Eating BehaviorsPSYMONCT01403558
Personality and Eating Behaviors in Morbidly Obese Patients
A study testing Cognitive behavioral therapy in people with Eating Behaviors and Affective Symptoms, run by Sykehuset i Vestfold HF at 2 sites in Norway.
Trial summary
The aim of this randomized controlled trial is assess the effect of a psychological based treatment model on eating behaviors and motivation for lifestyle changes in morbidly obese patients undergoing bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eating Behaviors, Affective Symptoms
- What is being tested?
- Cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesNorway
- Study dates
- Sep 2011to Apr 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have been accepted for bariatric surgery
Who cannot join
- Patients suffering from drug and/or alcohol addiction.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Hege Gade
Tønsberg, Vestfold, 3103
Senter for sykelig overvekt i Helse Sør-Øst, Sykehuset i Vestfold
Tønsberg, 3103
About this study
The aim of this randomized controlled trial is assess the effect of a psychological based treatment model on eating behaviors and motivation for lifestyle changes in morbidly obese patients undergoing bariatric surgery.
Hypothesis: As compared with usual care, Cognitive Behavioral Therapy and Motivational interviewing-based (CBT/MI) intervention program will reduce dysfunctional eating behaviors and increase pre-surgical intrinsic motivation for lifestyle changes.
Read the detailed description
Obesity is usually treated as a medical disease, prescribing interventions which adhere to the theoretically sound principles.The prevalence of obesity is increasing, and, accordingly, an increasing number of morbidly obese patients are eligible for Bariatric Surgery. This surgical procedure is highly effective and is often followed by resolution or remission of obesity related comorbidities (e.g. diabetes and obstructive sleep apnea). However, some individuals may have psychological and motivational problems that reduce these beneficial effects. Bariatric surgery represents a substantial part of total health care costs, and such costs may increase in the future. Another issue is that it is important to prevent post-surgical relapses. Hence, there is every reason to increase the effect and efficacy of both conservative treatments and bariatric surgery.
Clinically the investigators meet patients who regain their weight post-surgically, and the investigators have some experience that these patients may display more dysfunctional eating than those who are able to maintain a lower target weight. Given the expected outcome of the RCT, the autonomous motivation for lifestyle changes will be increased. Lowering dysfunctional eating, as well as increasing the probability of better success in preoperative weight loss, may help the patient to maintain a healthier weight after the surgical procedure. Moreover, developing a more tailored intervention for surgery patients may enable new evidence based treatments to be established for these patients.
- Conditions
- Eating Behaviors, Affective Symptoms
- Being tested
- Cognitive behavioral therapy
- Medical subject headings
- Feeding Behavior, Affective Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapyBehavioural
Cognitive behavioral therapy
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioral therapy | Experimental | Ten weekly individual cognitive behavioral therapy sessions before bariatric surgery Receives: Behavioral: Cognitive behavioral therapy |
| Control group | No intervention | Usual preoperative care consisting of up to three voluntary sessions with nutritionist and physiotherapist before bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Eating behaviours
Eating behaviors: We will assess emotional eating, uncontrolled eating and Primary outcomes will be scored on the subscales "emotional eating" and "uncontrolled eating" on the TFEQ-R21. The predetermined criterion for clinically important improvement at 12 weeks will be a decrease of 15% from baseline on the emotional eating and uncontrolled eating subscale (range 0 to 100)
Measured: This co-primary outcome will be assessed, first, one week before the start of the 10 weeks intervention, and second, 1 week after the termination of the 10-weeks intervention. In addition a 1 and 4 year follow-up have been performed
Change Affective symptoms
Affective symptoms will be assessed With the HADS
Measured: This co-primary outcome will be assessed, first, one week before the start of the 10 weeks intervention, and second, 1 week after the termination of the 10-weeks intervention. In addition a 1 and 4 year follow-up have been performed
Secondary outcomes (1)
Body weight - digital scale
Body weight - digital scale (Soehnle Professional 2755)
Measured: As for primary outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2020
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Eating BehaviorsStudies 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset i Vestfold HF
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tromso
- Responsible party
- Principal investigator, Hege Gade, Sykehuset i Vestfold HF
- Investigators
- Jøran Hjelmesæth, PhD, Principal investigator, Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403558
- Sponsor's protocol ID
- 2010/2071a
- Acronym
- PSYMO
- Status last verified
- Apr 2020
- First submitted
- 7 Jun 2011
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Hjelmesaeth J, Rosenvinge JH, Gade H, Friborg O. Effects of Cognitive Behavioral Therapy on Eating Behaviors, Affective Symptoms, and Weight Loss After Bariatric Surgery: a Randomized Clinical Trial. Obes Surg. 2019 Jan;29(1):61-69. doi: 10.1007/s11695-018-3471-x.
PubMed 30112603Gade H, Friborg O, Rosenvinge JH, Smastuen MC, Hjelmesaeth J. The Impact of a Preoperative Cognitive Behavioural Therapy (CBT) on Dysfunctional Eating Behaviours, Affective Symptoms and Body Weight 1 Year after Bariatric Surgery: A Randomised Controlled Trial. Obes Surg. 2015 Nov;25(11):2112-9. doi: 10.1007/s11695-015-1673-z.
PubMed 25893651Gade H, Hjelmesaeth J, Rosenvinge JH, Friborg O. Effectiveness of a cognitive behavioral therapy for dysfunctional eating among patients admitted for bariatric surgery: a randomized controlled trial. J Obes. 2014;2014:127936. doi: 10.1155/2014/127936. Epub 2014 Jul 21.
PubMed 25147733Gade H, Rosenvinge JH, Hjelmesaeth J, Friborg O. Psychological correlates to dysfunctional eating patterns among morbidly obese patients accepted for bariatric surgery. Obes Facts. 2014;7(2):111-9. doi: 10.1159/000362257. Epub 2014 Mar 29.
PubMed 24685661
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personality and Eating Behaviors in Morbidly Obese Patients
- ClinicalTrials.gov ID
- NCT01403558
- Acronym / sponsor ID
- PSYMO / 2010/2071a
- Conditions
- Eating Behaviors, Affective Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Sykehuset i Vestfold HFUniversity, hospital or other
- Collaborators
- University of Tromso
- Study start
- Sep 2011
- Primary completion
- Mar 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 27 Jul 2011 (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 aim of this randomized controlled trial is assess the effect of a psychological based treatment model on eating behaviors and motivation for lifestyle changes in morbidly obese patients undergoing bariatric surgery.
Hypothesis: As compared with usual care, Cognitive Behavioral Therapy and Motivational interviewing-based (CBT/MI) intervention program will reduce dysfunctional eating behaviors and increase pre-surgical intrinsic motivation for lifestyle changes.
Detailed description
Obesity is usually treated as a medical disease, prescribing interventions which adhere to the theoretically sound principles.The prevalence of obesity is increasing, and, accordingly, an increasing number of morbidly obese patients are eligible for Bariatric Surgery. This surgical procedure is highly effective and is often followed by resolution or remission of obesity related comorbidities (e.g. diabetes and obstructive sleep apnea). However, some individuals may have psychological and motivational problems that reduce these beneficial effects. Bariatric surgery represents a substantial part of total health care costs, and such costs may increase in the future. Another issue is that it is important to prevent post-surgical relapses. Hence, there is every reason to increase the effect and efficacy of both conservative treatments and bariatric surgery.
Clinically the investigators meet patients who regain their weight post-surgically, and the investigators have some experience that these patients may display more dysfunctional eating than those who are able to maintain a lower target weight. Given the expected outcome of the RCT, the autonomous motivation for lifestyle changes will be increased. Lowering dysfunctional eating, as well as increasing the probability of better success in preoperative weight loss, may help the patient to maintain a healthier weight after the surgical procedure. Moreover, developing a more tailored intervention for surgery patients may enable new evidence based treatments to be established for these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral therapy | Experimental | Behavioral: Cognitive behavioral therapyTen weekly individual cognitive behavioral therapy sessions before bariatric surgery |
| Control group | No intervention | –Usual preoperative care consisting of up to three voluntary sessions with nutritionist and physiotherapist before bariatric surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have been accepted for bariatric surgery
Key exclusion criteria (1 listed)
- Patients suffering from drug and/or alcohol addiction.
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 therapyCognitive behavioral therapy | Behavioural | Cognitive behavioral therapy |
Primary outcome
Change Eating behaviours
Time frame: This co-primary outcome will be assessed, first, one week before the start of the 10 weeks intervention, and second, 1 week after the termination of the 10-weeks intervention. In addition a 1 and 4 year follow-up have been performed
Eating behaviors: We will assess emotional eating, uncontrolled eating and Primary outcomes will be scored on the subscales "emotional eating" and "uncontrolled eating" on the TFEQ-R21. The predetermined criterion for clinically important improvement at 12 weeks will be a decrease of 15% from baseline on the emotional eating and uncontrolled eating subscale (range 0 to 100)
Change Affective symptoms
Time frame: This co-primary outcome will be assessed, first, one week before the start of the 10 weeks intervention, and second, 1 week after the termination of the 10-weeks intervention. In addition a 1 and 4 year follow-up have been performed
Affective symptoms will be assessed With the HADS
1 secondary outcome
Body weight - digital scale
Time frame: As for primary outcome
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 20 Apr 2020.
- Derived from this study: PubMed 30112603Hjelmesaeth J, Rosenvinge JH, Gade H, Friborg O. Effects of Cognitive Behavioral Therapy on Eating Behaviors, Affective Symptoms, and Weight Loss After Bariatric Surgery: a Randomized Clinical Trial. Obes Surg. 2019 Jan;29(1):61-69. doi: 10.1007/s11695-018-3471-x.
- Derived from this study: PubMed 25893651Gade H, Friborg O, Rosenvinge JH, Smastuen MC, Hjelmesaeth J. The Impact of a Preoperative Cognitive Behavioural Therapy (CBT) on Dysfunctional Eating Behaviours, Affective Symptoms and Body Weight 1 Year after Bariatric Surgery: A Randomised Controlled Trial. Obes Surg. 2015 Nov;25(11):2112-9. doi: 10.1007/s11695-015-1673-z.
- Derived from this study: PubMed 25147733Gade H, Hjelmesaeth J, Rosenvinge JH, Friborg O. Effectiveness of a cognitive behavioral therapy for dysfunctional eating among patients admitted for bariatric surgery: a randomized controlled trial. J Obes. 2014;2014:127936. doi: 10.1155/2014/127936. Epub 2014 Jul 21.
- Derived from this study: PubMed 24685661Gade H, Rosenvinge JH, Hjelmesaeth J, Friborg O. Psychological correlates to dysfunctional eating patterns among morbidly obese patients accepted for bariatric surgery. Obes Facts. 2014;7(2):111-9. doi: 10.1159/000362257. Epub 2014 Mar 29.
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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.
Jøran Hjelmesæth, PhD principal investigator
Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway
2 sites 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 in people with Eating Behaviors and Affective Symptoms, run by Sykehuset i Vestfold HF at 2 sites in Norway.
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 1 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 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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 Eating behaviours (time frame: This co-primary outcome will be assessed, first, one week before the start of the 10 weeks intervention, and second, 1 week after the termination of the 10-weeks intervention. In addition a 1 and 4 year follow-up have been performed). The study lists 2 primary outcomes in all. 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 NCT01403558, which also lists 4 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 20 Apr 2020.