The Effect and Applicability of CBT-Based Weight Loss Treatment Model in Obese Patients With Comorbid Depression in Health Care

NCT04513587 | Recruiting

• 1 other identifier: 510RA21
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Depression; Cognitive Behavioral Therapy; Weight Loss

Outcome Measures

Primary Outcomes (6)

• Change in Weight

  Measured by scale on baseline, 1 year and 2 years

  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

  baseline and change from baseline to 1 year and 2 years

• Change in Blood glucose

  Measured by laboratory analyses

  baseline and change from baseline to 1 year and 2 years

• Change in c-reactive protein level

  Measured by laboratory analyses

  baseline and change from baseline to 1 year and 2 years

• Change in Glycated hemoglobin (HbA1c)

  Measured by laboratory analyses

  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

  baseline and change from baseline to 1 year and 2 years

Secondary Outcomes (12)

• 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 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

Study Arms (2)

CBT-Based Weight Loss Model

EXPERIMENTAL

CBT- Based weight loss model

Behavioral: CBT-based weight loss model

Control

ACTIVE COMPARATOR

Usual Care

Behavioral: Control

Interventions

CBT-based weight loss model BEHAVIORAL

Methods of cognitive behavioral psychotherapy

CBT-Based Weight Loss Model

Control BEHAVIORAL

Treatment as usual

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kuopio University Hospital: lead
• University of Oulu: collaborator
• Jyväskylä Central Hospital: collaborator
• Oulu University Hospital: collaborator
• University of Eastern Finland: collaborator

Study Sites (1)

Kuopio University Hospital

Kuopio, Finland

RECRUITING

MeSH Terms

Conditions

Obesity; Depression; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Body Weight Changes

Study Officials

• Anna-Maria Teeriniemi, PhD

  Kuopio University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna-Maria Teeriniemi, PhD

CONTACT

+358447113148; anna-maria.teeriniemi@kuh.fi

Sanna Rajapolvi, MSc

CONTACT

+358447176209; sanna.rajapolvi@kuh.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized intervention study

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: August 14, 2020
• Study Start: September 1, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)