The Effect of 1 Year of Multiprofessional Therapy on Obesity

Obesity Clinical Trial

Official title:

Multiprofessional Impact on Body Composition, Central and Peripheric Adiposity, Lipid Profile, Hormonal Regulation, Lung, Sleep and Humor Disorders in Adolescents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01358773
• Other study ID #: #0135/04
• Status: Recruiting
• Phase: Phase 0
• First received: December 3, 2010
• Last updated: June 29, 2016
• Start date: February 2004
• Est. completion date: December 2016

Study information

• Verified date: June 2016
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2016
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 19 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

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.

Locations

Country	Name	City	State
Brazil	CEPE	São Paulo	SP

Sponsors (4)

Lead Sponsor	Collaborator
Ana R. Damaso	Ana Claudia Pelissari Kravchychyn, Raquel Munhoz da Silveira Campos, Sofia Emanuelle Castro

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body composition	The body composition was measured by plethysmography and by densitometry.	six months	Yes
Secondary	visceral and subcutaneous fat were analyzed by ultrasound	The visceral and subcutaneous fat were analyzed by ultrasound	six months	Yes
Secondary	Serum analysis	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	Yes
Secondary	Lung function	The lung function was measured with a spirometer EasyOne® model 2001 (Zurich, CH) according to American Thoracic Society criteria.	six months	Yes
Secondary	Arterial intima-media thickness	The arterial intima-media thickness was measured by High-resolution ultrasound equipment with a 7-14 MHz linear array transducer.	six months	Yes
Secondary	Sleep parameters	The sleep parameters were evaluated by polysomnography and specific questionnaires.	six months	Yes

External Links

•   CEPE