The Effect of 1 Year of Multiprofessional Therapy on Obesity

June 29, 2016 updated by: Ana R. Damaso

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 04023-900
        • Recruiting
        • CEPE
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • Interdisciplinary therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: six months
The body composition was measured by plethysmography and by densitometry.
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visceral and subcutaneous fat were analyzed by ultrasound
Time Frame: six months
The visceral and subcutaneous fat were analyzed by ultrasound
six months
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.
six months
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.
six months
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.
six months
Sleep parameters
Time Frame: six months
The sleep parameters were evaluated by polysomnography and specific questionnaires.
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ana R. Damaso

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

December 1, 2004

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

December 3, 2010

First Submitted That Met QC Criteria

May 23, 2011

First Posted (Estimate)

May 24, 2011

Study Record Updates

Last Update Posted (Estimate)

June 30, 2016

Last Update Submitted That Met QC Criteria

June 29, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #0135/04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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