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.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Glycated hemoglobin (HbA1c)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •Diagnosed depression ( F32.0, F32.1, F32.2, F33.0, F33.1, F33.2)
- •BMI > 35
排除标准
- •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
研究组 & 干预措施
CBT-Based Weight Loss Model
CBT- Based weight loss model
干预措施: CBT-based weight loss model (Behavioral)
Control
Usual Care
干预措施: Control (Behavioral)
结局指标
主要结局
Change in Glycated hemoglobin (HbA1c)
时间窗: baseline and change from baseline to 1 year and 2 years
Measured by laboratory analyses
Change in Weight
时间窗: baseline and change from baseline to 1 year and 2 years
Measured by scale on baseline, 1 year and 2 years
Change in Lipids
时间窗: 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
时间窗: baseline and change from baseline to 1 year and 2 years
Measured by laboratory analyses
Change in Waist circumference
时间窗: baseline and change from baseline to 1 year and 2 years
Measured by tape measure on baseline, 1 year and 2 years
Change in c-reactive protein level
时间窗: baseline and change from baseline to 1 year and 2 years
Measured by laboratory analyses
次要结局
- Change in Mood(baseline and change from baseline to 1 year and 2 years)
- Change in Anxiety(baseline and change from baseline to 1 year and 2 years)
- Change in Quality of life(baseline and change from baseline to 1 year and 2 years)
- Change in Sense of coherence(baseline and change from baseline to 1 year and 2 years)
- Change in Eating behavior assessed by TFEQ-18 questionnaire(baseline and change from baseline to 1 year and 2 years)
- Change in Eating behavior assessed by BES-questionnaire(baseline and change from baseline to 1 year and 2 years)
- Change in Intuitive Eating behavior(baseline and change from baseline to 1 year and 2 years)
- Change in Use of alcohol and tobacco(baseline and change from baseline to 1 year and 2 years)
- Change in Self-efficacy: questionnaire(baseline and change from baseline to 1 year and 2 years)
- Change in Physical acitivity(baseline and change from baseline to 1 year and 2 years)
- Change in Sleep(baseline and change from baseline to 1 year and 2 years)
- Previous weight loss(baseline)