Guided Imagery Intervention for Obese Latino Adolescents
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
- 是
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
Marc Weigensberg
Associate Professor
University of Southern California