Personality and Eating Behaviors in Morbidly Obese Patients

Affective Symptoms Clinical Trial

— PSYMO  

Official title:

Personality and Eating Behaviors in Morbidly Obese Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01403558
• Other study ID #: 2010/2071a
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: April 2020

Study information

• Verified date: April 2020
• Source: Sykehuset i Vestfold HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Affective Symptoms
• Eating Behaviors

Intervention

Behavioral:
• Cognitive behavioral therapy
Cognitive behavioral therapy

Locations

Country	Name	City	State
Norway	Hege Gade	Tønsberg	Vestfold
Norway	Senter for sykelig overvekt i Helse Sør-Øst, Sykehuset i Vestfold	Tønsberg

Sponsors (2)

Lead Sponsor	Collaborator
Sykehuset i Vestfold HF	University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

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