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临床试验/NCT01403558
NCT01403558已完成不适用

Personality and Eating Behaviors in Morbidly Obese Patients

Sykehuset i Vestfold HF4 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
102
试验地点
4
主要终点
Change Affective symptoms

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have been accepted for bariatric surgery

排除标准

  • Patients suffering from drug and/or alcohol addiction.

结局指标

主要结局

Change Affective symptoms

时间窗: 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

Change Eating behaviours

时间窗: 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)

次要结局

  • Body weight - digital scale(As for primary outcome)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hege Gade

PhD student

Sykehuset i Vestfold HF

研究点 (4)

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