The Effect of 1 Year of Multiprofessional Therapy on Obesity
Recruitment status was Recruiting
Obese adolescents are submitted to a multiprofessional weight loss program, which is formed by doctors, nutritionists, physiotherapists, psychologists,and physiologists. The volunteers have intervention 3 times a week during one year, where they practice exercises, have nutrition and psychology counseling, and physiotherapy orientation. Once a month they have an appointment with the doctor. The hypothesis of this study is that a multiprofessional therapy is able to improve anthropometric and biochemical parameters, and also the quality of life of obese adolescents.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multiprofessional Impact on Body Composition, Central and Peripheric Adiposity, Lipid Profile, Hormonal Regulation, Lung, Sleep and Humor Disorders in Adolescents|
- Body composition [ Time Frame: six months ] [ Designated as safety issue: Yes ]The body composition was measured by plethysmography and by densitometry.
- visceral and subcutaneous fat were analyzed by ultrasound [ Time Frame: six months ] [ Designated as safety issue: Yes ]The visceral and subcutaneous fat were analyzed by ultrasound
- Serum analysis [ Time Frame: six months ] [ Designated as safety issue: Yes ]The serum analysis was done by blood samples that were collected at the outpatient clinic around 8 a.m. after an overnight fast by a skilled and qualified technician.
- Lung function [ Time Frame: six months ] [ Designated as safety issue: Yes ]The lung function was measured with a spirometer EasyOne® model 2001 (Zurich, CH) according to American Thoracic Society criteria.
- Arterial intima-media thickness [ Time Frame: six months ] [ Designated as safety issue: Yes ]The arterial intima-media thickness was measured by High-resolution ultrasound equipment with a 7-14 MHz linear array transducer.
- Sleep parameters [ Time Frame: six months ] [ Designated as safety issue: Yes ]The sleep parameters were evaluated by polysomnography and specific questionnaires.
|Study Start Date:||February 2004|
|Estimated Study Completion Date:||December 2011|
|Primary Completion Date:||December 2004 (Final data collection date for primary outcome measure)|
Obese adolescents are encouraged to improve their lifestyle
Other: multidisciplinary intervention
Comparison of the polysomnography results, blood collection parameters, resting metabolic rate values, body composition variables, carotid artery thickness values, abdominal and subcutaneous fat and lung function variables baseline, middle and at the end of the one year of interdisciplinary weight loss program combined exercise training with physiotherapy, clinical, nutritional and psychological therapies.
Other Name: Interdisciplinary therapy
The volunteers are submitted to 10 exams (electrocardiogram, polysomnography, blood collection, body composition, rest metabolic rate, DXA, abdominal and carotid ultrasonography, lung function evaluation, ergospirometric test) 3 times a year (baseline, middle and at the end of the year). They also answer nutrition, sleep and psychology questionnaires.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358773
|São Paulo, SP, Brazil, 04023-900|
|Contact: Ana R Dâmaso, post PhD ++55 (011) 55720177 email@example.com|
|Principal Investigator:||Ana R Dâmaso, PhD||Universidade Federal de São Paulo- UNIFESP - Escola Paulista de Medicina - EPM|