Clinical trial NCT01358773: 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
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Obesity
Keywords: Obesity
Therapy
Interdisciplinary
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Raquel Munhoz da Silveira Campos
name: Sofia Emanuelle Castro
name: Ana Claudia Pelissari Kravchychyn
First posted: 2011-05-24
Enrollment: 150
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Body composition
timeFrame: six months
Secondary outcomes:
measure: visceral and subcutaneous fat were analyzed by ultrasound
timeFrame: six months
measure: Serum analysis
timeFrame: six months
measure: Lung function
timeFrame: six months
measure: Arterial intima-media thickness
timeFrame: six months
measure: Sleep parameters
timeFrame: six months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: CEPE
state: SP
Study officials:
affiliation: Universidade Federal de São Paulo- UNIFESP - Escola Paulista de Medicina - EPM
name: Ana R Dâmaso, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.