Personality and Eating Behavior in Morbidly Obese Patients (PSYMO)
Recruitment status was Recruiting
The aim of this randomized controlled trial is assess the effect of a psychological based treatment model on eating behavior and motivation for lifestyle changes in morbidly obese patients undergoing bariatric surgery.
Hypothesis: As compared with usual care, a Motivational Interviewing/Cognitive Behavioral Therapy-based (MI/CBT) intervention program will reduce the frequency of dysfunctional eating behavior and increase pre-surgical intrinsic motivation for lifestyle changes.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Personality and Eating Behavior in Morbidly Obese Patients|
- Changes in eating behavior and motivation after psychological intervention [ Time Frame: The 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 ] [ Designated as safety issue: No ]
Eating behavior: We will assess emotional eating, uncontrolled eating and cognitive restraint. The aim of the trial is to reduce the frequency of emotional- and uncontrolled eating behavior.
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)
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||November 2012|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Behavioral: Psychological treatment
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01403558
|Contact: Hege Gade, PhD-fellow||+47 firstname.lastname@example.org|
|Contact: Jøran Hjelmesæth, PhD||+47 email@example.com|
|Tønsberg, Vestfold, Norway, 3103|
|Contact: Hege HG Gade, Phd student +47 33342336 firstname.lastname@example.org|
|Contact: Jøran JH Hjelmesæth, PhD +47 40217349 email@example.com|
|Senter for sykelig overvekt i Helse Sør-Øst, Sykehuset i Vestfold||Not yet recruiting|
|Tønsberg, Norway, 3103|
|Contact: Hege Gade, PhD-fellow +4790107590 firstname.lastname@example.org|
|Contact: Jøran Hjelmesæth, Dr.Med (PhD)|
|Principal Investigator: Hege Gade, PhD-fellow|
|Principal Investigator:||Jøran Hjelmesæth, PhD||Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway|