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临床试验/NCT00158366
NCT00158366已完成不适用

A Clinical Trial Of Weight Reduction in Schizophrenia

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 261 人开始时间: 2004年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
261
试验地点
1
主要终点
Weight reduction

研究概览

简要总结

This study will determine the effectiveness of a group-based behavioral program for weight reduction in overweight and obese schizophrenia patients.

详细描述

Researchers have found a link between schizophrenia, high blood pressure, and insulin resistance; this link puts people with schizophrenia at an increased risk for diabetes and obesity. Weight reduction and maintenance is essential for decreasing these risks. Although data indicate that nonpharmacological interventions for weight loss are viable options, studies to determine their effectiveness have not been conducted. This study will determine the effectiveness of behavioral training for reducing weight in schizophrenia patients. This study will also determine the effects of weight reduction on cardiovascular risk factors in this population.

This study comprises two phases. In Phase 1, participants will be randomly assigned to receive either behavioral training or social skills training for 14 weeks. The behavioral training will teach participants ways to control their diet and increase their physical activity. The social skills training will teach participants how to indirectly control their weight by making social contacts and seeking social support. After 14 weeks, participants in the social skills training group and any participants who have not lost a specified amount of weight will complete the study; participants in the behavioral training group who have a 4% or more weight loss will be enrolled in Phase 2, a 24-month program designed to help participants maintain their weight loss. All participants in Phase 2 will continue to receive weekly behavioral training, but they will be randomly assigned to receive either behavioral training alone or behavioral training combined with biweekly booster treatments where participants discuss their response to different diet and exercise regimens and researchers discuss strategies for increasing one's success with the regimens. Interviews, self-report scales, and blood tests will be used to assess participants at study entry, after Phase 1, and at the end of the study. Assessments will include quality of life, self esteem, exercise frequency, blood pressure, serum lipids, and blood glucose.

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
14 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosis of schizophrenia or schizoaffective disorder
  • •Body mass index (BMI) greater than 27
  • •Stable on antipsychotic drug regimen for at least 1 month prior to study entry
  • •Parent or guardian willing to provide informed consent, if applicable
  • •Positive and negative syndrome scale score less than 90
  • •Willing to use acceptable methods of contraception during the study

排除标准

  • •Medical contraindication for participating in a weight reduction/exercise program
  • •Mental retardation
  • •Current enrollment in another weight management program
  • •Current use of weight reduction medication
  • •Unstable cardiovascular or thyroid disease
  • •Active or end-stage renal disease
  • •Psychiatric hospitalization within 1 month prior to study entry
  • •Current use of more than one anti-psychotic medication
  • •Pregnancy or breastfeeding

研究组 & 干预措施

1

Experimental

Phase 1 participants who will receive behavioral training for 14 weeks

干预措施: Behavioral training (Behavioral)

2

Active Comparator

Phase 1 participants who will receive social skills training for 14 weeks

干预措施: Social skills training (Behavioral)

3

Experimental

Participants in the Phase 1 behavioral training group who have a 4% or more weight loss and will be enrolled in weekly behavioral training alone for 24 months in Phase 2

干预措施: Behavioral training (Behavioral)

4

Experimental

Participants in the Phase 1 behavioral training group who have a 4% or more weight loss and will be enrolled in weekly behavioral training plus biweekly booster treatments for 24 months in Phase 2

干预措施: Behavioral training booster sessions (Behavioral)

结局指标

主要结局

Weight reduction

时间窗: Measured at Week 14 and Month 24

次要结局

  • Weight maintenance(Measured at Week 14 and Month 24)

研究者

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

Rohan Ganguli

Professor of Psychiatry

University of Pittsburgh

研究点 (1)

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