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临床试验/NCT02291146
NCT02291146已完成不适用

LA Sprouts: The Impact of Gardening and Nutrition Education on Childhood Obesity in Latino Youth

University of Southern California2 个研究点 分布在 1 个国家目标入组 421 人开始时间: 2011年7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
421
试验地点
2
主要终点
change in blood pressure

研究概览

简要总结

The overall goal of this project is to conduct a randomized controlled 12-week after school, gardening, nutrition and cooking program (called "LA Sprouts") to improve dietary intake and reduce obesity in 3rd, 4th and 5th grade students (ages 8-12 years) in Los Angeles. Approximately 400 3rd - 5th grade students participating in the LA's Best after school program will participate. Four elementary schools in Los Angeles will be selected to participate in the study. Schools will be randomized by region to either receive the intervention (LA Sprouts; 2 schools, n=200 students) or serve as controls (received a delayed intervention program one school semester later; 2 schools, n=200 students). The LA Sprouts intervention will take place at the elementary schools, with gardens on campus specially designed and built for this project. The program will be held once a week for 12 weeks and will consist of a 45-minute gardening lesson, taught by Master Gardeners from the University of California Cooperative Extension (supervised by Nicole Gatto, MPH, PhD), and a 45-minute nutrition education and cooking lesson, taught by USC a Nutrition Educator (supervised by Jaimie Davis, PhD, RD). Measures of childhood obesity (i.e., body mass index (BMI) and body fat percentages), blood pressure, metabolic function (fasting blood glucose, insulin and lipids), dietary intake and related behaviors, and school performance will be measured before and after the implementation of the program in both intervention and control participants. Approximately 10 additional students of the same age will be asked to participate in a focus group to evaluate the questionnaire developed for this study. In addition, approximately 20 additonal students of the same age will be asked to participate in a test-retest session to validate the reliability of the questionnaire.

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
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Normal, Overweight and Obese Children: Investigators will attempt to obtain a natural selection of normal weight children (age- & sex-specific BMI < 85th percentile based on CDC BMI growth charts (40) and overweight and obese children (BMI ≥ 85th percentile). Based on preliminary data from these areas, investigators expect that at least 50% of the sample will be overweight or obese. There will not be an upper BMI limit.
  • Gender & Age: Investigators will attempt to enroll equal numbers of female and male students in 3rd through 5th grades (8-12 years of age).
  • Latino origin: This study will include all ethnicities, however the selected schools are >90% Latino.

排除标准

  • The following criteria are exclusionary: presently taking medication(s) or diagnosed with any disease that could influence dietary intake or body composition; previously diagnosed with any major illness since birth (e.g. chronic birth asphyxia, cancer, etc.); any physical, cognitive, or psychological disability that would prevent participation in the study. Participants testing positive for diabetes (as determined from the fasting blood draw) will be referred for treatment. (Note: subjects with pre-diabetes will be eligible for the study). Although participant data may be excluded based on the above exclusion criteria, participation in the program classes may be allowed. Individual cases will be reviewed as they arise.

结局指标

主要结局

change in blood pressure

时间窗: baseline and 12 weeks

change in adiposity

时间窗: baseline and 12 weeks

measured by BMI, waist circumference, and body fat percentages (via Tanita scale)

change in metabolic function

时间窗: baseline and 12 weeks

measured by fasting glucose, insulin and lipids

次要结局

  • change in dietary intake(basline and 12 weeks)
  • change in determinants of fruit and vegetable intake(basline and 12 weeks)

研究者

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

Donna Spruijt-Metz

Principal Investigator

University of Southern California

研究点 (2)

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