The Effect of 1 Year of Multiprofessional Therapy on Obesity
Primary Purpose
Obesity
Status
Unknown status
Phase
Early Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
multidisciplinary intervention
Sponsored by

About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Therapy, Interdisciplinary
Eligibility 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
Sites / Locations
- CEPERecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Lifestyle counseling
Arm Description
Obese adolescents are encouraged to improve their lifestyle
Outcomes
Primary Outcome Measures
Body composition
The body composition was measured by plethysmography and by densitometry.
Secondary Outcome Measures
visceral and subcutaneous fat were analyzed by ultrasound
The visceral and subcutaneous fat were analyzed by ultrasound
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.
Lung function
The lung function was measured with a spirometer EasyOne® model 2001 (Zurich, CH) according to American Thoracic Society criteria.
Arterial intima-media thickness
The arterial intima-media thickness was measured by High-resolution ultrasound equipment with a 7-14 MHz linear array transducer.
Sleep parameters
The sleep parameters were evaluated by polysomnography and specific questionnaires.
Full Information
NCT ID
NCT01358773
First Posted
December 3, 2010
Last Updated
June 29, 2016
Sponsor
Ana R. Damaso
Collaborators
Raquel Munhoz da Silveira Campos, Sofia Emanuelle Castro, Ana Claudia Pelissari Kravchychyn
1. Study Identification
Unique Protocol Identification Number
NCT01358773
Brief Title
The Effect of 1 Year of Multiprofessional Therapy on Obesity
Official Title
Multiprofessional Impact on Body Composition, Central and Peripheric Adiposity, Lipid Profile, Hormonal Regulation, Lung, Sleep and Humor Disorders in Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2004 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ana R. Damaso
Collaborators
Raquel Munhoz da Silveira Campos, Sofia Emanuelle Castro, Ana Claudia Pelissari Kravchychyn
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Therapy, Interdisciplinary
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle counseling
Arm Type
Other
Arm Description
Obese adolescents are encouraged to improve their lifestyle
Intervention Type
Other
Intervention Name(s)
multidisciplinary intervention
Other Intervention Name(s)
Interdisciplinary therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body composition
Description
The body composition was measured by plethysmography and by densitometry.
Time Frame
six months
Secondary Outcome Measure Information:
Title
visceral and subcutaneous fat were analyzed by ultrasound
Description
The visceral and subcutaneous fat were analyzed by ultrasound
Time Frame
six months
Title
Serum analysis
Description
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.
Time Frame
six months
Title
Lung function
Description
The lung function was measured with a spirometer EasyOne® model 2001 (Zurich, CH) according to American Thoracic Society criteria.
Time Frame
six months
Title
Arterial intima-media thickness
Description
The arterial intima-media thickness was measured by High-resolution ultrasound equipment with a 7-14 MHz linear array transducer.
Time Frame
six months
Title
Sleep parameters
Description
The sleep parameters were evaluated by polysomnography and specific questionnaires.
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana R Dâmaso, PhD
Organizational Affiliation
Universidade Federal de São Paulo- UNIFESP - Escola Paulista de Medicina - EPM
Official's Role
Principal Investigator
Facility Information:
Facility Name
CEPE
City
São Paulo
State/Province
SP
ZIP/Postal Code
04023-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana R Dâmaso, post PhD
Phone
++55 (011) 55720177
Email
ana.damaso@unifesp.br
12. IPD Sharing Statement
Citations:
PubMed Identifier
32008915
Citation
Roche J, Corgosinho FC, Damaso AR, Isacco L, Miguet M, Fillon A, Guyon A, Moreira GA, Pradella-Hallinan M, Tufik S, Tulio de Mello M, Gillet V, Pereira B, Duclos M, Boirie Y, Masurier J, Franco P, Thivel D, Mougin F. Sleep-disordered breathing in adolescents with obesity: When does it start to affect cardiometabolic health? Nutr Metab Cardiovasc Dis. 2020 Apr 12;30(4):683-693. doi: 10.1016/j.numecd.2019.12.003. Epub 2019 Dec 16.
Results Reference
derived
PubMed Identifier
25296762
Citation
Masquio DC, de Piano A, Campos RM, Sanches PL, Carnier J, Corgosinho FC, Netto BD, Carvalho-Ferreira JP, Oyama LM, Oller do Nascimento CM, Tock L, de Mello MT, Tufik S, Damaso AR. Reduction in saturated fat intake improves cardiovascular risks in obese adolescents during interdisciplinary therapy. Int J Clin Pract. 2015 May;69(5):560-70. doi: 10.1111/ijcp.12573. Epub 2014 Oct 9.
Results Reference
derived
PubMed Identifier
24381750
Citation
Grotti Clemente AP, Molin Netto BD, Ganen Ad, Tock L, Arisa Caranti D, de Mello MT, Tufik S, Damaso AR. Cut-Off Values of Visceral Adiposity to Predict NAFLD in Brazilian Obese Adolescents. J Nutr Metab. 2013;2013:724781. doi: 10.1155/2013/724781. Epub 2013 Dec 7.
Results Reference
derived
PubMed Identifier
22932160
Citation
de Piano A, de Mello MT, Sanches Pde L, da Silva PL, Campos RM, Carnier J, Corgosinho F, Foschini D, Masquio DL, Tock L, Oyama LM, do Nascimento CM, Tufik S, Damaso AR. Long-term effects of aerobic plus resistance training on the adipokines and neuropeptides in nonalcoholic fatty liver disease obese adolescents. Eur J Gastroenterol Hepatol. 2012 Nov;24(11):1313-24. doi: 10.1097/MEG.0b013e32835793ac.
Results Reference
derived
PubMed Identifier
22038064
Citation
Corgosinho FC, de Piano A, Sanches PL, Campos RM, Silva PL, Carnier J, Oyama LM, Tock L, Tufik S, de Mello MT, Damaso AR. The role of PAI-1 and adiponectin on the inflammatory state and energy balance in obese adolescents with metabolic syndrome. Inflammation. 2012 Jun;35(3):944-51. doi: 10.1007/s10753-011-9397-2.
Results Reference
derived
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The Effect of 1 Year of Multiprofessional Therapy on Obesity
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