ACTION PAC: Adolescents Committed to Improvement of Nutrition & Physical Activity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 991
- 试验地点
- 2
- 主要终点
- Change in Reported Added Sugar Intake
研究概览
简要总结
Using a previously created weight management program for adolescents, the intervention will be implemented through school-based health centers (SBHC) and will be delivered by SBHC providers trained in Motivational Interviewing. Students at intervention school sites will be compared to students at control school sites. All students will have baseline, 1 year, and 2 year follow-up to assess if students in the intervention school sites will have improved risk factor profile for metabolic syndrome, improved nutrition and increased physical activity when compared with students at control school sites.
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
- Single (Participant)
入排标准
- 年龄范围
- 13 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •enrolled in 9th or 10th grade at participating schools
排除标准
- •blood pressure in the range of stage 2 hypertension
- •previously diagnosed type 1 or type 2 diabetes
- •use of corticosteroids, antipsychotics, metformin, antihypertensive medications, and medications used for dyslipidemia
- •inability to perform moderate to vigorous physical activity
- •not ambulatory
- •a score of 20 or more on Eating Attitudes Test (EAT)-26 screening measure
- •developmental disorders that affect weight or ability to understand the study procedures or counseling
结局指标
主要结局
Change in Reported Added Sugar Intake
时间窗: Baseline to two years
Reported change in added sugar intake as measured by the Block Kids Food Screener-Last Week for Ages 2-17 for students who had a baseline BMI \<85th percentile and endline data
Change in Reported Fruit, Vegetables, and Legume Intake (Not Including Potatoes)
时间窗: Baseline to two years
Change in reported fruit, vegetables, and legume intake (not including potatoes) for students who had a baseline BMI \<85th percentile and endline data
Change in BMI Z-score
时间窗: Baseline to two years
Change in body-mass index (BMI; weight in kilograms divided by the square of the body height in meters) Z-score for students who had a baseline BMI \>= 85th percentile (overweight or obese) and endline data. A Z-score of 0 represents the population mean. A Z-score above 2 indicates obesity (BMI \>2 standard deviations above the mean) in children and teens. A decline in BMI Z-score would be a positive outcome in this weight management study.
Change in HOMA-IR
时间窗: Baseline to two years
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR; insulin resistance index) for students who had a baseline BMI \>= 85th percentile (overweight or obese) and endline data. HOMA-IR is calculated using the formula: (fasting glucose \[mg/dL\] x fasting insulin \[microU/mL\])/405. HOMA-IR values \>2 indicate insulin resistance. A decrease in HOMA-IR would be a positive outcome.
Number and Proportion of Participants With Baseline BMI <85th Percentile Who Developed Overweight or Obesity by the End of the Study
时间窗: Baseline to two years
Number and percentage of students who had a baseline BMI \<85th percentile who had a BMI\>= 85th percentile (overweight or obese) at endline
Change in Physical Activity
时间窗: Baseline to two years
Change in minutes of moderate-to-vigorous physical activity as measured by accelerometer for participants who had a baseline BMI \<85th percentile and endline data
次要结局
未报告次要终点
研究者
Alberta Kong, MD, MPH
Professor
University of New Mexico