Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Middle-School Based Primary Prevention Trial (HEALTHY)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,603
- 试验地点
- 16
- 主要终点
- Fasting glucose (mg/dL)
研究概览
简要总结
HEALTHY was a primary prevention trial conducted in 42 middle schools at 7 locations across the US to impact risk factors for type 2 diabetes in adolescents. Students were recruited at start of 6th grade (fall 2006) and followed to end of 8th grade (spring 2009). Half of the schools were randomized to receive an intervention that integrated four components: the school nutrition environment, physical education class activities, behavior change initiatives, and educational and promotional communications activities.
详细描述
In response to increases in incident cases of type 2 diabetes in American children and youth, NIDDK funded a multi-site primary prevention trial designed to moderate risk for type 2 diabetes in middle school aged children. In pilot studies, it was found that an indicator of adiposity, a body mass index greater than the 85th percentile for gender and age, was the most prevalent, modifiable risk factor for diabetes in this age group. In addition, indicators of insulin resistance and dysglycemia, elevated mean fasting insulin and glucose levels, were assessed to determine if the intervention was capable of reducing these risk factors for diabetes in middle school aged children.
The trial was conducted at 7 field centers in 42 middle schools randomly assigned to intervention or control. Following student recruitment and baseline data collection in the first semester of 6th grade (2006), the intervention was implemented in the second semester of 6th grade (2007) and continued throughout 7th (school year 2007-2008) and 8th (school year 2008-2009) grades. All students were exposed to components of the intervention, which were implemented school-wide or grade-wide; however, only students who provided appropriate informed consent and assent participated in data collection and evaluation. The primary objective of the trial was to determine if, at the end of the 8th grade, the intervention significantly impacted the risk for developing type 2 diabetes compared to control.
Six pilot studies were performed to collect data to guide the development of an intervention. The prior studies focused on:
- Establishing the feasibility of recruiting students and obtaining physical and physiological measurements, including fasting and 2-hour post glucose load blood draws (early 2003).
- Evaluating a physical education (PE) class program designed to increase moderate-to-vigorous physical activity (late 2003).
- Testing the ability of a nutrition intervention to change food and beverage offerings in school food service and vending (early 2004).
- Implementing a program that integrated the PE class and food service nutrition interventions with a communications and awareness campaign (fall 2004).
- Determining the feasibility of a behavior change intervention, delivered through in-class and other school settings and family outreach, to accomplish self monitoring and goal setting (fall 2005).
- Evaluating PE class activities targeting 7th and 8th graders and a training and support program to motivate PE teacher buy-in and adherence (fall 2005).
Formative research was conducted to inform the creation of all intervention components.
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
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Middle school student body is at least 50% minority (defined as African American, Hispanic/Latino, and/or Native American) and/or greater than 50% eligible for free or reduced lunch.
- •Middle school annual school-wide attrition from all causes is <= 25% (estimate determined from data provided by the school).
- •Middle school expected cohort size at end of study is at least 50 per school determined by applying 50% anticipated enrollment rate and annual school-wide attrition rate over 3 years.
- •Student able to participate in the school's standard PE program.
- •Student's parent/guardian has provided informed consent for the child to participate in data collection and evaluation procedures.
- •Student has provided informed assent to participate in data collection and evaluation procedures.
排除标准
- •(none specified)
结局指标
主要结局
Fasting glucose (mg/dL)
时间窗: baseline, end of study
Body mass index (BMI) >= 85th percentile, adjusted for gender and age
时间窗: baseline, end of 7th grade, end of study
Fasting insulin (mU/mL)
时间窗: baseline, end of study
次要结局
- Grade and school level comportment rates (i.e., referral to administrative offices for disciplinary action)(end of 6th, 7th, 8th grades)
- Blood pressure(baseline, end of study)
- Total school food environment amounts and nutrients(baseline, end of 7th grade, end of study)
- Waist circumference(baseline, end of study)
- Physical activity(baseline, end of study)
- Sedentary behavior(baseline, end of study)
- Daily nutritional intake(baseline, end of study)
- Grade and school level state standardized test score pass rates(end of 6th, 7th, 8th grades)
- Other laboratory indicators of diabetes and obesity risk, such as HbA1c(baseline, end of study)
- Quality-adjusted life years saved (QALYS)(baseline, end of 7th grade, end of study)
- Grade and school level attendance rates(end of 6th, 7th, 8th grades)
- Lipids (total cholesterol, HDL, LDL, triglycerides)(baseline, end of study)
- Fitness(baseline, end of study)
- PE class activity level (MVPA by heart rate monitor)(baseline, end of 7th grade, end of study)
- Costs associated with intervention delivery and administration(once per intervention semester (5 x))
- Decisions, policies, and activities at the school, local, state, or federal level that influence the school environment for nutrition and physical activity(once per year (3 x))