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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00985972
Other study ID # PANE0575-08
Secondary ID
Status Completed
Phase N/A
First received September 23, 2009
Last updated March 14, 2014
Start date June 2009
Est. completion date September 2013

Study information

Verified date March 2014
Source University of Sao Paulo General Hospital
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Observational

Clinical 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. 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%)


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.


Recruitment information / eligibility

Status Completed
Enrollment 41634
Est. completion date September 2013
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Years to 18 Years
Eligibility 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.

Study Design

Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Brazil Heart Institute, General Hospital of Faculty of Medicine of University of Sao Paulo (InCor HCFMUSP) Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

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 — View Citation

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. Review. — View Citation

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: d — View Citation

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.ypm — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Body Mass Index (BMI) 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. Yes
Secondary Body Weight requirement for pre and post-intervention assessments Yes
Secondary Blood Pressure Systolic and Diastolic blood pressure requirement for pre and post-intervention assessments Yes
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