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Interdisciplinary Intervention in Patients With Obesity and Other Metabolic Diseases

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Interdisciplinary Therapy
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Metabolic Syndrome X, Interdisciplinary Studies

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GEO - Obesity Study Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interdisciplinary Therapy

Arm Description

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

Outcomes

Primary Outcome Measures

Body Mass
Body Mass (kg)
Physical Activity
Quadrimensional accelerometer

Secondary Outcome Measures

Total Cholesterol.
Blood lipid fraction (mg/dL) after 12h overnight fasting.
High Density Lipoprotein - Cholesterol
HDL-c; Blood lipid fraction (mg/dL) after 12h overnight fasting.
Triglycerides
Blood lipid fraction (mg/dL) after 12h overnight fasting.
Glucose levels.
Glucose levels (mg/dL) after 12h overnight fasting.
Waist circumference
Anthropometric measure (cm)
Blood Pressure
Systolic and Diastolic Blood pressure (mmHg)
Improvement in Quality of Life
WHO - Quality of life Brief Questionnaire
Cardiorespiratory parameters
Maximal ergometer test. Maximal oxygen uptake.
Resting Metabolic Rate
Indirect calorimetry test (kcal/day)
Psychological Parameters - Anxiety
Anxiety, Beck´s Anxiety Inventory Questionnaire (Score)
Psychological Parameters - Depression
Depression; Beck´s Depression Inventory Questionnaire (Score)
Physiotherapy parameters
Functional capacity - Health Assessment Questionnaire (Score)
Nutritional parameters
Macronutrient, micronutrient and calorie intakes
Inflammatory markers
adipokines status

Full Information

First Posted
October 2, 2015
Last Updated
February 22, 2020
Sponsor
Federal University of São Paulo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordination for the Improvement of Higher Education Personnel
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1. Study Identification

Unique Protocol Identification Number
NCT02573688
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordination for the Improvement of Higher Education Personnel

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Metabolic Syndrome X, Interdisciplinary Studies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interdisciplinary Therapy
Arm Type
Experimental
Arm Description
The Therapy includes: Physical Exercise (three times week - 180 minutes); Nutrition, Psychology, Physiotherapy (once a week - 60 minutes each one)
Intervention Type
Behavioral
Intervention Name(s)
Interdisciplinary Therapy
Other Intervention Name(s)
Obesity Treatment, Lifestyle Improvement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body Mass
Description
Body Mass (kg)
Time Frame
one year
Title
Physical Activity
Description
Quadrimensional accelerometer
Time Frame
one year
Secondary Outcome Measure Information:
Title
Total Cholesterol.
Description
Blood lipid fraction (mg/dL) after 12h overnight fasting.
Time Frame
one year
Title
High Density Lipoprotein - Cholesterol
Description
HDL-c; Blood lipid fraction (mg/dL) after 12h overnight fasting.
Time Frame
one year
Title
Triglycerides
Description
Blood lipid fraction (mg/dL) after 12h overnight fasting.
Time Frame
one year
Title
Glucose levels.
Description
Glucose levels (mg/dL) after 12h overnight fasting.
Time Frame
one year
Title
Waist circumference
Description
Anthropometric measure (cm)
Time Frame
one year
Title
Blood Pressure
Description
Systolic and Diastolic Blood pressure (mmHg)
Time Frame
one year
Title
Improvement in Quality of Life
Description
WHO - Quality of life Brief Questionnaire
Time Frame
One year
Title
Cardiorespiratory parameters
Description
Maximal ergometer test. Maximal oxygen uptake.
Time Frame
One year
Title
Resting Metabolic Rate
Description
Indirect calorimetry test (kcal/day)
Time Frame
One year
Title
Psychological Parameters - Anxiety
Description
Anxiety, Beck´s Anxiety Inventory Questionnaire (Score)
Time Frame
one year
Title
Psychological Parameters - Depression
Description
Depression; Beck´s Depression Inventory Questionnaire (Score)
Time Frame
one year
Title
Physiotherapy parameters
Description
Functional capacity - Health Assessment Questionnaire (Score)
Time Frame
one year
Title
Nutritional parameters
Description
Macronutrient, micronutrient and calorie intakes
Time Frame
one year
Title
Inflammatory markers
Description
adipokines status
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle A Caranti, PhD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Study Director
Facility Information:
Facility Name
GEO - Obesity Study Group
City
Santos
State/Province
Sao Paulo
ZIP/Postal Code
11045301
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
26372897
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.
Results Reference
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PubMed Identifier
23670346
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.
Results Reference
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PubMed Identifier
23409690
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.
Results Reference
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PubMed Identifier
25923071
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.
Results Reference
background
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
Results Reference
background
PubMed Identifier
33681273
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.
Results Reference
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Interdisciplinary Intervention in Patients With Obesity and Other Metabolic Diseases

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