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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)

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ClinicalTrials.gov Identifier: NCT01606904
Recruitment Status : Unknown
Verified May 2012 by Anna-Maria Keränen, University of Oulu.
Recruitment status was:  Recruiting
First Posted : May 28, 2012
Last Update Posted : May 28, 2012
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

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

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2012
Estimated Primary Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. change in weight [ Time Frame: baseline, 9 months, 1,2 and 3 years ]

Secondary Outcome Measures :
  1. change in eating behavior [ Time Frame: baseline, 9 months, 1,2 and 3 years ]
    emotional eating, uncontrolled eating, cognitive restraint, binge eating symptoms

  2. change in total cholesterol,HDL, LDL,Trigly and glucose [ Time Frame: baseline, 1,2 and 3 years ]
  3. DNA [ Time Frame: baseline ]
    for genetic analyses

  4. change in incretins [ Time Frame: baseline, 12, 24 and 36 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Yrjo Jahnsson Foundation
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
First Posted: May 28, 2012    Key Record Dates
Last Update Posted: May 28, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypercholesterolemia
Anhedonia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms