Clinical trial NCT01606904: The Effect of CBT- Based Weight Loss Program on Obesity
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Hypercholesterolemia
Diabetes Mellitus, Type 2
Anhedonia
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Juho Vainio Foundation
name: Yrjo Jahnsson Foundation
name: Oulu University Hospital
First posted: 2012-05-28
Enrollment: 62
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* BMI \> 30

Exclusion Criteria:

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

Primary outcomes:
measure: change in weight
timeFrame: baseline, 9 months, 1,2 and 3 years
Secondary outcomes:
measure: change in eating behavior
timeFrame: baseline, 9 months, 1,2 and 3 years
measure: change in total cholesterol,HDL, LDL,Trigly and glucose
timeFrame: baseline, 1,2 and 3 years
measure: DNA
timeFrame: baseline
measure: change in incretins
timeFrame: baseline, 12, 24 and 36 months
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Deparment of Internal Medicine, Oulu University Hospital
Study officials:
affiliation: Oulun University Hospital
name: Anna-Maria Teeriniemi (nee Keränen)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Keranen 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.
citation: Keranen 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.
citation: Keranen 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.