A Multidisciplinary Intervention for Weight Loss

Study Overview
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Brief Summary
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This is an open label study in which obese participants were treated with a restrictive hypo-caloric diet under hospitalization for a maximum period of 3 months in a metabolic rehabilitation unit. A multidisciplinary approach was used (combination of diet, physical exercise and psychotherapy)

Official Title
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Efficacy and Safety of a Long-term Multidisciplinary Weight Loss Intervention in Patients With Obesity: an Open Label Study

Conditions
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Obesity

Intervention / Treatment
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* Other: Multidisciplinary treatment of obesity (diet + vitamin D + exercise + psychotherapy)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age >= 18 BMI >= 30 one or more comorbidities (type 2 diabetes mellitus, dyslipidemia, high blood pressure, hyperuricemia, and others) Exclusion Criteria: active cancer severe cognitive or functional impairments severe behavioral disorders known kidney failure (previous glomerular filtration rate <30 ml/min) known liver failure (Child B or C)

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: Open Label study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All participants<br>Obese subjects with BMI >= 30 and with one or more of metabolic comorbidities (type 2 diabetes mellitus, dyslipidemia, high blood pressure, hyperuricemia, and others). | Other: Multidisciplinary treatment of obesity (diet + vitamin D + exercise + psychotherapy)<br>* Body weight reduction was induced by a low-energy mixed diet (55 % carbohydrates, 30 % lipids and 15 % proteins) providing 600 kcal less than individually estimated energy requirements based on the measured REE. The energy content and macronutrient composition of the diets adhered to the nutritional recommendations of the American Diabetes Association. Patients were administered vitamin D supplement only if they presented a value of 25-hydroxyvitamin D (25OHD) <30 ng/ml in blood tests at the beginning. Patients were following an individualized physical activity plan within the hospital and were aided by a psychodynamic approach therapist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight | Change in body Weight | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GlycaemIa | Change in glycaemia | 12 weeks | 
| Insulin | Change in insulin blood levels | 12 weeks | 
| Homa IR | Change in HOMA-IR | 12 weeks | 
| Total cholesterol | Change in blood total cholesterol | 12 weeks | 
| LDL cholesterol | Change in LDL cholesterol | 12 weeks | 
| HDL cholesterol | Change in HDL cholesterol | 12 weeks | 
| Triglycerides | Change in triglycerides | 12 weeks | 
| AST (Aspartate Aminotransferase) | Change in blood of Aspartate Aminotransferase (AST) | 12 weeks | 
| ALT (alanine aminotransferase) | Change in blood of alanine aminotransferase (ALT) | 12 weeks | 
| GGT (gamma-glutamyl transpeptidase) | Change in blood of gamma-glutamyl transpeptidase (GGT) | 12 weeks | 
| Total bilirubin | Change in blood total bilirubin | 12 weeks | 
| Basal metabolic rate | Change in basal metabolic rate | 12 weeks |