The Effect of CBT- Based Weight Loss Program on Obesity

Obesity Clinical Trial

— CognObe  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01606904
• Other study ID #: 58/2012
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: March 2016

Study information

• Verified date: May 2018
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• BMI > 30

Exclusion Criteria:

• other concurrent weight loss programs

• disease which prevents weight loss

• medication which affects on weight loss

Related Conditions & MeSH terms

• Anhedonia
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypercholesterolemia
• Obesity
• Weight Loss

Intervention

Behavioral:
• Cognitive behavioral therapy -based weight loss program
CBT-based program includes 20 group visits

Locations

Country	Name	City	State
Finland	Deparment of Internal Medicine, Oulu University Hospital	Oulu

Sponsors (4)

Lead Sponsor	Collaborator
University of Oulu	Juho Vainio Foundation, Oulu University Hospital, Yrjo Jahnsson Foundation

Country where clinical trial is conducted

Finland, 

References & Publications (3)

Keränen AM, Rasinaho E, Hakko H, Savolainen M, Lindeman S. Eating behavior in obese and overweight persons with and without anhedonia. Appetite. 2010 Dec;55(3):726-9. doi: 10.1016/j.appet.2010.08.012. Epub 2010 Aug 27. — View Citation

Keränen AM, Savolainen MJ, Reponen AH, Kujari ML, Lindeman SM, Bloigu RS, Laitinen JH. The effect of eating behavior on weight loss and maintenance during a lifestyle intervention. Prev Med. 2009 Aug;49(1):32-8. doi: 10.1016/j.ypmed.2009.04.011. Epub 2009 May 4. — View Citation

Keränen AM, Strengell K, Savolainen MJ, Laitinen JH. Effect of weight loss intervention on the association between eating behaviour measured by TFEQ-18 and dietary intake in adults. Appetite. 2011 Feb;56(1):156-62. doi: 10.1016/j.appet.2010.10.004. Epub 2010 Oct 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in weight	kilograms	baseline, 9 months, 1,2 and 3 years
Secondary	change in eating behavior	emotional eating, uncontrolled eating, cognitive restraint, binge eating symptoms	baseline, 9 months, 1,2 and 3 years
Secondary	change in total cholesterol,HDL, LDL,Trigly and glucose	change in laboratory values	baseline, 1,2 and 3 years
Secondary	DNA	for genetic analyses	baseline
Secondary	change in incretins	change in incretins	baseline, 12, 24 and 36 months