PsyCognObe2: The Effect and Applicability of CBT-Based Weight Loss Treatment Model in Obese Patients With Comorbid Depression in Health Care
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CBT-Based Weight Loss Model CBT- Based weight loss model |
Behavioral: CBT-based weight loss model
Methods of cognitive behavioral psychotherapy
|
| Active Comparator: Control Usual Care |
Behavioral: Control
Treatment as usual
|
Outcome Measures
Primary Outcome Measures
- Change in Weight [baseline and change from baseline to 1 year and 2 years]
Measured by scale on baseline, 1 year and 2 years
- Change in Lipids [baseline and change from baseline to 1 year and 2 years]
Measured by laboratory analyses (total cholesterol,High-density lipoprotein, Low-density lipoprotein, Triglyserides
- Change in Blood glucose [baseline and change from baseline to 1 year and 2 years]
Measured by laboratory analyses
- Change in c-reactive protein level [baseline and change from baseline to 1 year and 2 years]
Measured by laboratory analyses
- Change in Glycated hemoglobin (HbA1c) [baseline and change from baseline to 1 year and 2 years]
Measured by laboratory analyses
- Change in Waist circumference [baseline and change from baseline to 1 year and 2 years]
Measured by tape measure on baseline, 1 year and 2 years
Secondary Outcome Measures
- Change in Eating behavior assessed by TFEQ-18 questionnaire [baseline and change from baseline to 1 year and 2 years]
Three Factor Eating questionnaire-18 measures three eating behavior traits: emotional eating, cognitive restraint and uncontrolled eating.
- Change in Eating behavior assessed by BES-questionnaire [baseline and change from baseline to 1 year and 2 years]
BES -questionnaire assess binge eating symptoms.
- Change in Intuitive Eating behavior [baseline and change from baseline to 1 year and 2 years]
assessed by IES2 (Intuitive Eating Scale) questionnaire,
- Change in Physical acitivity [baseline and change from baseline to 1 year and 2 years]
assessed by questionnaire assessing physical activity
- Change in Sleep [baseline and change from baseline to 1 year and 2 years]
assessed by questionnaire
- Change in Use of alcohol and tobacco [baseline and change from baseline to 1 year and 2 years]
assessed by questionnaire
- Previous weight loss [baseline]
assessed by questioinnaire
- Change in Mood [baseline and change from baseline to 1 year and 2 years]
assessed by BDI (Beck Depression Inventory) questionnaire
- Change in Anxiety [baseline and change from baseline to 1 year and 2 years]
assessed by BAI (Beck Anxiety Inventory) questionnaire
- Change in Quality of life [baseline and change from baseline to 1 year and 2 years]
Assesed by 15D questionnaire
- Change in Self-efficacy: questionnaire [baseline and change from baseline to 1 year and 2 years]
assessed by WEL questionnaire
- Change in Sense of coherence [baseline and change from baseline to 1 year and 2 years]
assesed by SOC13 (Sense of Coherence) questionnaire
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18-65 years
-
Diagnosed depression ( F32.0, F32.1, F32.2, F33.0, F33.1, F33.2)
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BMI > 35
Exclusion Criteria:
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Psychotic disorder, schizoaffective disorder, psychotic depression or bipolar disorder
-
Severe current substance abuse
-
Serious psychiatric condition (i.e self-destructive or impulsive behavior)
-
Clinically significant illness contraindicating weight loss (i.e cancer or severe heart disease)
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Simultaneous participation in another weight loss program
-
Severe vision, hearing, motoric deficiency
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kuopio University Hospital | Kuopio | Finland |
Sponsors and Collaborators
- Kuopio University Hospital
- University of Oulu
- Jyväskylä Central Hospital
- Oulu University Hospital
- University of Eastern Finland
Investigators
- Principal Investigator: Anna-Maria Teeriniemi, PhD, Kuopio University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 510RA21