The Effect of CBT- Based Weight Loss Program on Obesity

Study Overview
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Brief Summary
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The investigators purpose is to study how CBT (cognitive behavioral therapy)-based weight loss program affects on eating behavior, weight loss and risk factors for CHD (coronary heart diseases)and type 2 diabetes. Moreover, the investigators aim is to recognize subjects suffering from anhedonia (one of the core symptoms of depression, lack of pleasure) and follow how they benefit from the program in order to achieve maintained weight loss. Also, the associations between weight loss, physical activity and musculoskeletal disorders are studied.

Detailed Description
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Obesity is an increasing problem and effective weight loss methods are needed. The study is randomized follow-up study with 9 months intervention and three (3) years follow-up period. The study is organized in Oulu University Hospital, Department of Internal Medicine. Eighty (80)obese, 20-65 years, study subjects will be randomized into intervention or control group. The hypothesis of the CognObe study is: CBT (cognitive behavioral therapy)-based weight loss program is successful in sustained and favourable change in eating behavior and weight as well as decreased risk for coronary heart diseases or type 2 diabetes.

Official Title
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The Effect of CBT- Based Weight Loss Program on Eating Behavior, Weight Loss Result and Risk for Coronary Heart Diseases and Type 2 Diabetes

Conditions
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Obesity, Hypercholesterolemia, Diabetes Mellitus, Type 2, Anhedonia

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy -based weight loss program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI > 30 Exclusion Criteria: other concurrent weight loss programs disease which prevents weight loss medication which affects on weight loss

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weight loss counseling<br>Cognitive behavioral therapy - based weight loss program | Behavioral: Cognitive behavioral therapy -based weight loss program<br>* CBT-based program includes 20 group visits<br>|
| Other: Control<br>Short term weight loss counseling, control group | Behavioral: Cognitive behavioral therapy -based weight loss program<br>* CBT-based program includes 20 group visits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in weight | kilograms | baseline, 9 months, 1,2 and 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in eating behavior | emotional eating, uncontrolled eating, cognitive restraint, binge eating symptoms | baseline, 9 months, 1,2 and 3 years | 
| change in total cholesterol,HDL, LDL,Trigly and glucose | change in laboratory values | baseline, 1,2 and 3 years | 
| DNA | for genetic analyses | baseline | 
| change in incretins | change in incretins | baseline, 12, 24 and 36 months |