention in class: Promotion of SRH. The participants were randomly assigned into three groups: Condition I followed the PSE program, Condition II group followed the PSE and the SRH program, and the control group did not enroll in either of the health promotion programs. For the evaluation of the study, the following measures and instruments were applied: Body Mass Index (BMI), Simplified Oral Hygiene Index (OHI-S), Previous Day Food Questionnaire (PFDQ), Declarative Knowledge for Health Instrument, Food Preference Instrument, Student´s Attitudes and Perceptions and Parents Perceptions and Influences on the Health Instrument, Food Availability and Oral Health Instrument, Self-Regulation for Health Scale, Self-Efficacy for Health Scale. Students in the three groups will be assessed five times throughout the year: before the beginning of the intervention program, three months into intervention, six months into intervention, at the end of the intervention, and, finally, six months post intervention to check for the impact of the program on children health.

研究设计

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

入排标准

年龄范围
9 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Teachers must teach a 5th grade class in a public elementary school
  • Health professionals must be working in a primary care unit;
  • Students must be enrolled in the 5th grade in a public elementary school;
  • Parents/guardians: must be responsible for a child enrolled in a 5th grade class in a public elementary school
  • All participants must be volunteers and must sign the Free and Informed Consent Term or Term of Assent (parents / guardians and students);

排除标准

  • Potential participants who do not meet all the inclusion criteria, including 5th grade students with special educational needs that limit their cognitive autonomy, will be excluded from the study

结局指标

主要结局

Self-regulation skills for healthy eating and oral health

时间窗: 3 years

Development of self-regulatory competencies for healthier eating and oral health in childhood. These variables wiil be evaluated through Self-Regulation for Health Scale.

Self-efficacy perception for healthy eating and oral health

时间窗: 3 years

Develop increased self-efficacy perception for healthy eating and oral health care. These variables wiil be evaluated through Self-efficacy for Health Scale.

Declarative Knowledge for Health

时间窗: 3 years

Questions for evaluate children knowledge have about healthy eating and oral health. Will be evaluated the numbers of correct answer. These variable These variable wiil be evaluated through Declarative Knowledge for Health Instrument.

次要结局

  • Body Mass Index(3 years)
  • Simplified Oral Hygiene Index - OHI-S(3 years)
  • Food consumption information(3 years)

研究者

发起方
Federal University of Health Science of Porto Alegre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cleidilene Ramos Magalhães

Professor, Project Coordinator Cleidilene Ramos Magalhães

Federal University of Health Science of Porto Alegre

研究点 (1)

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