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

May 4, 2018 updated by: Anna-Maria Keränen, University of Oulu

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Oulu, Finland
        • Deparment of Internal Medicine, Oulu University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI > 30

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Other: Control
Short term weight loss counseling, control group
Behavioral: Cognitive behavioral therapy -based weight loss program
CBT-based program includes 20 group visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in weight
Time Frame: baseline, 9 months, 1,2 and 3 years
kilograms
baseline, 9 months, 1,2 and 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in eating behavior
Time Frame: baseline, 9 months, 1,2 and 3 years
emotional eating, uncontrolled eating, cognitive restraint, binge eating symptoms
baseline, 9 months, 1,2 and 3 years
change in total cholesterol,HDL, LDL,Trigly and glucose
Time Frame: baseline, 1,2 and 3 years
change in laboratory values
baseline, 1,2 and 3 years
DNA
Time Frame: baseline
for genetic analyses
baseline
change in incretins
Time Frame: baseline, 12, 24 and 36 months
change in incretins
baseline, 12, 24 and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oulu

Collaborators

Oulu University Hospital
Juho Vainio Foundation
Yrjo Jahnsson Foundation

Investigators

  • Principal Investigator: Anna-Maria Teeriniemi (nee Keränen), Oulun University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

May 21, 2012

First Submitted That Met QC Criteria

May 23, 2012

First Posted (Estimate)

May 28, 2012

Study Record Updates

Last Update Posted (Actual)

May 11, 2018

Last Update Submitted That Met QC Criteria

May 4, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 58/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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