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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 (CognObe)

This study is currently recruiting participants.
Verified May 2012 by University of Oulu
Sponsor:
Collaborators:
Juho Vainio Foundation
Yrjö Jahnsson Foundation, Finland
prof Markku Savolainen´s study group, University of Oulu, Faculty of medicine, institue of clinical medicine, Department of Internal Medicine
Information provided by (Responsible Party):
Anna-Maria Keränen, University of Oulu
ClinicalTrials.gov Identifier:
NCT01606904
First received: May 21, 2012
Last updated: May 23, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention
Obesity
Hypercholesterolemia
Diabetes Mellitus, Type 2
Anhedonia
 Behavioral: Cognitive behavioral therapy -based weight loss program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • change in weight [ Time Frame: baseline, 9 months, 1,2 and 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in eating behavior [ Time Frame: baseline, 9 months, 1,2 and 3 years ] [ Designated as safety issue: No ]
    emotional eating, uncontrolled eating, cognitive restraint, binge eating symptoms

  • change in total cholesterol,HDL, LDL,Trigly and glucose [ Time Frame: baseline, 1,2 and 3 years ] [ Designated as safety issue: No ]
  • DNA [ Time Frame: baseline ] [ Designated as safety issue: No ]
    for genetic analyses

  • change in incretins [ Time Frame: baseline, 12, 24 and 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: May 2012
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Weight loss counseling
Cognitive behavioral therapy - based weight loss program
 Behavioral: Cognitive behavioral therapy -based weight loss program
CBT-based program includes 20 group visits
Experimental: Control
short term weight loss counseling, control group
 Behavioral: Cognitive behavioral therapy -based weight loss program
CBT-based program includes 20 group visits

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

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI > 30

Exclusion Criteria:

  • other concurrent weight loss programs
  • disease which prevents weight loss
  • medication which affects on weight loss
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01606904

Locations
Finland
Deparment of Internal Medicine, Oulu University Hospital Recruiting
Oulu, Finland
Contact: Anna-Maria Keränen, PhD     +358-8-3155621        
Contact: Terhi Jokelainen, MSc            
Sub-Investigator: Anna-Maria Keränen, PhD            
Principal Investigator: Markku Savolainen, professor            
Sub-Investigator: Terhi Jokelainen, MSc            
Sub-Investigator: Mona-Lisa Kujari, MD            
Sub-Investigator: Sari Lindeman, prof            
Sponsors and Collaborators
University of Oulu
Juho Vainio Foundation
Yrjö Jahnsson Foundation, Finland
prof Markku Savolainen´s study group, University of Oulu, Faculty of medicine, institue of clinical medicine, Department of Internal Medicine
  More Information

Publications:

Responsible Party: Anna-Maria Keränen, P.h.D, clinical nutritionist, University of Oulu
ClinicalTrials.gov Identifier: NCT01606904     History of Changes
Other Study ID Numbers: 58/2012
Study First Received: May 21, 2012
Last Updated: May 23, 2012
Health Authority: Finland: Regional ethics committee of the Northern Ostrobothnia Ethics Committee,Northern Ostrobothnia Hospital District

Additional relevant MeSH terms:
Coronary Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypercholesterolemia
Obesity
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013