Interdisciplinary Intervention in Patients With Obesity and Other Metabolic Diseases

NCT ID: NCT02573688

Last Updated: 2020-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-08-31

Brief Summary

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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.

Detailed Description

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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

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Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interdisciplinary Therapy

The Therapy includes: Physical Exercise (three times week - 180 minutes); Nutrition, Psychology, Physiotherapy (once a week - 60 minutes each one)

Group Type EXPERIMENTAL

Interdisciplinary Therapy

Intervention Type BEHAVIORAL

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.

Interventions

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Interdisciplinary Therapy

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Obesity Treatment Lifestyle Improvement

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Coordination for the Improvement of Higher Education Personnel

OTHER

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Danielle Arisa Caranti

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Danielle A Caranti, PhD

Role: STUDY_DIRECTOR

Federal University of São Paulo

Locations

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GEO - Obesity Study Group

Santos, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 26372897 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23670346 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23409690 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25923071 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type DERIVED
PMID: 33681273 (View on PubMed)

Other Identifiers

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LIDM-2014-GEO

Identifier Type: -

Identifier Source: org_study_id

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