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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
  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
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Body composition [ Time Frame: six months ] [ Designated as safety issue: Yes ]
    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 ] [ 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.


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

Ages Eligible for Study:   15 Years to 19 Years   (Child, Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: December 3, 2010
Last Updated: June 29, 2016
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
Obesity
Therapy
Interdisciplinary

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

ClinicalTrials.gov processed this record on September 23, 2016