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NCT Number: NCT02573688

Interdisciplinary Intervention 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.

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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GEO - Obesity Study Group

Santos, São Paulo, 11045301, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interdisciplinary therapy

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.

Other names: Obesity Treatment, Lifestyle Improvement

Primary outcomes

  1. Body Mass

    Time frame: one year

    Body Mass (kg)

  2. Physical Activity

    Time frame: one year

    Quadrimensional accelerometer

Secondary outcomes

  1. Total Cholesterol.

    Time frame: one year

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

  2. High Density Lipoprotein - Cholesterol

    Time frame: one year

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

  3. Triglycerides

    Time frame: one year

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

  4. Glucose levels.

    Time frame: one year

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

  5. Waist circumference

    Time frame: one year

    Anthropometric measure (cm)

  6. Blood Pressure

    Time frame: one year

    Systolic and Diastolic Blood pressure (mmHg)

  7. Improvement in Quality of Life

    Time frame: One year

    WHO - Quality of life Brief Questionnaire

  8. Cardiorespiratory parameters

    Time frame: One year

    Maximal ergometer test. Maximal oxygen uptake.

  9. Resting Metabolic Rate

    Time frame: One year

    Indirect calorimetry test (kcal/day)

  10. Psychological Parameters - Anxiety

    Time frame: one year

    Anxiety, Beck´s Anxiety Inventory Questionnaire (Score)

  11. Psychological Parameters - Depression

    Time frame: one year

    Depression; Beck´s Depression Inventory Questionnaire (Score)

  12. Physiotherapy parameters

    Time frame: one year

    Functional capacity - Health Assessment Questionnaire (Score)

  13. Nutritional parameters

    Time frame: one year

    Macronutrient, micronutrient and calorie intakes

  14. Inflammatory markers

    Time frame: one year

    adipokines status

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Coordination for the Improvement of Higher Education Personnel
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Oct 12, 2015
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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