School-based Program Promotion of Self-regulation in Eating Healthy and Oral Health

NCT ID: NCT03222713

Last Updated: 2017-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 429 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-01
• Study Completion Date: 2018-01-01

Brief Summary

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.

Conditions

Self-regulation in Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Interventions

Program Self-regulation in health

The intervention program with children will be run by teachers and health professionals (Condition Group II) in 50-minute biweekly sessions which will take place in class in school year. During these sessions, the children will complete the following tasks: the reading of the chapters of Yellow Trials and Tribulations (one chapter per week) and the discussions and activities related to the topics of healthy eating and oral health.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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);

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Cleidilene Ramos Magalhães

Professor, Project Coordinator Cleidilene Ramos Magalhães

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cleidilene Ramos Magalhaes

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

Self-regulation in health

Identifier Type: -

Identifier Source: org_study_id