Physical Activity and Nutritional Education as School-based Interventions to Control Obesity in Children and Adolescents

NCT ID: NCT00985972

Last Updated: 2014-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

41634 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2013-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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:

1. 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%)
2. 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%)
3. 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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

OVERWEIGHT OBESITY

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

Groups of school intervention that involves a combination of the physical activity and nutrition education in subjects 6 to 18 years of age

Physical Activity and Nutrition Education

Intervention Type BEHAVIORAL

School-based interventions involving Physical Activity or/and Nutrition Education.

Control

Groups included in the same school communities that serve as reference for individuals involved in intervention.

Physical Activity and Nutrition Education

Intervention Type BEHAVIORAL

School-based interventions involving Physical Activity or/and Nutrition Education.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Physical Activity and Nutrition Education

School-based interventions involving Physical Activity or/and Nutrition Education.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Paulo Henrique de Araujo Guerra

DSc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Moacyr MR Nobre, PhD

Role: PRINCIPAL_INVESTIGATOR

University of São Paulo, Faculty of Medicine, Heart Institute (InCor), Clinical Epidemiology Unit

Paulo Henrique A Guerra, DSc

Role: PRINCIPAL_INVESTIGATOR

University of São Paulo, Faculty of Medicine, Heart Institute (InCor), Clinical Epidemiology Unit

Jonas A Silveira, MSc

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo, Department of Pediatrics

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Heart Institute, General Hospital of Faculty of Medicine of University of Sao Paulo (InCor HCFMUSP)

São Paulo, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 22012577 (View on PubMed)

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. doi: 10.1016/j.ypmed.2013.01.011. Epub 2013 Jan 29.

Reference Type RESULT
PMID: 23370048 (View on PubMed)

Guerra 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.

Reference Type RESULT
PMID: 24141844 (View on PubMed)

Guerra 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.

Reference Type RESULT
PMID: 24440161 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PANE0575-08

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sports to Prevent Obesity: Feasibility and Pilot RCT
NCT00186173 COMPLETED PHASE1/PHASE2