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Completed

NCT Number: NCT01606904

The Effect of CBT- Based Weight Loss Program on Obesity

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.

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Key information

Conditions

Obesity Anhedonia Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Deparment of Internal Medicine, Oulu University Hospital

Oulu, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI > 30

Exclusion criteria

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

Treatment and study plan

Cognitive behavioral therapy -based weight loss program

Behavioral

CBT-based program includes 20 group visits

Primary outcomes

  1. change in weight

    Time frame: baseline, 9 months, 1,2 and 3 years

    kilograms

Secondary outcomes

  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

    change in laboratory values

  3. DNA

    Time frame: baseline

    for genetic analyses

  4. change in incretins

    Time frame: baseline, 12, 24 and 36 months

    change in incretins

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Collaborators

  • Juho Vainio Foundation
  • Oulu University Hospital
  • Yrjo Jahnsson Foundation

Registry information

Official study 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

Acronym: CognObe

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
May 28, 2012
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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