- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03222713
School-based Program Promotion of Self-regulation in Eating Healthy and Oral Health (SRH)
July 17, 2017 updated by: Cleidilene Ramos Magalhães, Federal University of Health Science of Porto Alegre
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
429
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazil
- Cleidilene Ramos Magalhaes
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 13 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-regulation skills for healthy eating and oral health
Time Frame: 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.
|
3 years
|
Self-efficacy perception for healthy eating and oral health
Time Frame: 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.
|
3 years
|
Declarative Knowledge for Health
Time Frame: 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.
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Mass Index
Time Frame: 3 years
|
Numbers of students with Index of overweight, obesity and thinness in the study population.
These measure will be evaluated trough BMI.
|
3 years
|
Simplified Oral Hygiene Index - OHI-S
Time Frame: 3 years
|
Numbers and classification of Index of oral hygiene (good, regular and poor), Identified by the presence of dental plaque in the study population.
|
3 years
|
Food consumption information
Time Frame: 3 years
|
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 .
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2015
Primary Completion (Actual)
June 1, 2016
Study Completion (Anticipated)
January 1, 2018
Study Registration Dates
First Submitted
May 17, 2017
First Submitted That Met QC Criteria
July 17, 2017
First Posted (Actual)
July 19, 2017
Study Record Updates
Last Update Posted (Actual)
July 19, 2017
Last Update Submitted That Met QC Criteria
July 17, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- Self-regulation in health
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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