Clinical trial NCT02573688: Interdisciplinary Intervention in Patients With Obesity and Other Metabolic Diseases
Official title: Interdisciplinary Intervention Project - Promotion and Rehabilitation in Patients With Obesity and Other Metabolic Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Metabolic Syndrome X
Interdisciplinary Studies
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Coordination for the Improvement of Higher Education Personnel
First posted: 2015-10-12
Enrollment: 87
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Body Mass
timeFrame: one year
measure: Physical Activity
timeFrame: one year
Secondary outcomes:
measure: Total Cholesterol.
timeFrame: one year
measure: High Density Lipoprotein - Cholesterol
timeFrame: one year
measure: Triglycerides
timeFrame: one year
measure: Glucose levels.
timeFrame: one year
measure: Waist circumference
timeFrame: one year
measure: Blood Pressure
timeFrame: one year
measure: Improvement in Quality of Life
timeFrame: One year
measure: Cardiorespiratory parameters
timeFrame: One year
measure: Resting Metabolic Rate
timeFrame: One year
measure: Psychological Parameters - Anxiety
timeFrame: one year
measure: Psychological Parameters - Depression
timeFrame: one year
measure: Physiotherapy parameters
timeFrame: one year
measure: Nutritional parameters
timeFrame: one year
measure: Inflammatory markers
timeFrame: one year
Other outcomes:
Locations:
city: Santos
country: Brazil
facility: GEO - Obesity Study Group
state: Sao Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Danielle A Caranti, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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.