The Effect of 1 Year of Multiprofessional Therapy on Obesity

Early Phase 1

• Conditions: Obesity
• Interventions: Other: multidisciplinary intervention

• Registration Number: NCT01358773
• Lead Sponsor: Ana R. Damaso

Brief Summary

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.

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 Timeline

• Study Start: 2004-02
• Primary Completion: 2004-12
• Study First Submitted: 2010-12-03
• Study First Submitted QC: 2011-05-23
• Study First Posted: 2011-05-24
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-29
• Last Update Posted: 2016-06-30
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lifestyle counseling	multidisciplinary intervention	Obese adolescents are encouraged to improve their lifestyle

Primary Outcome Measures

Name	Time	Method
Body composition	six months	The body composition was measured by plethysmography and by densitometry.

Secondary Outcome Measures

Name	Time	Method
visceral and subcutaneous fat were analyzed by ultrasound	six months	The visceral and subcutaneous fat were analyzed by ultrasound
Serum analysis	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.
Sleep parameters	six months	The sleep parameters were evaluated by polysomnography and specific questionnaires.
Lung function	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	six months	The arterial intima-media thickness was measured by High-resolution ultrasound equipment with a 7-14 MHz linear array transducer.

Trial Locations

Locations (1)

CEPE; 🇧🇷 São Paulo, SP, Brazil