Personality and Eating Behavior in Morbidly Obese Patients (PSYMO)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Sykehuset i Vestfold HF.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Tromso
Information provided by (Responsible Party):
Hege Gade, Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier:
NCT01403558
First received: June 7, 2011
Last updated: November 28, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Eating Behavior
Motivation
Behavioral: Psychological treatment
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Sykehuset i Vestfold HF:

Primary Outcome Measures:
  • 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)



Estimated Enrollment: 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)
Intervention Details:
    Behavioral: Psychological treatment
    MI combined with CBT
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01403558

Contacts
Contact: Hege Gade, PhD-fellow +47 90107590 hege.gade@siv.no
Contact: Jøran Hjelmesæth, PhD +47 40217349 joran.hjelmeseth@siv.no

Locations
Norway
Hege Gade Recruiting
Tønsberg, Vestfold, Norway, 3103
Contact: Hege HG Gade, Phd student    +47 33342336    hege.gade@siv.no   
Contact: Jøran JH Hjelmesæth, PhD    +47 40217349    joran.hjelmeseth@siv.no   
Senter for sykelig overvekt i Helse Sør-Øst, Sykehuset i Vestfold Not yet recruiting
Tønsberg, Norway, 3103
Contact: Hege Gade, PhD-fellow    +4790107590    hege.gade@siv.no   
Contact: Jøran Hjelmesæth, Dr.Med (PhD)         
Principal Investigator: Hege Gade, PhD-fellow         
Sponsors and Collaborators
Sykehuset i Vestfold HF
University of Tromso
Investigators
Principal Investigator: Jøran Hjelmesæth, PhD Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway
  More Information

No publications provided

Responsible Party: Hege Gade, PhD student, Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier: NCT01403558     History of Changes
Other Study ID Numbers: 2010/2071a
Study First Received: June 7, 2011
Last Updated: November 28, 2011
Health Authority: Norway: Ethics Committee

ClinicalTrials.gov processed this record on July 28, 2014