AzTrials
AzTrials

ObesityEarly Phase 1NCT01358773

The Effect of 1 Year of Multiprofessional Therapy on Obesity

A Early Phase 1 study testing multidisciplinary intervention in people with Obesity, run by Ana R. Damaso at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 15 to 19 years
Conditions the study is for
Obesity
What is being tested?
multidisciplinary intervention
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteBrazil
Study dates
Feb 2004to Dec 2016
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 19 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • pregnancy
  • use of drugs
  • secondary obesity

Trial locations and contacts

1 site in 1 country.

Brazil1 site, 1 recruiting

  • CEPE

    São Paulo, São Paulo, 04023-900

    Ana R Dâmaso, post PhD, ++55 (011) 55720177, ana.damaso@unifesp.br

    Recruiting

Other trials in Brazil

About this study

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

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.

Read the 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.

Conditions
Obesity
Being tested
multidisciplinary intervention
Keywords
Obesity, Therapy, Interdisciplinary
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • multidisciplinary interventionOther

    Also called Interdisciplinary therapy

    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.

Study groups in NCT01358773
Study groupRoleWhat they receive
Lifestyle counselingOtherObese adolescents are encouraged to improve their lifestyle
Receives: Other: multidisciplinary intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body composition

    The body composition was measured by plethysmography and by densitometry.

    Measured: six months

Secondary outcomes (5)

  1. visceral and subcutaneous fat were analyzed by ultrasound

    The visceral and subcutaneous fat were analyzed by ultrasound

    Measured: six months

  2. 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.

    Measured: six months

  3. Lung function

    The lung function was measured with a spirometer EasyOne® model 2001 (Zurich, CH) according to American Thoracic Society criteria.

    Measured: six months

  4. Arterial intima-media thickness

    The arterial intima-media thickness was measured by High-resolution ultrasound equipment with a 7-14 MHz linear array transducer.

    Measured: six months

  5. Sleep parameters

    The sleep parameters were evaluated by polysomnography and specific questionnaires.

    Measured: six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2011 (estimated)
  2. Study startFeb 2004
  3. Primary completionDec 2004
  4. Study completionDec 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01358773
Sponsor's protocol ID
#0135/04
Status last verified
Jun 2016
First submitted
3 Dec 2010
Last updated
30 Jun 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 32008915

  • 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.

    PubMed 25296762

  • 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.

    PubMed 24381750

  • 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.

    PubMed 22932160

  • 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.

    PubMed 22038064

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing multidisciplinary intervention in people with Obesity, run by Ana R. Damaso at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body composition (time frame: six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01358773, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in