Personality and Eating Behaviors in Morbidly Obese Patients (PSYMO)
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|ClinicalTrials.gov Identifier: NCT01403558|
Recruitment Status : Completed
First Posted : July 27, 2011
Last Update Posted : April 20, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Eating Behaviors Affective Symptoms||Behavioral: Cognitive behavioral therapy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Personality and Eating Behaviors in Morbidly Obese Patients|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||March 2020|
|Actual Study Completion Date :||April 2020|
Experimental: Cognitive behavioral therapy
Ten weekly individual cognitive behavioral therapy sessions before bariatric surgery
Behavioral: Cognitive behavioral therapy
Cognitive behavioral therapy
No Intervention: Control group
Usual preoperative care consisting of up to three voluntary sessions with nutritionist and physiotherapist before bariatric surgery
- 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
- Body weight - digital scale [ Time Frame: As for primary outcome ]Body weight - digital scale (Soehnle Professional 2755)
- Health related quality of life - impact of weight on quality of life (IWQOL-lite) [ Time Frame: 1 and 4 years after surgery ]Health related quality of life - impact of weight on quality of life (IWQOL-lite) is a 31-item questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01403558
|Tønsberg, Vestfold, Norway, 3103|
|Senter for sykelig overvekt i Helse Sør-Øst, Sykehuset i Vestfold|
|Tønsberg, Norway, 3103|
|Principal Investigator:||Jøran Hjelmesæth, PhD||Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway|