Self-regulation in HealthSRHNCT03222713
School-based Program Promotion of Self-regulation in Eating Healthy and Oral Health
A study testing Program Self-regulation in health in people with Self-regulation in Health, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Self-regulation in Health
- What is being tested?
- Program Self-regulation in health
- Type of treatment
- Pill or oral medicine
- How many people
- 429 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2015to 1 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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);
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Program Self-regulation in health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program Self-regulation in healthOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
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.
Measured: 3 years
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.
Measured: 3 years
Secondary outcomes (3)
Body Mass Index
Numbers of students with Index of overweight, obesity and thinness in the study population. These measure will be evaluated trough BMI.
Measured: 3 years
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.
Measured: 3 years
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 .
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start1 Jun 2015
- Primary completion1 Jun 2016
- Study completion1 Jan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-regulation in HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 429 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cleidilene Ramos Magalhães, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222713
- Sponsor's protocol ID
- Self-regulation in health
- Acronym
- SRH
- Status last verified
- Jul 2017
- First submitted
- 17 May 2017
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03222713
- Acronym / sponsor ID
- SRH / Self-regulation in health
- Conditions
- Self-regulation in Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 429 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 1 Jan 2018 (estimated)
- First posted
- 19 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- 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
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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);
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Program Self-regulation in healthThe 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. | Other | – |
Primary outcome
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.
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.
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 secondary outcomes
Body Mass Index
Time frame: 3 years
Simplified Oral Hygiene Index - OHI-S
Time frame: 3 years
Food consumption information
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Program Self-regulation in health in people with Self-regulation in Health, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-regulation skills for healthy eating and oral health (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.