Personality and Eating Behaviors in Morbidly Obese Patients
PSYMO
1 other identifier
interventional
102
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2011
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2011
CompletedFirst Posted
Study publicly available on registry
July 27, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedApril 20, 2020
April 1, 2020
8.5 years
June 7, 2011
April 15, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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)
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
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
As for primary outcome
Other Outcomes (1)
Health related quality of life - impact of weight on quality of life (IWQOL-lite)
1 and 4 years after surgery
Study Arms (2)
Cognitive behavioral therapy
EXPERIMENTALTen weekly individual cognitive behavioral therapy sessions before bariatric surgery
Control group
NO INTERVENTIONUsual preoperative care consisting of up to three voluntary sessions with nutritionist and physiotherapist before bariatric surgery
Interventions
Eligibility Criteria
You may qualify if:
- Patients who have been accepted for bariatric surgery
You may not qualify if:
- Patients suffering from drug and/or alcohol addiction.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sykehuset i Vestfold HFlead
- University of Tromsocollaborator
Study Sites (2)
Hege Gade
Tønsberg, Vestfold, 3103, Norway
Senter for sykelig overvekt i Helse Sør-Øst, Sykehuset i Vestfold
Tønsberg, 3103, Norway
Related Publications (4)
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.
PMID: 30112603DERIVEDGade 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.
PMID: 25893651DERIVEDGade 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.
PMID: 25147733DERIVEDGade 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.
PMID: 24685661DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jøran Hjelmesæth, PhD
Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD student
Study Record Dates
First Submitted
June 7, 2011
First Posted
July 27, 2011
Study Start
September 1, 2011
Primary Completion
March 1, 2020
Study Completion
April 1, 2020
Last Updated
April 20, 2020
Record last verified: 2020-04