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Interdisciplinary Intervention in Patients With Obesity and Other Metabolic Diseases

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02573688
Enrollment
87
Registered
2015-10-12
Start date
2017-01-31
Completion date
2018-08-31
Last updated
2020-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Obesity, Metabolic Syndrome X, Interdisciplinary Studies

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.

Interventions

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.

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico
CollaboratorOTHER_GOV
Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
Coordination for the Improvement of Higher Education Personnel
CollaboratorOTHER
Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Body Massone yearBody Mass (kg)
Physical Activityone yearQuadrimensional accelerometer

Secondary

MeasureTime frameDescription
Triglyceridesone yearBlood lipid fraction (mg/dL) after 12h overnight fasting.
Glucose levels.one yearGlucose levels (mg/dL) after 12h overnight fasting.
Waist circumferenceone yearAnthropometric measure (cm)
Blood Pressureone yearSystolic and Diastolic Blood pressure (mmHg)
Improvement in Quality of LifeOne yearWHO - Quality of life Brief Questionnaire
Cardiorespiratory parametersOne yearMaximal ergometer test. Maximal oxygen uptake.
Total Cholesterol.one yearBlood lipid fraction (mg/dL) after 12h overnight fasting.
Psychological Parameters - Anxietyone yearAnxiety, Beck´s Anxiety Inventory Questionnaire (Score)
Psychological Parameters - Depressionone yearDepression; Beck´s Depression Inventory Questionnaire (Score)
Physiotherapy parametersone yearFunctional capacity - Health Assessment Questionnaire (Score)
Nutritional parametersone yearMacronutrient, micronutrient and calorie intakes
Inflammatory markersone yearadipokines status
Resting Metabolic RateOne yearIndirect calorimetry test (kcal/day)
High Density Lipoprotein - Cholesterolone yearHDL-c; Blood lipid fraction (mg/dL) after 12h overnight fasting.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026