The Effect of 1 Year of Multiprofessional Therapy on Obesity

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Federal University of São Paulo
Sponsor:
Collaborators:
Raquel Munhoz da Silveira Campos
Sofia Emanuelle Castro
Ana Claudia Pelissari Kravchychyn
Information provided by (Responsible Party):
Ana R. Damaso, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01358773
First received: December 3, 2010
Last updated: June 29, 2016
Last verified: June 2016

December 3, 2010
June 29, 2016
February 2004
December 2004   (final data collection date for primary outcome measure)
Body composition [ Time Frame: six months ] [ Designated as safety issue: Yes ]
The body composition was measured by plethysmography and by densitometry.
Same as current
Complete list of historical versions of study NCT01358773 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
The Effect of 1 Year of Multiprofessional Therapy on Obesity
Multiprofessional Impact on Body Composition, Central and Peripheric Adiposity, Lipid Profile, Hormonal Regulation, Lung, Sleep and Humor Disorders in Adolescents
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.
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.
Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
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
Lifestyle counseling
Obese adolescents are encouraged to improve their lifestyle
Intervention: Other: multidisciplinary intervention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2016
December 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • present obesity ( BMI > 95th)
  • aged between 15-19 years old
  • be able to practice exercise

Exclusion Criteria:

  • pregnancy
  • use of drugs
  • secondary obesity
Both
15 Years to 19 Years   (Child, Adult)
No
Brazil
 
NCT01358773
#0135/04
Yes
Not Provided
Not Provided
Ana R. Damaso, Federal University of São Paulo
Ana R. Damaso
  • Raquel Munhoz da Silveira Campos
  • Sofia Emanuelle Castro
  • Ana Claudia Pelissari Kravchychyn
Principal Investigator: Ana R Dâmaso, PhD Universidade Federal de São Paulo- UNIFESP - Escola Paulista de Medicina - EPM
Federal University of São Paulo
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP