Personality and Eating Behaviors in Morbidly Obese Patients (PSYMO)
Primary Purpose
Eating Behaviors, Affective Symptoms
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Cognitive behavioral therapy
Sponsored by
About this trial
This is an interventional treatment trial for Eating Behaviors
Eligibility Criteria
Inclusion Criteria:
- Patients who have been accepted for bariatric surgery
Exclusion Criteria:
- Patients suffering from drug and/or alcohol addiction.
Sites / Locations
- Hege Gade
- Senter for sykelig overvekt i Helse Sør-Øst, Sykehuset i Vestfold
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cognitive behavioral therapy
Control group
Arm Description
Ten weekly individual cognitive behavioral therapy sessions before bariatric surgery
Usual preoperative care consisting of up to three voluntary sessions with nutritionist and physiotherapist before bariatric surgery
Outcomes
Primary Outcome Measures
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)
Change Affective symptoms
Affective symptoms will be assessed With the HADS
Secondary Outcome Measures
Body weight - digital scale
Body weight - digital scale (Soehnle Professional 2755)
Full Information
NCT ID
NCT01403558
First Posted
June 7, 2011
Last Updated
April 15, 2020
Sponsor
Sykehuset i Vestfold HF
Collaborators
University of Tromso
1. Study Identification
Unique Protocol Identification Number
NCT01403558
Brief Title
Personality and Eating Behaviors in Morbidly Obese Patients
Acronym
PSYMO
Official Title
Personality and Eating Behaviors in Morbidly Obese Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
April 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sykehuset i Vestfold HF
Collaborators
University of Tromso
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Behaviors, Affective Symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive behavioral therapy
Arm Type
Experimental
Arm Description
Ten weekly individual cognitive behavioral therapy sessions before bariatric surgery
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual preoperative care consisting of up to three voluntary sessions with nutritionist and physiotherapist before bariatric surgery
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy
Intervention Description
Cognitive behavioral therapy
Primary Outcome Measure Information:
Title
Change Eating behaviours
Description
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)
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
Title
Change Affective symptoms
Description
Affective symptoms will be assessed With the HADS
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
Secondary Outcome Measure Information:
Title
Body weight - digital scale
Description
Body weight - digital scale (Soehnle Professional 2755)
Time Frame
As for primary outcome
Other Pre-specified Outcome Measures:
Title
Health related quality of life - impact of weight on quality of life (IWQOL-lite)
Description
Health related quality of life - impact of weight on quality of life (IWQOL-lite) is a 31-item questionnaire
Time Frame
1 and 4 years after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who have been accepted for bariatric surgery
Exclusion Criteria:
Patients suffering from drug and/or alcohol addiction.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jøran Hjelmesæth, PhD
Organizational Affiliation
Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hege Gade
City
Tønsberg
State/Province
Vestfold
ZIP/Postal Code
3103
Country
Norway
Facility Name
Senter for sykelig overvekt i Helse Sør-Øst, Sykehuset i Vestfold
City
Tønsberg
ZIP/Postal Code
3103
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
30112603
Citation
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.
Results Reference
derived
PubMed Identifier
25893651
Citation
Gade 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.
Results Reference
derived
PubMed Identifier
25147733
Citation
Gade 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.
Results Reference
derived
PubMed Identifier
24685661
Citation
Gade 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.
Results Reference
derived
Learn more about this trial
Personality and Eating Behaviors in Morbidly Obese Patients
We'll reach out to this number within 24 hrs