Type 2 Diabetes Primary Prevention for At Risk Girls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Change in Body Mass Index (BMI)
研究概览
简要总结
Purpose: To evaluate two approaches to prevent obesity and type 2 diabetes in young girls.
The Need: We are experiencing an epidemic of childhood obesity. Rates of obesity have doubled to tripled in the past two decades, with the highest rates among poor and ethnic minority girls. Type 2 diabetes (what used to be called adult-onset diabetes) is now showing up in overweight children, and more children are manifesting precursors of heart disease and stroke.
Our Two Approaches:
- A state-of-the-art nutrition education program with monthly newsletters mailed to girls and their parents and quarterly evening lectures/educational events at school sites, including cooking demonstrations and games to improve nutrition and increase physical activity.
- After-school dance classes held five days per week all year long at school sites from the time school lets out until 6PM. Dance classes will include a 1-1.5 hour supervised homework study hall each day, and emphasize both traditional ethnic dances and popular dance.
Participants: Second, third and fourth grade girls and their families will be eligible to participate. All activities are free of charge. To be able to perform a valid evaluation, to be able to accommodate all girls at their own school, and to be fair about which girls receive which program, families who wish to participate will be randomly selected to participate in either one program or the other (nutrition education or dance classes). Each family will participate for two years.
Evaluation: Trained Stanford staff will perform all evaluation procedures with participating families in their own homes at the beginning and every six months. Families will be compensated for their participation.
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
- 7 Years 至 10 Years(Child)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Second-, third- and fourth-grade girls, aged 7-10 years of age enrolled in one of the participating schools will be eligible. Our goal is to be as inclusive as possible. However, girls will not be eligible to participate if they:
- •have been diagnosed with a chronic illness that affects their growth and/or weight (e.g., type 1 diabetes, hypothyroidism, inflammatory bowel disease)
- •are taking medications potentially affecting their growth and/or weight (e.g., methylphenidate HCl, systemic steroids)
- •have Asthma (not exclusionary alone) but have taken systemic steroids (oral, intravenous, or intramuscular) for a period of more than 21 days in the past year
- •have a condition that limits their participation in physical activity enough that they are not able to participate in Physical Education at school (e.g., significant structural heart disease)
- •are pregnant
- •are unable to complete the informed consent process.
排除标准
- 未提供
研究组 & 干预措施
Nutrition Education
A state-of-the-art nutrition education program with monthly newsletters mailed to girls and their parents and quarterly evening lectures/educational events at school sites, including cooking demonstrations and games to improve nutrition and increase physical activity.
干预措施: Nutrition Education (Behavioral)
After-school dance class
After-school dance classes held five days per week all year long at school sites from the time school lets out until 6PM. Dance classes will include a 1-1.5 hour supervised homework study hall each day, and emphasize both traditional ethnic dances and popular dance.
干预措施: After-school dance class (Behavioral)
结局指标
主要结局
Change in Body Mass Index (BMI)
时间窗: 24 months
Change in body mass index (BMI) over the 2-year intervention period. BMI was calculated as weight in kilograms divided by height in meters squared.
次要结局
- Change in Waist Circumference(24 months)
- Change in Total Cholesterol(24 months)
- Change in LDL Cholesterol Level(24 months)
- Change in HDL Cholesterol Level(24 months)
- Change in Fasting Glucose(24 months)
- Change in Fasting Insulin(24 months)
