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The Effect of 1 Year of Multiprofessional Therapy on Obesity

This study is currently recruiting participants.
Verified June 2016 by Ana R. Damaso, Federal University of São Paulo
Sponsor:
ClinicalTrials.gov Identifier:
NCT01358773
First Posted: May 24, 2011
Last Update Posted: June 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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
  Purpose
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.

Condition Intervention Phase
Obesity Other: multidisciplinary intervention Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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

Further study details as provided by Ana R. Damaso, Federal University of São Paulo:

Primary Outcome Measures:
  • Body composition [ Time Frame: six months ]
    The body composition was measured by plethysmography and by densitometry.


Secondary Outcome Measures:
  • visceral and subcutaneous fat were analyzed by ultrasound [ Time Frame: six months ]
    The visceral and subcutaneous fat were analyzed by ultrasound

  • Serum analysis [ Time Frame: six months ]
    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 ]
    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 ]
    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 ]
    The sleep parameters were evaluated by polysomnography and specific questionnaires.


Estimated Enrollment: 150
Study Start Date: February 2004
Estimated Study Completion Date: December 2016
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Lifestyle counseling
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

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01358773


Locations
Brazil
CEPE Recruiting
São Paulo, SP, Brazil, 04023-900
Contact: Ana R Dâmaso, post PhD    ++55 (011) 55720177    ana.damaso@unifesp.br   
Sponsors and Collaborators
Ana R. Damaso
Raquel Munhoz da Silveira Campos
Sofia Emanuelle Castro
Ana Claudia Pelissari Kravchychyn
Investigators
Principal Investigator: Ana R Dâmaso, PhD Universidade Federal de São Paulo- UNIFESP - Escola Paulista de Medicina - EPM
  More Information

Additional Information:
CEPE  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ana R. Damaso, Associated Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01358773     History of Changes
Other Study ID Numbers: #0135/04
First Submitted: December 3, 2010
First Posted: May 24, 2011
Last Update Posted: June 30, 2016
Last Verified: June 2016

Keywords provided by Ana R. Damaso, Federal University of São Paulo:
Obesity
Therapy
Interdisciplinary

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms