The Effect of CBT- Based Weight Loss Program on Obesity

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Hypercholesterolemia; Obesity; Anhedonia
• Interventions: Behavioral: Cognitive behavioral therapy -based weight loss program

• Registration Number: NCT01606904
• Lead Sponsor: University of Oulu

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-21
• Study First Submitted QC: 2012-05-23
• Study First Posted: 2012-05-28
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-04
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• BMI > 30

Exclusion Criteria

• other concurrent weight loss programs
• disease which prevents weight loss
• medication which affects on weight loss

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weight loss counseling	Cognitive behavioral therapy -based weight loss program	Cognitive behavioral therapy - based weight loss program
Control	Cognitive behavioral therapy -based weight loss program	Short term weight loss counseling, control group

Primary Outcome Measures

Name	Time	Method
change in weight	baseline, 9 months, 1,2 and 3 years	kilograms

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Deparment of Internal Medicine, Oulu University Hospital; 🇫🇮 Oulu, Finland