ObesityPsyCognObe2NCT04513587
The Effect and Applicability of CBT-Based Weight Loss Treatment Model in Obese Patients With Comorbid Depression in Health Care
A study testing CBT-based weight loss model in people with Obesity and Depression, run by Kuopio University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Depression, Cognitive Behavioral Therapy
- What is being tested?
- CBT-based weight loss model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFinland
- Study dates
- 1 Sep 2019to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- Diagnosed depression ( F32.0, F32.1, F32.2, F33.0, F33.1, F33.2)
- BMI > 35
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Kuopio University Hospital
Kuopio
Anna-Maria Teeriniemi, +358447113148, anna-maria.teeriniemi@kuh.fi
About this study
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.
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.
Read more
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
- Being tested
- CBT-based weight loss model, Control
- Medical subject headings
- Obesity, Depression, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-based weight loss modelBehavioural
Methods of cognitive behavioral psychotherapy
ControlBehavioural
Treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| CBT-Based Weight Loss Model | Experimental | CBT- Based weight loss model Receives: Behavioral: CBT-based weight loss model |
| Control | Active comparator | Usual Care Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
Measured by scale on baseline, 1 year and 2 years
Measured: 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
Measured: baseline and change from baseline to 1 year and 2 years
Change in Blood glucose
Measured by laboratory analyses
Measured: baseline and change from baseline to 1 year and 2 years
Change in c-reactive protein level
Measured by laboratory analyses
Measured: baseline and change from baseline to 1 year and 2 years
Change in Glycated hemoglobin (HbA1c)
Measured by laboratory analyses
Measured: 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
Measured: baseline and change from baseline to 1 year and 2 years
Secondary outcomes (12)
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.
Measured: 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.
Measured: baseline and change from baseline to 1 year and 2 years
Change in Intuitive Eating behavior
assessed by IES2 (Intuitive Eating Scale) questionnaire,
Measured: baseline and change from baseline to 1 year and 2 years
Change in Physical acitivity
assessed by questionnaire assessing physical activity
Measured: baseline and change from baseline to 1 year and 2 years
Change in Sleep
assessed by questionnaire
Measured: baseline and change from baseline to 1 year and 2 years
Change in Use of alcohol and tobacco
assessed by questionnaire
Measured: baseline and change from baseline to 1 year and 2 years
Previous weight loss
assessed by questioinnaire
Measured: baseline
Change in Mood
assessed by BDI (Beck Depression Inventory) questionnaire
Measured: baseline and change from baseline to 1 year and 2 years
Change in Anxiety
assessed by BAI (Beck Anxiety Inventory) questionnaire
Measured: baseline and change from baseline to 1 year and 2 years
Change in Quality of life
Assesed by 15D questionnaire
Measured: baseline and change from baseline to 1 year and 2 years
Change in Self-efficacy: questionnaire
assessed by WEL questionnaire
Measured: baseline and change from baseline to 1 year and 2 years
Change in Sense of coherence
assesed by SOC13 (Sense of Coherence) questionnaire
Measured: baseline and change from baseline to 1 year and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start1 Sep 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized intervention study
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oulu, Jyväskylä Central Hospital, Oulu University Hospital, University of Eastern Finland
- Responsible party
- Sponsor
- Investigators
- Anna-Maria Teeriniemi, PhD, Principal investigator, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513587
- Sponsor's protocol ID
- 510RA21
- Acronym
- PsyCognObe2
- Status last verified
- Mar 2024
- First submitted
- 28 Aug 2019
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04513587
- Acronym / sponsor ID
- PsyCognObe2 / 510RA21
- Conditions
- Obesity, Depression, Cognitive Behavioral Therapy, Weight Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- University of Oulu, Jyväskylä Central Hospital, Oulu University Hospital, University of Eastern Finland
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized intervention study
| Arm | Type | Receives |
|---|---|---|
| CBT-Based Weight Loss Model | Experimental | Behavioral: CBT-based weight loss modelCBT- Based weight loss model |
| Control | Active comparator | Behavioral: ControlUsual Care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years
- Diagnosed depression ( F32.0, F32.1, F32.2, F33.0, F33.1, F33.2)
- BMI > 35
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT-based weight loss modelMethods of cognitive behavioral psychotherapy | Behavioural | CBT-Based Weight Loss Model |
| ControlTreatment as usual | Behavioural | Control |
Primary outcome
Change in Weight
Time frame: baseline and change from baseline to 1 year and 2 years
Measured by scale on baseline, 1 year and 2 years
Change in Lipids
Time frame: 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
Time frame: baseline and change from baseline to 1 year and 2 years
Measured by laboratory analyses
Change in c-reactive protein level
Time frame: baseline and change from baseline to 1 year and 2 years
Measured by laboratory analyses
Change in Glycated hemoglobin (HbA1c)
Time frame: baseline and change from baseline to 1 year and 2 years
Measured by laboratory analyses
Change in Waist circumference
Time frame: baseline and change from baseline to 1 year and 2 years
Measured by tape measure on baseline, 1 year and 2 years
12 secondary outcomes
Change in Eating behavior assessed by TFEQ-18 questionnaire
Time frame: baseline and change from baseline to 1 year and 2 years
Change in Eating behavior assessed by BES-questionnaire
Time frame: baseline and change from baseline to 1 year and 2 years
Change in Intuitive Eating behavior
Time frame: baseline and change from baseline to 1 year and 2 years
Change in Physical acitivity
Time frame: baseline and change from baseline to 1 year and 2 years
Change in Sleep
Time frame: baseline and change from baseline to 1 year and 2 years
Change in Use of alcohol and tobacco
Time frame: baseline and change from baseline to 1 year and 2 years
Previous weight loss
Time frame: baseline
Change in Mood
Time frame: baseline and change from baseline to 1 year and 2 years
Change in Anxiety
Time frame: baseline and change from baseline to 1 year and 2 years
Change in Quality of life
Time frame: baseline and change from baseline to 1 year and 2 years
Change in Self-efficacy: questionnaire
Time frame: baseline and change from baseline to 1 year and 2 years
Change in Sense of coherence
Time frame: baseline and change from baseline to 1 year and 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna-Maria Teeriniemi, PhD principal investigator
Kuopio University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-based weight loss model in people with Obesity and Depression, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna-Maria Teeriniemi, PhD (+358447113148, anna-maria.teeriniemi@kuh.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Weight (time frame: baseline and change from baseline to 1 year and 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.