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临床试验/NCT01895595
NCT01895595已完成不适用

Guided Imagery Intervention for Obese Latino Adolescents

University of Southern California2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2007年1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
51
试验地点
2
主要终点
Insulin sensitivity/resistance

研究概览

简要总结

Guided imagery, a mind-body complementary/alternative treatment modality, offers promise to reduce stress and promote lifestyle behavior change to reduce diabetes and heart disease risk in obese Latino adolescents. The overall purpose of this study was to determine whether guided imagery, could reduce diabetes risk in obese Latino adolescents undergoing a lifestyle intervention. The specific objectives were: 1) To pilot test a new 12-week lifestyle intervention in obese Latino adolescents, in order to determine the effects of the mind-body technique of Interactive Guided ImagerySM, over and above those of healthy lifestyle education, on eating and physical activity behaviors, stress and stress biomarkers, and hormonal markers of diabetes risk; and 2) To explore the way that changes in stress produced by the intervention were associated with changes in hormonal markers of diabetes risk, particularly insulin resistance. The investigators hypothesized that participants who received guided imagery program in addition to the healthy lifestyle education would show greater improvements in insulin resistance, physical activity, dietary intake, and stress, than those receiving the healthy lifestyle education without the guided imagery. The investigators further hypothesized that reductions in stress due to the intervention would be associated with improvements in insulin resistance, a major hormonal marker of diabetes risk. For this study, obese, Latino adolescents (age 14-17) were randomized to receive either 12 weekly sessions of the lifestyle education plus guided imagery program, or lifestyle education plus a digital storytelling computer program (as a control). Outcome measures were assessed before and after the 12-week intervention, comparing the differences between the intervention groups behavioral (eating and physical activity behaviors), biological (insulin resistance and stress hormones), and psychological (stress) outcomes.

详细描述

The current proposal pilot tests the investigators' guided imagery intervention in a limited sample of subjects in order to refine the intervention (Study 1) and then proceeds to test the intervention in a controlled, randomized trial (Study 2).

Study 1: Pilot test and refinement of guided imagery program

Specific Aim 1: To pilot, evaluate, and complete development of a guided imagery intervention program based on stress reduction and improving lifestyle behaviors for use with overweight Latino adolescents.

Outcome Objectives: Findings from Study 1 will permit us to test the intervention via a controlled, randomized trial in Study 2.

Study Design The guided imagery intervention program will be combined with a lifestyle education program and will be piloted, one module weekly for 12 weeks, in 8 overweight Latino adolescents (4 males, 4 females). Upon completion of the pilot intervention, participants will participate in an idea-building session about their experiences with the program, in order to develop ideas to add to or modify the program. Participants will discuss the acceptability, cultural relevance, developmental appropriateness and obstacles to efficacy and delivery of the program. The information from these sessions will be analyzed in order to improve the intervention's developmental and cultural relevance and appeal. Analyses of the idea-building data will be similar to analyses used for focus group data, including recording, transcription, and examination of the data for emergent themes. Based on information obtained during the pilot study and from the idea-building sessions, the program will be modified for the intervention study, Study 2.

研究设计

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

入排标准

年龄范围
14 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Insulin sensitivity/resistance

时间窗: Baseline and 12-weeks (post-intervention)

Insulin sensitivity measured by the frequently sampled IV glucose tolerance test; insulin resistance measured by HOMA insulin resistance index

次要结局

  • Physical activity(Baseline and 12-weeks (post-intervention))
  • Dietary intake(Baseline and 12-weeks (post-intervention))

研究者

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

Marc Weigensberg

Associate Professor

University of Southern California

研究点 (2)

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