Personality and Eating Behaviors in Morbidly Obese Patients (PSYMO)

April 15, 2020 updated by: Hege Gade, Sykehuset i Vestfold HF

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Tønsberg, Norway, 3103
        • Senter for sykelig overvekt i Helse Sør-Øst, Sykehuset i Vestfold
    • Vestfold
      • Tønsberg, Vestfold, Norway, 3103
        • Hege Gade

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who have been accepted for bariatric surgery

Exclusion Criteria:

  • Patients suffering from drug and/or alcohol addiction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight - digital scale
Time Frame: As for primary outcome
Body weight - digital scale (Soehnle Professional 2755)
As for primary outcome

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 and 4 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sykehuset i Vestfold HF

Collaborators

University of Tromso

Investigators

  • Principal Investigator: Jøran Hjelmesæth, PhD, Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

June 7, 2011

First Submitted That Met QC Criteria

July 26, 2011

First Posted (Estimate)

July 27, 2011

Study Record Updates

Last Update Posted (Actual)

April 20, 2020

Last Update Submitted That Met QC Criteria

April 15, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/2071a

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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