Interdisciplinary Intervention in Patients With Obesity and Other Metabolic Diseases

Study Overview
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Interdisciplinary Therapy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interdisciplinary Therapy<br>The Therapy includes: Physical Exercise (three times week - 180 minutes); Nutrition, Psychology, Physiotherapy (once a week - 60 minutes each one) | Behavioral: Interdisciplinary Therapy<br>* 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.<br>* Other names: Lifestyle Improvement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass | Body Mass (kg) | one year | 
| Physical Activity | Quadrimensional accelerometer | one year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Metabolic Syndrome X, Interdisciplinary Studies