ObesityCognObeNCT01606904
The Effect of CBT- Based Weight Loss Program on Obesity
A study testing Cognitive behavioral therapy -based weight loss program in people with Obesity and Hypercholesterolemia, run by University of Oulu at 1 site in Finland.
Trial summary
The investigators purpose is to study how CBT (cognitive behavioral therapy)-based weight loss program affects on eating behavior, weight loss and risk factors for CHD (coronary heart diseases)and type 2 diabetes. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Obesity, Hypercholesterolemia, Diabetes Mellitus, Type 2
- What is being tested?
- Cognitive behavioral therapy -based weight loss program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFinland
- Study dates
- May 2012to Mar 2016
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI > 30
Who cannot join
- other concurrent weight loss programs
- disease which prevents weight loss
- medication which affects on weight loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of CBT- Based Weight Loss Program on Eating Behavior, Weight Loss Result and Risk for Coronary Heart Diseases and Type 2 Diabetes
The investigators purpose is to study how CBT (cognitive behavioral therapy)-based weight loss program affects on eating behavior, weight loss and risk factors for CHD (coronary heart diseases)and type 2 diabetes. Moreover, the investigators aim is to recognize subjects suffering from anhedonia (one of the core symptoms of depression, lack of pleasure) and follow how they benefit from the program in order to achieve maintained weight loss. Also, the associations between weight loss, physical activity and musculoskeletal disorders are studied.
Read the detailed description
Obesity is an increasing problem and effective weight loss methods are needed. The study is randomized follow-up study with 9 months intervention and three (3) years follow-up period. The study is organized in Oulu University Hospital, Department of Internal Medicine. Eighty (80)obese, 20-65 years, study subjects will be randomized into intervention or control group.
The hypothesis of the CognObe study is: CBT (cognitive behavioral therapy)-based weight loss program is successful in sustained and favourable change in eating behavior and weight as well as decreased risk for coronary heart diseases or type 2 diabetes.
- Conditions
- Obesity, Hypercholesterolemia, Diabetes Mellitus, Type 2, Anhedonia
- Being tested
- Cognitive behavioral therapy -based weight loss program
- Medical subject headings
- Obesity, Hypercholesterolemia, Diabetes Mellitus, Type 2, Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy -based weight loss programBehavioural
CBT-based program includes 20 group visits
| Study group | Role | What they receive |
|---|---|---|
| Weight loss counseling | Experimental | Cognitive behavioral therapy - based weight loss program Receives: Behavioral: Cognitive behavioral therapy -based weight loss program |
| Control | Other | Short term weight loss counseling, control group Receives: Behavioral: Cognitive behavioral therapy -based weight loss program |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in weight
kilograms
Measured: baseline, 9 months, 1,2 and 3 years
Secondary outcomes (4)
change in eating behavior
emotional eating, uncontrolled eating, cognitive restraint, binge eating symptoms
Measured: baseline, 9 months, 1,2 and 3 years
change in total cholesterol,HDL, LDL,Trigly and glucose
change in laboratory values
Measured: baseline, 1,2 and 3 years
DNA
for genetic analyses
Measured: baseline
change in incretins
change in incretins
Measured: baseline, 12, 24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2012 (estimated)
- Study startMay 2012
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Juho Vainio Foundation, Yrjo Jahnsson Foundation, Oulu University Hospital
- Responsible party
- Principal investigator, Anna-Maria Keränen, University of Oulu
- Investigators
- Anna-Maria Teeriniemi (nee Keränen), Principal investigator, Oulun University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606904
- Sponsor's protocol ID
- 58/2012
- Acronym
- CognObe
- Status last verified
- May 2018
- First submitted
- 21 May 2012
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Keranen AM, Savolainen MJ, Reponen AH, Kujari ML, Lindeman SM, Bloigu RS, Laitinen JH. The effect of eating behavior on weight loss and maintenance during a lifestyle intervention. Prev Med. 2009 Aug;49(1):32-8. doi: 10.1016/j.ypmed.2009.04.011. Epub 2009 May 4.
PubMed 19406146Keranen AM, Strengell K, Savolainen MJ, Laitinen JH. Effect of weight loss intervention on the association between eating behaviour measured by TFEQ-18 and dietary intake in adults. Appetite. 2011 Feb;56(1):156-62. doi: 10.1016/j.appet.2010.10.004. Epub 2010 Oct 16.
PubMed 20955744Keranen AM, Rasinaho E, Hakko H, Savolainen M, Lindeman S. Eating behavior in obese and overweight persons with and without anhedonia. Appetite. 2010 Dec;55(3):726-9. doi: 10.1016/j.appet.2010.08.012. Epub 2010 Aug 27.
PubMed 20801180
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of CBT- Based Weight Loss Program on Eating Behavior, Weight Loss Result and Risk for Coronary Heart Diseases and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01606904
- Acronym / sponsor ID
- CognObe / 58/2012
- Conditions
- Obesity, Hypercholesterolemia, Diabetes Mellitus, Type 2, Anhedonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Juho Vainio Foundation, Yrjo Jahnsson Foundation, Oulu University Hospital
- Study start
- May 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 28 May 2012 (estimated)
- 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 investigators purpose is to study how CBT (cognitive behavioral therapy)-based weight loss program affects on eating behavior, weight loss and risk factors for CHD (coronary heart diseases)and type 2 diabetes. Moreover, the investigators aim is to recognize subjects suffering from anhedonia (one of the core symptoms of depression, lack of pleasure) and follow how they benefit from the program in order to achieve maintained weight loss. Also, the associations between weight loss, physical activity and musculoskeletal disorders are studied.
Detailed description
Obesity is an increasing problem and effective weight loss methods are needed. The study is randomized follow-up study with 9 months intervention and three (3) years follow-up period. The study is organized in Oulu University Hospital, Department of Internal Medicine. Eighty (80)obese, 20-65 years, study subjects will be randomized into intervention or control group.
The hypothesis of the CognObe study is: CBT (cognitive behavioral therapy)-based weight loss program is successful in sustained and favourable change in eating behavior and weight as well as decreased risk for coronary heart diseases or type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight loss counseling | Experimental | Behavioral: Cognitive behavioral therapy -based weight loss programCognitive behavioral therapy - based weight loss program |
| Control | Other | Behavioral: Cognitive behavioral therapy -based weight loss programShort term weight loss counseling, control group |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI > 30
Key exclusion criteria (3 listed)
- other concurrent weight loss programs
- disease which prevents weight loss
- medication which affects on weight loss
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 |
|---|---|---|
| Cognitive behavioral therapy -based weight loss programCBT-based program includes 20 group visits | Behavioural | Control, Weight loss counseling |
Primary outcome
change in weight
Time frame: baseline, 9 months, 1,2 and 3 years
kilograms
4 secondary outcomes
change in eating behavior
Time frame: baseline, 9 months, 1,2 and 3 years
change in total cholesterol,HDL, LDL,Trigly and glucose
Time frame: baseline, 1,2 and 3 years
DNA
Time frame: baseline
change in incretins
Time frame: baseline, 12, 24 and 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Background: PubMed 19406146Keranen AM, Savolainen MJ, Reponen AH, Kujari ML, Lindeman SM, Bloigu RS, Laitinen JH. The effect of eating behavior on weight loss and maintenance during a lifestyle intervention. Prev Med. 2009 Aug;49(1):32-8. doi: 10.1016/j.ypmed.2009.04.011. Epub 2009 May 4.
- Background: PubMed 20955744Keranen AM, Strengell K, Savolainen MJ, Laitinen JH. Effect of weight loss intervention on the association between eating behaviour measured by TFEQ-18 and dietary intake in adults. Appetite. 2011 Feb;56(1):156-62. doi: 10.1016/j.appet.2010.10.004. Epub 2010 Oct 16.
- Background: PubMed 20801180Keranen AM, Rasinaho E, Hakko H, Savolainen M, Lindeman S. Eating behavior in obese and overweight persons with and without anhedonia. Appetite. 2010 Dec;55(3):726-9. doi: 10.1016/j.appet.2010.08.012. Epub 2010 Aug 27.
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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 (nee Keränen) principal investigator
Oulun 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 Cognitive behavioral therapy -based weight loss program in people with Obesity and Hypercholesterolemia, run by University of Oulu 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 11 May 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in weight (time frame: baseline, 9 months, 1,2 and 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01606904, which also lists 3 linked publications.
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 11 May 2018.