CClinicalTrials.gg
Status unknownNCT03222713SRHUpdated Jul 19, 2017

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

An interventional study of Program Self-regulation in health in Self-regulation in Health, sponsored by Federal University of Health Science of Porto Alegre. Status unknown at 1 site in Brazil. Open to participants aged 9 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-19.

Sponsored by Federal University of Health Science of Porto Alegre · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Jul 2017), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Jun 2015, registered May 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
429
Allocation
Randomized
Ages
9 Years to 13 Years
Sex
All
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Study 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.

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Conditions studied

  • Self-regulation in Health
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In context

Lead sponsor

Federal University of Health Science of Porto Alegre is the lead sponsor of 118 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
9 Years to 13 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
429 participants (actual)

Interventions

  • OtherProgram 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.

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What researchers measure

Primary outcomes

  1. Self-regulation skills for healthy eating and oral health

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

    Time frame: 3 years

  2. Self-efficacy perception for healthy eating and oral health

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

    Time frame: 3 years

  3. Declarative Knowledge for Health

    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.

    Time frame: 3 years

Secondary outcomes

  1. Body Mass Index

    Numbers of students with Index of overweight, obesity and thinness in the study population. These measure will be evaluated trough BMI.

    Time frame: 3 years

  2. Simplified Oral Hygiene Index - OHI-S

    Numbers and classification of Index of oral hygiene (good, regular and poor), Identified by the presence of dental plaque in the study population.

    Time frame: 3 years

  3. Food consumption information

    Seeks information from schoolchildren about the food they consumed on the day prior. will be evaluated the food group consumed in each meals on three days of week. These variable will evaluated by Previous Day Food Questionnaire .

    Time frame: 3 years

07

Study locations

1 site
  • Cleidilene Ramos Magalhaes
    Porto Alegre, Rio Grande do Sul, Brazil
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03222713
Lead sponsor
Federal University of Health Science of Porto Alegre
Responsible party
Cleidilene Ramos Magalhães (Professor, Project Coordinator Cleidilene Ramos Magalhães, Federal University of Health Science of Porto Alegre) — Principal investigator
First posted
Jul 19, 2017
Start date
Jun 1, 2015
Primary completion
Jun 1, 2016
Completion
Jan 1, 2018 (estimated)
Last update
Jul 19, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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