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临床试验/NCT02535169
NCT02535169已完成不适用

Lifestyle-Related Health Outcomes in Prediabetes and Diabetes

Indiana University2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2014年5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
78
试验地点
2
主要终点
Changes in the oral disposition index measured by oral glucose tolerance test

研究概览

简要总结

This study looks as how a health education intervention strategy effects health outcomes in overweight and obese adolescents.

详细描述

This study aims to do the following:

  1. To evaluate whether a health education and coaching strategy in overweight and obese adolescents (≥85th percentile) with high risk for type 2 diabetes is superior to usual care (single nutrition consultation) for weight management, clinical health outcomes (measures of glucose tolerance), lifestyle behavior outcomes (diet and physical activity) and outcomes of importance to patients such as satisfaction with the health care team, treatment goals, and psychosocial functioning.
  2. To evaluate whether a health education and coaching strategy in obese adolescents with diabetes (type 1 or type 2) is superior to usual care (single nutrition consultation) for weight management, clinical health outcomes (measures of diabetes control), lifestyle behavior outcomes (diet and physical activity) and outcomes of importance to patients such as satisfaction with the health care team, treatment goals, and psychosocial functioning.
  3. At baseline, before the interventions described in Aims 1 and 2, to identify key diet and physical activity factors, patient characteristics, or biomarkers which are predictive of diabetes risk.
  4. At baseline, before the interventions described in Aims 1 and 2, can associations between glycemia, cardiometabolic risk factors, and diet and physical activity behaviors in overweight and obese adolescents who are at risk for type 2 diabetes be identified using the Bright Futures questionnaire, a survey for lifestyle behavior which is normally used in the clinic setting.

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
10 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • male and female adolescents/young adults,
  • Tanner stage II-V,
  • overweight or obese (body mass index ≥85th percentile for age and sex).

排除标准

  • use of medications that adversely affect glucose metabolism (such as glucocorticoid-containing medications or atypical antipsychotics), and
  • syndromic obesity (such as Prader Willi, hypothalamic obesity, or Laurence- Moon-Biedl).

结局指标

主要结局

Changes in the oral disposition index measured by oral glucose tolerance test

时间窗: 6 months

oral disposition index = insulinogenic index x 1/fasting insulin

次要结局

未报告次要终点

研究者

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

Nana Gletsu Miller

Associate Professor

Indiana University

研究点 (2)

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