NCT01358773

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for early_phase_1 obesity

Timeline
Completed

Started Feb 2004

Longer than P75 for early_phase_1 obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2010

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 24, 2011

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 30, 2016

Status Verified

June 1, 2016

Enrollment Period

10 months

First QC Date

December 3, 2010

Last Update Submit

June 29, 2016

Conditions

Keywords

ObesityTherapyInterdisciplinary

Outcome Measures

Primary Outcomes (1)

  • Body composition

    The body composition was measured by plethysmography and by densitometry.

    six months

Secondary Outcomes (5)

  • visceral and subcutaneous fat were analyzed by ultrasound

    six months

  • Serum analysis

    six months

  • Lung function

    six months

  • Arterial intima-media thickness

    six months

  • Sleep parameters

    six months

Study Arms (1)

Lifestyle counseling

OTHER

Obese adolescents are encouraged to improve their lifestyle

Other: multidisciplinary intervention

Interventions

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.

Also known as: Interdisciplinary therapy
Lifestyle counseling

Eligibility Criteria

Age15 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • present obesity ( BMI \> 95th)
  • aged between 15-19 years old
  • be able to practice exercise

You may not qualify if:

  • pregnancy
  • use of drugs
  • secondary obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CEPE

São Paulo, São Paulo, 04023-900, Brazil

RECRUITING

Related Publications (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ana R Dâmaso, PhD

    Universidade Federal de São Paulo- UNIFESP - Escola Paulista de Medicina - EPM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

December 3, 2010

First Posted

May 24, 2011

Study Start

February 1, 2004

Primary Completion

December 1, 2004

Study Completion

December 1, 2016

Last Updated

June 30, 2016

Record last verified: 2016-06

Locations