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ObesityNCT02573688

Interdisciplinary Intervention in Patients With Obesity and Other Metabolic Diseases

A study testing Interdisciplinary Therapy in people with Obesity, run by Federal University of São Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the research study will be assess the effectiveness of a long-term interdisciplinary lifestyle in many aspects including food intake, psychological symptoms, physical activity habits, energy expenditure, body composition and anthropometric measurements in adults obese. Read more about this study

Who is it for?
Ages 30 to 50 years
Conditions the study is for
Obesity
What is being tested?
Interdisciplinary Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
1 siteBrazil
Study dates
Jan 2017to Aug 2018
Phase
Interventional
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 30 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age from 30 to 50 years and body mass index (BMI) between 30 and 39.9 Kg/m2

Who cannot join

  • Musculoskeletal limitations preventing the practice of physical exercise, other metabolic or endocrine diseases, identified genetic diseases, pregnancy, previous drug utilization and excessive chronic alcohol consumption

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • GEO - Obesity Study Group

    Santos, São Paulo, 11045301

Other trials in Brazil

About this study

Official title: Interdisciplinary Intervention Project - Promotion and Rehabilitation in Patients With Obesity and Other Metabolic Diseases

The aim of the research study will be assess the effectiveness of a long-term interdisciplinary lifestyle in many aspects including food intake, psychological symptoms, physical activity habits, energy expenditure, body composition and anthropometric measurements in adults obese.

Read the detailed description

Participants will be recruited after dissemination of the program in the local media and internet.

They will go through a short interview to evaluate inclusion and exclusion criteria. Thus, all obese adults will be submitted to an interdisciplinary lifestyle modification therapy according the inclusion criteria.

The interdisciplinary therapy will consist of nutritional, physical exercise, psychological and physiotherapy support during the course of one year, according the literature the investigators promote a long term therapy to control obesity and metabolic diseases.

The participants will be evaluated at baseline and after the therapy in accordance with Ethical guidelines.

The main purpose of this therapy is to enhance the quality of life of the participants promoting an active lifestyle and quality of life, adherence a healthy nutritional habits and a healthy weight loss.

Our focus will be on teaching strategies to maintain a healthy life style behaviors after therapy, our protocol is in agreement with public health field in this way.

Conditions
Obesity
Being tested
Interdisciplinary Therapy
Keywords
Obesity, Metabolic Syndrome X, Interdisciplinary Studies
Medical subject headings
Obesity, Metabolic Syndrome

What participants receive

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

  • Interdisciplinary TherapyBehavioural

    Also called Obesity Treatment, Lifestyle Improvement

    The nutrition intervention will consist of group meetings and prescription of individual diets. Participants will have dietary lessons, with information related to the improvement of food consumption and nutritional quality. Exercise program will be focused on improving activity habits, leading to increased energy expenditure. They will undergo training sessions containing aerobic and resistance training. In Psychological program, participants will be monitored in the support group and, if necessary, individual psychological therapy is recommended. The sessions will discuss common psychological aspects commonly associated with obesity (depression, anxiety, stress, family problems, body image, eating disorders and others). The physiotherapy interventions aim to increase functional capacity.

Study groups in NCT02573688
Study groupRoleWhat they receive
Interdisciplinary TherapyExperimentalThe Therapy includes: Physical Exercise (three times week - 180 minutes); Nutrition, Psychology, Physiotherapy (once a week - 60 minutes each one)
Receives: Behavioral: Interdisciplinary Therapy

What is being measured

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

  1. Body Mass

    Body Mass (kg)

    Measured: one year

  2. Physical Activity

    Quadrimensional accelerometer

    Measured: one year

Secondary outcomes (14)

  1. Total Cholesterol.

    Blood lipid fraction (mg/dL) after 12h overnight fasting.

    Measured: one year

  2. High Density Lipoprotein - Cholesterol

    HDL-c; Blood lipid fraction (mg/dL) after 12h overnight fasting.

    Measured: one year

  3. Triglycerides

    Blood lipid fraction (mg/dL) after 12h overnight fasting.

    Measured: one year

  4. Glucose levels.

    Glucose levels (mg/dL) after 12h overnight fasting.

    Measured: one year

  5. Waist circumference

    Anthropometric measure (cm)

    Measured: one year

  6. Blood Pressure

    Systolic and Diastolic Blood pressure (mmHg)

    Measured: one year

  7. Improvement in Quality of Life

    WHO - Quality of life Brief Questionnaire

    Measured: One year

  8. Cardiorespiratory parameters

    Maximal ergometer test. Maximal oxygen uptake.

    Measured: One year

  9. Resting Metabolic Rate

    Indirect calorimetry test (kcal/day)

    Measured: One year

  10. Psychological Parameters - Anxiety

    Anxiety, Beck´s Anxiety Inventory Questionnaire (Score)

    Measured: one year

  11. Psychological Parameters - Depression

    Depression; Beck´s Depression Inventory Questionnaire (Score)

    Measured: one year

  12. Physiotherapy parameters

    Functional capacity - Health Assessment Questionnaire (Score)

    Measured: one year

  13. Nutritional parameters

    Macronutrient, micronutrient and calorie intakes

    Measured: one year

  14. Inflammatory markers

    adipokines status

    Measured: one year

Timeline

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

  1. First posted12 Oct 2015 (estimated)
  2. Study startJan 2017
  3. Primary completionDec 2017
  4. Study completionAug 2018

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
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02573688
Sponsor's protocol ID
LIDM-2014-GEO
Status last verified
Feb 2020
First submitted
2 Oct 2015
Last updated
25 Feb 2020
Results posted
No
Data monitoring committee
No

Publications

  • Jamar G, Pisani LP, Medeiros A, Oyama LM, Masquio DC, Colantonio E, Garcia S, Sanches RB, dos Santos Moraes A, Belote C, Caranti DA. Effect of Fat Intake on the Inflammatory Process and Cardiometabolic Risk in Obesity After Interdisciplinary Therapy. Horm Metab Res. 2016 Feb;48(2):106-11. doi: 10.1055/s-0035-1548871. Epub 2015 Sep 15.

    PubMed 26372897

  • Moraes Ados S, Pisani LP, Corgosinho FC, Carvalho LO, Masquio DC, Jamar G, Sanches RB, Oyama LM, Damaso AR, Belote C, Caranti DA. The role of leptinemia state as a mediator of inflammation in obese adults. Horm Metab Res. 2013 Aug;45(8):605-10. doi: 10.1055/s-0033-1343450. Epub 2013 May 13.

    PubMed 23670346

  • Jamar G, Pisani LP, Oyama LM, Belote C, Masquio DC, Furuya VA, Carvalho-Ferreira JP, Andrade-Silva SG, Damaso AR, Caranti DA. Is the neck circumference an emergent predictor for inflammatory status in obese adults? Int J Clin Pract. 2013 Mar;67(3):217-24. doi: 10.1111/ijcp.12041.

    PubMed 23409690

  • Carvalho-Ferreira JP, Cipullo MA, Caranti DA, Masquio DC, Andrade-Silva SG, Pisani LP, Damaso AR. Interdisciplinary lifestyle therapy improves binge eating symptoms and body image dissatisfaction in Brazilian obese adults. Trends Psychiatry Psychother. 2012;34(4):223-33. doi: 10.1590/s2237-60892012000400008.

    PubMed 25923071

  • Sanches RB, Andrade-Silva SG, Rossi S, Fidalgo JPN, Moraes AS, Jamar GGQ, Colantonio E, Botero JP, dos Santos RVT, Caranti DA. Body composition and aerobic fitness in obese women: beneficial effects of interdisciplinary therapy. Brazilian Journal of Physical Activity and Health 18(3):354-362, 2013

  • Moraes ADS, Padovani RDC, La Scala Teixeira CV, Cuesta MGS, Gil SDS, de Paula B, Dos Santos GM, Goncalves RT, Damaso AR, Oyama LM, Gomes RJ, Caranti DA. Cognitive Behavioral Approach to Treat Obesity: A Randomized Clinical Trial. Front Nutr. 2021 Feb 18;8:611217. doi: 10.3389/fnut.2021.611217. eCollection 2021.

    PubMed 33681273

Questions about this trial

What is this clinical trial studying?

A study testing Interdisciplinary Therapy in people with Obesity, run by Federal University of São Paulo 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 25 Feb 2020. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Mass (time frame: one year). The study lists 2 primary outcomes in all. 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 NCT02573688, which also lists 6 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 25 Feb 2020.

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