Affective Symptoms Clinical Trial
— PSYMOOfficial title:
Personality and Eating Behaviors in Morbidly Obese Patients
NCT number | NCT01403558 |
Other study ID # | 2010/2071a |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2011 |
Est. completion date | April 2020 |
Verified date | April 2020 |
Source | Sykehuset i Vestfold HF |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 102 |
Est. completion date | April 2020 |
Est. primary completion date | March 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients who have been accepted for bariatric surgery Exclusion Criteria: - Patients suffering from drug and/or alcohol addiction. |
Country | Name | City | State |
---|---|---|---|
Norway | Hege Gade | Tønsberg | Vestfold |
Norway | Senter for sykelig overvekt i Helse Sør-Øst, Sykehuset i Vestfold | Tønsberg |
Lead Sponsor | Collaborator |
---|---|
Sykehuset i Vestfold HF | University of Tromso |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Health related quality of life - impact of weight on quality of life (IWQOL-lite) | 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 | |
Primary | Change Eating behaviours | 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 | |
Primary | Change Affective symptoms | 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 | Body weight - digital scale | Body weight - digital scale (Soehnle Professional 2755) | As for primary outcome |
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