Clinical trial NCT04513587: The Effect and Applicability of CBT-Based Weight Loss Treatment Model in Obese Patients With Comorbid Depression in Health Care
Official title: CBT-Based Weight Loss Treatment Model in Obese Patients With Comorbid Depression. Effect on Eating Behavior, Weight Loss, Mood, and Risk of Coronary Artery Disease and Diabetes.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Depression
Cognitive Behavioral Therapy
Weight Loss
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oulu
name: Jyväskylä Central Hospital
name: Oulu University Hospital
name: University of Eastern Finland
First posted: 2020-08-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized intervention study
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* Diagnosed depression ( F32.0, F32.1, F32.2, F33.0, F33.1, F33.2)
* BMI \> 35

Exclusion Criteria:

* 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)
* Simultaneous participation in another weight loss program
* Severe vision, hearing, motoric deficiency

Primary outcomes:
measure: Change in Weight
timeFrame: baseline and change from baseline to 1 year and 2 years
measure: Change in Lipids
timeFrame: baseline and change from baseline to 1 year and 2 years
measure: Change in Blood glucose
timeFrame: baseline and change from baseline to 1 year and 2 years
measure: Change in c-reactive protein level
timeFrame: baseline and change from baseline to 1 year and 2 years
measure: Change in Glycated hemoglobin (HbA1c)
timeFrame: baseline and change from baseline to 1 year and 2 years
measure: Change in Waist circumference
timeFrame: baseline and change from baseline to 1 year and 2 years
Secondary outcomes:
measure: Change in Eating behavior assessed by TFEQ-18 questionnaire
timeFrame: baseline and change from baseline to 1 year and 2 years
measure: Change in Eating behavior assessed by BES-questionnaire
timeFrame: baseline and change from baseline to 1 year and 2 years
measure: Change in Intuitive Eating behavior
timeFrame: baseline and change from baseline to 1 year and 2 years
measure: Change in Physical acitivity
timeFrame: baseline and change from baseline to 1 year and 2 years
measure: Change in Sleep
timeFrame: baseline and change from baseline to 1 year and 2 years
measure: Change in Use of alcohol and tobacco
timeFrame: baseline and change from baseline to 1 year and 2 years
measure: Previous weight loss
timeFrame: baseline
measure: Change in Mood
timeFrame: baseline and change from baseline to 1 year and 2 years
measure: Change in Anxiety
timeFrame: baseline and change from baseline to 1 year and 2 years
measure: Change in Quality of life
timeFrame: baseline and change from baseline to 1 year and 2 years
measure: Change in Self-efficacy: questionnaire
timeFrame: baseline and change from baseline to 1 year and 2 years
measure: Change in Sense of coherence
timeFrame: baseline and change from baseline to 1 year and 2 years
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
Study officials:
affiliation: Kuopio University Hospital
name: Anna-Maria Teeriniemi, PhD
role: PRINCIPAL_INVESTIGATOR
References: