Clinical trial NCT03222713: School-based Program Promotion of Self-regulation in Eating Healthy and Oral Health
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Self-regulation in Health
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2017-07-19
Enrollment: 429
Sex: ALL
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants were randomly assigned into three groups: Condition I followed the health school program (PSE), Condition II group followed the PSE and the Self-regulation Health - SRH program, and the control group did not enroll in either of the health promotion programs
Primary purpose: OTHER

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.


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);

Exclusion Criteria:

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

Primary outcomes:
measure: Self-regulation skills for healthy eating and oral health
timeFrame: 3 years
measure: Self-efficacy perception for healthy eating and oral health
timeFrame: 3 years
measure: Declarative Knowledge for Health
timeFrame: 3 years
Secondary outcomes:
measure: Body Mass Index
timeFrame: 3 years
measure: Simplified Oral Hygiene Index - OHI-S
timeFrame: 3 years
measure: Food consumption information
timeFrame: 3 years
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Cleidilene Ramos Magalhaes
state: Rio Grande do Sul
Study officials:
References: