The aim of this study is find out how CBT-based weight loss program affects on eating behavior, weight loss, mood symptoms and risk for coronary heart diseases and type 2 diabetes and applicability of the program to obesity treatment among patients with comorbid depression. Our hypothesis is that the CBT-based intervention improves long-term weight management results and supports positively the change in eating behavior and the risk for CHD on type 2 DM. The study is randomized controlled one-year intervention study with 1 year follow-up. Study subjects are adult obese (BMI\>35) subjects with comorbid depression. Number of randomized study subjects will be 80, 40 in intervention group, 40 in control group. Intervention group will proceed through a 52-week CBT-based weight loss group intervention. The aim of the intervention is to modify eating behavior and lifestyle factors affecting weight and weight maintenance. There will be 22 group counselling of 90 minutes divided in five modules and also three individual person-centered counselling visit, during which participants had an opportunity to discuss their personal concerns about diet and weight loss plan. Control group will receive the usual care of obesity in Kuopio University hospital. (4-8 individual 45-minute visit conducted by dieticians) Study visits are at baseline and one and 2 years after baseline. For example eating behavior, health behavior, motivation and depression are studied with questionnaires. Weight, waist circumference, height and blood pressure are measured. Laboratory tests (lipid, glucose etc) are taken.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Methods of cognitive behavioral psychotherapy
Treatment as usual
Kuopio University Hospital
Kuopio, Finland
RECRUITINGChange in Weight
Measured by scale on baseline, 1 year and 2 years
Time frame: baseline and change from baseline to 1 year and 2 years
Change in Lipids
Measured by laboratory analyses (total cholesterol,High-density lipoprotein, Low-density lipoprotein, Triglyserides
Time frame: baseline and change from baseline to 1 year and 2 years
Change in Blood glucose
Measured by laboratory analyses
Time frame: baseline and change from baseline to 1 year and 2 years
Change in c-reactive protein level
Measured by laboratory analyses
Time frame: baseline and change from baseline to 1 year and 2 years
Change in Glycated hemoglobin (HbA1c)
Measured by laboratory analyses
Time frame: baseline and change from baseline to 1 year and 2 years
Change in Waist circumference
Measured by tape measure on baseline, 1 year and 2 years
Time frame: baseline and change from baseline to 1 year and 2 years
Change in Eating behavior assessed by TFEQ-18 questionnaire
Three Factor Eating questionnaire-18 measures three eating behavior traits: emotional eating, cognitive restraint and uncontrolled eating.
Time frame: baseline and change from baseline to 1 year and 2 years
Change in Eating behavior assessed by BES-questionnaire
BES -questionnaire assess binge eating symptoms.
Time frame: baseline and change from baseline to 1 year and 2 years
Change in Intuitive Eating behavior
assessed by IES2 (Intuitive Eating Scale) questionnaire,
Time frame: baseline and change from baseline to 1 year and 2 years
Change in Physical acitivity
assessed by questionnaire assessing physical activity
Time frame: baseline and change from baseline to 1 year and 2 years
Change in Sleep
assessed by questionnaire
Time frame: baseline and change from baseline to 1 year and 2 years
Change in Use of alcohol and tobacco
assessed by questionnaire
Time frame: baseline and change from baseline to 1 year and 2 years
Previous weight loss
assessed by questioinnaire
Time frame: baseline
Change in Mood
assessed by BDI (Beck Depression Inventory) questionnaire
Time frame: baseline and change from baseline to 1 year and 2 years
Change in Anxiety
assessed by BAI (Beck Anxiety Inventory) questionnaire
Time frame: baseline and change from baseline to 1 year and 2 years
Change in Quality of life
Assesed by 15D questionnaire
Time frame: baseline and change from baseline to 1 year and 2 years
Change in Self-efficacy: questionnaire
assessed by WEL questionnaire
Time frame: baseline and change from baseline to 1 year and 2 years
Change in Sense of coherence
assesed by SOC13 (Sense of Coherence) questionnaire
Time frame: baseline and change from baseline to 1 year and 2 years
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