Effect of Specific Diet and Physical Activity on Weight and/or Fat Loss

Study Overview
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Brief Summary
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The main purpose of this study is to assess metabolic effects (decreased amount of body fat content, insulin sensitivity and lipid profile improvement) of weight loss intervention based on specific life style counseling (low calorie metabolic stairs diet and circuit-based exercise in a comparison to conventional diet and exercise. The main hypothesis is that more significant beneficial metabolic effects will have specific life style counseling effect than conventional diet and exercise. The main purpose of this study is to assess above mentioned metabolic changes before and after 6-8 weeks of weight loss intervention. The investigators will also study the following: The impact of life style counseling induced weight and/or fat loss on physical fitness The impact of life style counseling induced weight and/or fat loss on metabolic parameters (e.g. insulin sensitivity, lipid profile, ect.)

Detailed Description
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I

Official Title
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Effect of Specific Diet and Circuit-based Exercise on Weight and/or Fat Loss

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Lifestyle Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Volunteers BMI≥25 kg/m2 Exclusion Criteria: Thyroid disease Chronic diseases(rheumatic,liver, kidney, pulmonary, etc. diseases) have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease, or diabetes; chronic infections show evidence of malignancy be women who are pregnant, nursing medical treatment except allergy medicines tobacco, alcohol or drug addiction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional lifestyle counseling<br>Randomized, open label study to assess effect of 8 weeks of Conventional lifestyle counseling (low calorie diet and exercise) on body composition, physical fitness, and metabolic parameters | Behavioral: Lifestyle Counseling<br>* In both arms life style counseling: Low calorie diet- 30% reduction of weight maintenance calories (TDEE); and recommended moderate exercise 3 times per week 45 minutes.<br>|
| Active Comparator: Unconventional lifestyle counseling<br>Randomized, open label study to assess effect of 8 weeks of unconventional lifestyle counseling (low calorie metabolic stairs diet and circuit-based exercise) on body composition, physical fitness, and metabolic parameters | Behavioral: Lifestyle Counseling<br>* In both arms life style counseling: Low calorie diet- 30% reduction of weight maintenance calories (TDEE); and recommended moderate exercise 3 times per week 45 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A Body weight change after specific weight loss intervention | To assess the body composition changes (fat-free mass and fat mass (in kg)). | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic parameters | Insulin sensitivity Total, HDL, LDL, small dense-LDL cholesterol levels | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overweight and obesity, adipose tissue, weight loss program, low-calorie diet, circuit-based exercise, metabolic cardiovascular syndrome