Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT01403558
Status:
COMPLETED
Last Update Posted:
2020-04-20
First Post:
2011-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Personality and Eating Behaviors in Morbidly Obese Patients
Sponsor:
Sykehuset i Vestfold HF
Organization:
Study Overview
Official Title:
Personality and Eating Behaviors in Morbidly Obese Patients
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PSYMO
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.
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: