Personality and Eating Behaviors in Morbidly Obese Patients (PSYMO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01403558
Recruitment Status : Active, not recruiting
First Posted : July 27, 2011
Last Update Posted : May 10, 2017
University of Tromso
Information provided by (Responsible Party):
Hege Gade, Sykehuset i Vestfold HF

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.

Condition or disease Intervention/treatment Phase
Eating Behaviors Affective Symptoms Behavioral: Cognitive behavioral therapy with motivational interwiewing Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Personality and Eating Behaviors in Morbidly Obese Patients
Study Start Date : September 2011
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: CBT (with MI)
Ten weekly individual sessions before bariatric surgery aiming to improve dysfunctional eating behaviors
Behavioral: Cognitive behavioral therapy with motivational interwiewing
CBT combined With MI

No Intervention: Control group
Usual care consisting of up to three voluntary sessions with nutritionist and physiotherapist
No Intervention: 4 years follow-up
4 years follow-up of the intervention group

Primary Outcome Measures :
  1. Changes in eating behavior and affective symptoms 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 ]

    Eating behaviors: We will assess emotional eating, uncontrolled eating and cognitive restraint. The aim of the trial is to reduce 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)

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who have been accepted for bariatric surgery

Exclusion Criteria:

  • Patients suffering from drug and/or alcohol addiction.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01403558

Hege Gade
Tønsberg, Vestfold, Norway, 3103
Senter for sykelig overvekt i Helse Sør-Øst, Sykehuset i Vestfold
Tønsberg, Norway, 3103
Sponsors and Collaborators
Sykehuset i Vestfold HF
University of Tromso
Principal Investigator: Jøran Hjelmesæth, PhD Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hege Gade, PhD student, Sykehuset i Vestfold HF Identifier: NCT01403558     History of Changes
Other Study ID Numbers: 2010/2071a
First Posted: July 27, 2011    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Affective Symptoms
Behavioral Symptoms