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The Effect of CBT- Based Weight Loss Program on Obesity (CognObe)

Primary Purpose

Obesity, Hypercholesterolemia, Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Cognitive behavioral therapy -based weight loss program
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI > 30

Exclusion Criteria:

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

Sites / Locations

  • Deparment of Internal Medicine, Oulu University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Weight loss counseling

Control

Arm Description

Cognitive behavioral therapy - based weight loss program

Short term weight loss counseling, control group

Outcomes

Primary Outcome Measures

change in weight
kilograms

Secondary Outcome Measures

change in eating behavior
emotional eating, uncontrolled eating, cognitive restraint, binge eating symptoms
change in total cholesterol,HDL, LDL,Trigly and glucose
change in laboratory values
DNA
for genetic analyses
change in incretins
change in incretins

Full Information

First Posted
May 21, 2012
Last Updated
May 4, 2018
Sponsor
University of Oulu
Collaborators
Juho Vainio Foundation, Yrjo Jahnsson Foundation, Oulu University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01606904
Brief Title
The Effect of CBT- Based Weight Loss Program on Obesity
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu
Collaborators
Juho Vainio Foundation, Yrjo Jahnsson Foundation, Oulu University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Hypercholesterolemia, Diabetes Mellitus, Type 2, Anhedonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Weight loss counseling
Arm Type
Experimental
Arm Description
Cognitive behavioral therapy - based weight loss program
Arm Title
Control
Arm Type
Other
Arm Description
Short term weight loss counseling, control group
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy -based weight loss program
Intervention Description
CBT-based program includes 20 group visits
Primary Outcome Measure Information:
Title
change in weight
Description
kilograms
Time Frame
baseline, 9 months, 1,2 and 3 years
Secondary Outcome Measure Information:
Title
change in eating behavior
Description
emotional eating, uncontrolled eating, cognitive restraint, binge eating symptoms
Time Frame
baseline, 9 months, 1,2 and 3 years
Title
change in total cholesterol,HDL, LDL,Trigly and glucose
Description
change in laboratory values
Time Frame
baseline, 1,2 and 3 years
Title
DNA
Description
for genetic analyses
Time Frame
baseline
Title
change in incretins
Description
change in incretins
Time Frame
baseline, 12, 24 and 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI > 30 Exclusion Criteria: other concurrent weight loss programs disease which prevents weight loss medication which affects on weight loss
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna-Maria Teeriniemi (nee Keränen)
Organizational Affiliation
Oulun University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deparment of Internal Medicine, Oulu University Hospital
City
Oulu
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
19406146
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.
Results Reference
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PubMed Identifier
20955744
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.
Results Reference
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PubMed Identifier
20801180
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.
Results Reference
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The Effect of CBT- Based Weight Loss Program on Obesity

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