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临床试验/NCT00548652
NCT00548652已完成不适用

Role of Apathy in the Effectiveness of Weight Loss Interventions in Obese Patients

VA Nebraska Western Iowa Health Care System1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2007年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
101
试验地点
1
主要终点
Apathy Evaluation Scale

研究概览

简要总结

The purpose of this study is to determine whether treating apathy with methylphenidate or medical Crisis counselling will increase adherence to weight loss programs thereby increasing their effectiveness

详细描述

Title: The role of Apathy in the effectiveness of weight loss interventions in obese patients

Objective

Obesity is a major public health problem. Apathy is a common behavioral problem characterized by loss of initiative, poor motivation and persistence. Presence of apathy impairs the self-care behavior in obese patients. Lack of novelty might impair a patient's ability to seek new interactions, life styles and new treatment options for obesity. Lack of motivation might impair a patient's ability to initiate exercise regimen or diet whereas lack of persistence impairs the compliance with these regimens. Thus, apathy influences all stages of self-care. We hypothesize that the treatment of apathy will result in better adherence to weight loss interventions in obese veterans enrolled in the MOVE program.

Research Design: A prospective open label randomized study. Group 1 will have patients with obesity as defined as BMI>30, and apathy defined as AES score of > 40. This group will be treated with standard nutrition counseling. Group 2 will have patients with obesity and apathy as defined above and will receive the MOVE enhancement program alone (The MOVE program is a national VA weight loss program). Group 3 will be treated with methylphenidate along with the MOVE enhancement program. Group 4 will be treated with medical crisis counseling along with the MOVE enhancement program. Group 5 will be treated with methylphenidate, and the medical crisis counseling along with the MOVE enhancement program.

Methodology: 30 patients meeting the criteria will be enrolled in each of the five arms. All patients will be in the study for duration of six months. All patients in the methylphenidate arm will be started at 5mg twice daily and titrated to 10mg twice daily at two weeks. Patients will be assessed on regular intervals using the Apathy Evaluation Scale, Hamilton Depression Scale and the Patient activation measure. MOVE sessions will be held once weekly from the 2nd visit to the end of the study. Medical Crisis Counseling visits will be every week for nine sessions and then every other week till the end of the study

Clinical Relationships/Significance: The prevalence of obesity in the general population is over 30%. However the prevalence of obesity in the VA health system is almost 70%. Since obesity predisposes to several co-morbid conditions such as hypertension, diabetes and cardiovascular disease, it is important to develop interventions that are effective in inducing weight loss. Since apathy plays a large role in the self care behaviours that lead to obesity, treating apathy may improve adherence to weight loss programs

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
21 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Apathy score >40

排除标准

  • History of cancer, except basal cell
  • Cardiovascular event in last 6 months
  • Renal failure

研究组 & 干预措施

3

Experimental

MOVE plus medical crisis counselling

干预措施: MOVE (Behavioral)

2

Experimental

MOVE -weight loss intervention

干预措施: MOVE (Behavioral)

3

Experimental

MOVE plus medical crisis counselling

干预措施: medical crisis councelling (Behavioral)

4

Experimental

MOVE plus methylphenidate

干预措施: methyphenidate (Drug)

4

Experimental

MOVE plus methylphenidate

干预措施: MOVE (Behavioral)

5

Experimental

MOVE plus methyphenidate plus medical crisis counselling

干预措施: methyphenidate (Drug)

5

Experimental

MOVE plus methyphenidate plus medical crisis counselling

干预措施: medical crisis councelling (Behavioral)

5

Experimental

MOVE plus methyphenidate plus medical crisis counselling

干预措施: MOVE (Behavioral)

结局指标

主要结局

Apathy Evaluation Scale

时间窗: 6 months

Apathy Evaluation Scale (AES) measures apathy over the previous four weeks Scale range: 18 (minimum score)- 72 (Maximum score) Higher scores indicate higher apathy Better outcome would be reduction in the score

次要结局

  • Change in Weight(6 months)

研究者

发起方
VA Nebraska Western Iowa Health Care System
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Prasad R. Padala

Staff Physician

VA Nebraska Western Iowa Health Care System

研究点 (1)

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