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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.
 
ClinicalTrials.gov Identifier: NCT01403558
Recruitment Status : Completed
First Posted : July 27, 2011
Last Update Posted : April 20, 2020
Sponsor:
Collaborator:
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 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.

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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
Actual Primary Completion Date : March 2020
Actual Study Completion Date : April 2020

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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)

  2. 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


Secondary Outcome Measures :
  1. Body weight - digital scale [ Time Frame: As for primary outcome ]
    Body weight - digital scale (Soehnle Professional 2755)


Other Outcome Measures:
  1. 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



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

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 ClinicalTrials.gov identifier (NCT number): NCT01403558


Locations
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Norway
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
Investigators
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Principal Investigator: Jøran Hjelmesæth, PhD Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hege Gade, PhD student, Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier: NCT01403558    
Other Study ID Numbers: 2010/2071a
First Posted: July 27, 2011    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Affective Symptoms
Behavioral Symptoms