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临床试验/NCT02039141
NCT02039141已完成不适用

Community-Based Diabetes Prevention Program for Obese Latino Youth: Every Little Step Counts

Arizona State University2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2012年4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
160
试验地点
2
主要终点
Change in Insulin Sensitivity / Glucose Tolerance, Measured at Baseline, Change 3-months, 6-months, and 12-months

研究概览

简要总结

The purpose of this study is to examine the effects of 12 week lifestyle intervention on diabetes risk in obese Latino adolescents.

详细描述

Obesity in the United States has reached epidemic proportions and Latinos youth are disproportionally impacted. Pediatric obesity is associated with several chronic health conditions including insulin resistance and type 2 diabetes. However, very few interventions specifically targeting diabetes prevention for obese Latino adolescents have been developed.

Therefore, the purpose of this study is to examine the effects a culturally-grounded, community-based lifestyle intervention on psychosocial and health outcomes among obese Latino adolescents. Eligible participants of this study will be randomly selected to the intervention group or the delayed-intervention group (control group) after an initial health screening for eligibility.

Participants selected to the intervention group will attend weekly healthy lifestyle education sessions with their parent(s)/guardian(s) and three physical activity sessions / week with other youth. After which, participants will attend monthly booster group meetings for three months.

All participants will be assessed at baseline, 3 months, 6 months, and 12 months for insulin sensitivity, glucose tolerance, quality of life, fitness, and nutrition and physical activity behaviors.

研究设计

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

入排标准

年龄范围
14 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Latino: self-report by parents
  • Age: 14-16
  • Obese: BMI percentile >= 95th percentile for age and gender or BMI >= 30 kg/m^2

排除标准

  • Taking medication(s) or diagnosed with a condition that could influence carbohydrate metabolism, physical activity, and/or cognition
  • Type 2 diabetes: Fasting plasma glucose >= 126 mg/dL or 2-hour plasma glucose >= 200 mg/dL (youth found to be diabetic through study's procedures will be referred for follow up care and excluded)
  • Recent hospitalizations (previous 2 months)
  • Currently enrolled in (or with in previous 6 months) a formal weight loss program
  • Diagnosed depression or other condition that may impact QoL

结局指标

主要结局

Change in Insulin Sensitivity / Glucose Tolerance, Measured at Baseline, Change 3-months, 6-months, and 12-months

时间窗: Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline

Proximal indicator of diabetes risk

Change in Quality of Life Measured at Baseline, 3-months, 6-months, and 12-months

时间窗: Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline

Generic and weight-specific quality of life

次要结局

  • Change in Self efficacy for healthy eating and exercise(Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline)
  • Change in Social support from family and friends on healthy eating and exercise.(Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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