Interdisciplinary Intervention in Patients With Obesity and Other Metabolic Diseases

February 22, 2020 updated by: Danielle Arisa Caranti, Federal University of São Paulo

Interdisciplinary Intervention Project - Promotion and Rehabilitation 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • Santos, Sao Paulo, Brazil, 11045301
        • GEO - Obesity Study Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Collaborators

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

Investigators

  • Study Director: Danielle A Caranti, PhD, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

October 2, 2015

First Submitted That Met QC Criteria

October 8, 2015

First Posted (Estimate)

October 12, 2015

Study Record Updates

Last Update Posted (Actual)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 22, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIDM-2014-GEO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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