OVERWEIGHTPANENCT00985972
Physical Activity and Nutritional Education as School-based Interventions to Control Obesity in Children and Adolescents
An observational study of OVERWEIGHT and OBESITY, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The aim of this study focuses on obtaining accurate information on the effectiveness of interventions involving physical activity and/or nutrition education developed in the school environment. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- OVERWEIGHT, OBESITY
- What is being tested?
- Physical Activity and Nutrition Education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 41,634 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2009to Sep 2013
- Phase
- Observational
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children and adolescents aged 6 to 18 years of age included in the school environment, regardless of their ethnicity, social condition and weight range.
Who may be able to join
- Randomized clinical / community trials whose main objective is the focus on control and / or reduction of body weight of the participants, conducted by a program developed in the scholar environment that promotes the practice of physical activity and healthy eating through nutrition education.
- Studies that include participants aged 6 to 18 years of age, regardless of the range of weight.
- There is no restriction ethnic, social, gender, nutritional status and physical fitness.
- There is no limitation of language for critical evaluation of studies.
Who cannot join
- Studies making use of pharmacological agents
- Studies with participants who suffer from diseases, or specific clinical conditions, except obesity
- Studies not conducted in the school environment
- The duplicated data will be excluded.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Heart Institute, General Hospital of Faculty of Medicine of University of Sao Paulo (InCor HCFMUSP)
São Paulo, São Paulo
About this study
Official title: Physical Activity and Nutritional Education as School-based Interventions to Control Overweight in Children and Adolescents: a Systematic Review (Project PANE)
The aim of this study focuses on obtaining accurate information on the effectiveness of interventions involving physical activity and/or nutrition education developed in the school environment. This study is intended to assist in future assembly and development of effective school practices related to preventing and reducing levels of overweight in children and adolescents.
Updated data from the systematic review:
Read more
5,899 studies were retrieved in 14 databases (Assia, Central Cochrane, CINAHL, EMBASE, ERIC, ISI, LILACS, Physical Education Index, PsycINFO, PubMed, Social Care Online, Social Services Abstracts, Sociological Abstracts, SPORTDiscus)
1,228 were excluded as duplicates by Eppi Reviewer
4,678 studies referred for evaluation by title and abstracts (4,671 by systematic searches, 7 by cross-references list)
211 full text papers reviewed by EPHPP and GRADE tools
140 studies with data extracted
Body Mass Index Results:
- Guerra PH, Nobre MRC, Silveira JAC, Taddei JAAC. The effect of school-based physical activity interventions on body mass index: a meta-analysis of randomized trials. Clinics (Sao Paulo). 2013 Sep;68(9):1263-1273 - Isolated Physical Activity interventions: 0.02 (95%CI: -0.13, 0.17; 11 trials; n=4,273; I2=77%)
- Silveira JA, Taddei JA, Guerra PH, Nobre MR. The effect of participation in school-based nutrition education interventions on body mass index: a meta-analysis of randomized controlled community trials. Prev Med. 2013 Mar;56(3-4):237-43 - Isolated Nutrition Education interventions: -0.33 (95%CI: -0.55, -0.11; 8 trials; n=8,491; I2=95%)
- Guerra PH, Nobre MRC, Silveira JAC, Taddei JAAC. School-based physical activity and nutritional education interventions on body mass index: a meta-analysis of randomized community trials - Project PANE (manuscript under review) - Combined Physical Activity and Nutrition Education interventions: -0.03 (-0.09, 0.04; 38 trials; n=28,870; I2=83%) / All interventions included: -0.03 (95%CI: -0.09, 0.03; 55 trials n=41,634; I2=87%)
Read the detailed description
The inordinate increase in the prevalence of overweight and obesity at the international level today is one of the targets of concern the department of public health, and gradually has been the focus of many studies and interventions which emphasize the need for more evidence to clear and effective its prevention and reduction. Obesity can affect the short or long term health of individuals, through problems such as left ventricular hypertrophy in young-adult and atherosclerosis, which is due to the formation of plaques of fat in the arterial wall and may lead to coronary artery disease , cerebrovascular disease and peripheral vascular disease.
The promotion of regular practice of physical activity through physical education school can be an effective way to prevent obesity among children, especially girls. There is an inverse relationship between physical activity and incidence of hypertension. The earlier the entrance to the practice of physical activities, there will be more effective in combating the increase in body mass index (BMI).
Nutrition Education is to extend the knowledge on nutrition and the ability to understand the practices and eating behavior, improving the relationship of the individual in the environment which is introduced, allowing the taking of decisions under the situation presented.
- Conditions
- OVERWEIGHT, OBESITY
- Being tested
- Physical Activity and Nutrition Education
- Keywords
- PHYSICAL ACTIVITY, SCHOOL, NUTRITION, EDUCATION, OVERWEIGHT
- Medical subject headings
- Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity and Nutrition EducationBehavioural
School-based interventions involving Physical Activity or/and Nutrition Education.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Groups of school intervention that involves a combination of the physical activity and nutrition education in subjects 6 to 18 years of age Receives: Behavioral: Physical Activity and Nutrition Education | |
| Control | Groups included in the same school communities that serve as reference for individuals involved in intervention. Receives: Behavioral: Physical Activity and Nutrition Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)
Measured: Assessments results should at least monitor the execution time of the intervention studies, with a minimum of two assessments: pre-and post-intervention. This requirement depends directly on the studies to be extracted in the systematic search.
Secondary outcomes (2)
Body Weight
Measured: requirement for pre and post-intervention assessments
Blood Pressure
Systolic and Diastolic blood pressure
Measured: requirement for pre and post-intervention assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2010
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OVERWEIGHTStudies 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 41,634 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paulo Henrique de Araujo Guerra, University of Sao Paulo General Hospital
- Investigators
- Moacyr MR Nobre, PhD, Principal investigator, University of São Paulo, Faculty of Medicine, Heart Institute (InCor), Clinical Epidemiology UnitPaulo Henrique A Guerra, DSc, Principal investigator, University of São Paulo, Faculty of Medicine, Heart Institute (InCor), Clinical Epidemiology UnitJonas A Silveira, MSc, Principal investigator, Federal University of São Paulo, Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985972
- Sponsor's protocol ID
- PANE0575-08
- Acronym
- PANE
- Status last verified
- Mar 2014
- First submitted
- 23 Sep 2009
- Last updated
- 17 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Silveira JA, Taddei JA, Guerra PH, Nobre MR. Effectiveness of school-based nutrition education interventions to prevent and reduce excessive weight gain in children and adolescents: a systematic review. J Pediatr (Rio J). 2011 Sep-Oct;87(5):382-92. doi: 10.2223/JPED.2123. English, Portuguese.
PubMed 22012577Silveira JA, Taddei JA, Guerra PH, Nobre MR. The effect of participation in school-based nutrition education interventions on body mass index: a meta-analysis of randomized controlled community trials. Prev Med. 2013 Mar;56(3-4):237-43. doi: 10.1016/j.ypmed.2013.01.011. Epub 2013 Jan 29.
PubMed 23370048Guerra PH, Nobre MR, Silveira JA, Taddei JA. The effect of school-based physical activity interventions on body mass index: a meta-analysis of randomized trials. Clinics (Sao Paulo). 2013 Sep;68(9):1263-73. doi: 10.6061/clinics/2013(09)14.
PubMed 24141844Guerra PH, Nobre MR, da Silveira JA, Taddei JA. School-based physical activity and nutritional education interventions on body mass index: a meta-analysis of randomised community trials - project PANE. Prev Med. 2014 Apr;61:81-9. doi: 10.1016/j.ypmed.2014.01.005. Epub 2014 Jan 16.
PubMed 24440161
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Nutritional Education as School-based Interventions to Control Overweight in Children and Adolescents: a Systematic Review (Project PANE)
- ClinicalTrials.gov ID
- NCT00985972
- Acronym / sponsor ID
- PANE / PANE0575-08
- Conditions
- OVERWEIGHT, OBESITY
- Keywords
- PHYSICAL ACTIVITY, SCHOOL, NUTRITION, EDUCATION, OVERWEIGHT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41,634 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 29 Sep 2009 (estimated)
- 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 aim of this study focuses on obtaining accurate information on the effectiveness of interventions involving physical activity and/or nutrition education developed in the school environment. This study is intended to assist in future assembly and development of effective school practices related to preventing and reducing levels of overweight in children and adolescents.
Updated data from the systematic review:
5,899 studies were retrieved in 14 databases (Assia, Central Cochrane, CINAHL, EMBASE, ERIC, ISI, LILACS, Physical Education Index, PsycINFO, PubMed, Social Care Online, Social Services Abstracts, Sociological Abstracts, SPORTDiscus)
1,228 were excluded as duplicates by Eppi Reviewer
4,678 studies referred for evaluation by title and abstracts (4,671 by systematic searches, 7 by cross-references list)
211 full text papers reviewed by EPHPP and GRADE tools
140 studies with data extracted
Body Mass Index Results:
- Guerra PH, Nobre MRC, Silveira JAC, Taddei JAAC. The effect of school-based physical activity interventions on body mass index: a meta-analysis of randomized trials. Clinics (Sao Paulo). 2013 Sep;68(9):1263-1273 - Isolated Physical Activity interventions: 0.02 (95%CI: -0.13, 0.17; 11 trials; n=4,273; I2=77%)
- Silveira JA, Taddei JA, Guerra PH, Nobre MR. The effect of participation in school-based nutrition education interventions on body mass index: a meta-analysis of randomized controlled community trials. Prev Med. 2013 Mar;56(3-4):237-43 - Isolated Nutrition Education interventions: -0.33 (95%CI: -0.55, -0.11; 8 trials; n=8,491; I2=95%)
- Guerra PH, Nobre MRC, Silveira JAC, Taddei JAAC. School-based physical activity and nutritional education interventions on body mass index: a meta-analysis of randomized community trials - Project PANE (manuscript under review) - Combined Physical Activity and Nutrition Education interventions: -0.03 (-0.09, 0.04; 38 trials; n=28,870; I2=83%) / All interventions included: -0.03 (95%CI: -0.09, 0.03; 55 trials n=41,634; I2=87%)
Detailed description
The inordinate increase in the prevalence of overweight and obesity at the international level today is one of the targets of concern the department of public health, and gradually has been the focus of many studies and interventions which emphasize the need for more evidence to clear and effective its prevention and reduction. Obesity can affect the short or long term health of individuals, through problems such as left ventricular hypertrophy in young-adult and atherosclerosis, which is due to the formation of plaques of fat in the arterial wall and may lead to coronary artery disease , cerebrovascular disease and peripheral vascular disease.
The promotion of regular practice of physical activity through physical education school can be an effective way to prevent obesity among children, especially girls. There is an inverse relationship between physical activity and incidence of hypertension. The earlier the entrance to the practice of physical activities, there will be more effective in combating the increase in body mass index (BMI).
Nutrition Education is to extend the knowledge on nutrition and the ability to understand the practices and eating behavior, improving the relationship of the individual in the environment which is introduced, allowing the taking of decisions under the situation presented.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Behavioral: Physical Activity and Nutrition EducationGroups of school intervention that involves a combination of the physical activity and nutrition education in subjects 6 to 18 years of age |
| Control | – | Behavioral: Physical Activity and Nutrition EducationGroups included in the same school communities that serve as reference for individuals involved in intervention. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents aged 6 to 18 years of age included in the school environment, regardless of their ethnicity, social condition and weight range.
Key inclusion criteria (4 listed)
- Randomized clinical / community trials whose main objective is the focus on control and / or reduction of body weight of the participants, conducted by a program developed in the scholar environment that promotes the practice of physical activity and healthy eating through nutrition education.
- Studies that include participants aged 6 to 18 years of age, regardless of the range of weight.
- There is no restriction ethnic, social, gender, nutritional status and physical fitness.
- There is no limitation of language for critical evaluation of studies.
Key exclusion criteria (4 listed)
- Studies making use of pharmacological agents
- Studies with participants who suffer from diseases, or specific clinical conditions, except obesity
- Studies not conducted in the school environment
- The duplicated data will be excluded.
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 |
|---|---|---|
| Physical Activity and Nutrition EducationSchool-based interventions involving Physical Activity or/and Nutrition Education. | Behavioural | Control, Intervention |
Primary outcome
Body Mass Index (BMI)
Time frame: Assessments results should at least monitor the execution time of the intervention studies, with a minimum of two assessments: pre-and post-intervention. This requirement depends directly on the studies to be extracted in the systematic search.
2 secondary outcomes
Body Weight
Time frame: requirement for pre and post-intervention assessments
Blood Pressure
Time frame: requirement for pre and post-intervention assessments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2014.
- Results publication: PubMed 22012577Silveira JA, Taddei JA, Guerra PH, Nobre MR. Effectiveness of school-based nutrition education interventions to prevent and reduce excessive weight gain in children and adolescents: a systematic review. J Pediatr (Rio J). 2011 Sep-Oct;87(5):382-92. doi: 10.2223/JPED.2123. English, Portuguese.
- Results publication: PubMed 23370048Silveira JA, Taddei JA, Guerra PH, Nobre MR. The effect of participation in school-based nutrition education interventions on body mass index: a meta-analysis of randomized controlled community trials. Prev Med. 2013 Mar;56(3-4):237-43. doi: 10.1016/j.ypmed.2013.01.011. Epub 2013 Jan 29.
- Results publication: PubMed 24141844Guerra PH, Nobre MR, Silveira JA, Taddei JA. The effect of school-based physical activity interventions on body mass index: a meta-analysis of randomized trials. Clinics (Sao Paulo). 2013 Sep;68(9):1263-73. doi: 10.6061/clinics/2013(09)14.
- Results publication: PubMed 24440161Guerra PH, Nobre MR, da Silveira JA, Taddei JA. School-based physical activity and nutritional education interventions on body mass index: a meta-analysis of randomised community trials - project PANE. Prev Med. 2014 Apr;61:81-9. doi: 10.1016/j.ypmed.2014.01.005. Epub 2014 Jan 16.
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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.
Moacyr MR Nobre, PhD principal investigator
University of São Paulo, Faculty of Medicine, Heart Institute (InCor), Clinical Epidemiology Unit
Paulo Henrique A Guerra, DSc principal investigator
University of São Paulo, Faculty of Medicine, Heart Institute (InCor), Clinical Epidemiology Unit
Jonas A Silveira, MSc principal investigator
Federal University of São Paulo, Department of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of OVERWEIGHT and OBESITY, run by University of Sao Paulo General Hospital 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 17 Mar 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Body Mass Index (BMI) (time frame: Assessments results should at least monitor the execution time of the intervention studies, with a minimum of two assessments: pre-and post-intervention. This requirement depends directly on the studies to be extracted in the systematic search.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00985972, which also lists 4 linked publications.
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 17 Mar 2014.