跳至主要内容
临床试验/NCT02088086
NCT02088086已完成不适用

Randomized Controlled Trial of BMI Screening: Effects on Obesity, Disparities, and Body Satisfaction

University of California, Berkeley2 个研究点 分布在 1 个国家目标入组 36,452 人开始时间: 2014年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36,452
试验地点
2
主要终点
Change in body mass index (BMI) z-score

研究概览

简要总结

The Fit Study is a three-year, cluster-randomized controlled trial that will evaluate the impact of school-based body mass index (BMI) screening and reporting on child health. Seventy-nine California schools will be randomized to one of three groups: 1) BMI screening and reporting, 2) BMI screening, and 3) no BMI screening or reporting (control). Investigators will assess the impact of BMI reporting on students' BMI trajectories over three years. Investigators will also assess the impact of BMI screening on weight-based teasing, feelings of stigmatization, and weight-control behaviors among students.

详细描述

The Fit Study is a three-year, cluster-randomized controlled trial that will evaluate the impact of school-based body mass index (BMI) screening and reporting on childhood obesity and psychosocial outcomes. This study will take place during the 2014-15, 2015-16, and 2016-17 school years. Seventy-nine schools across California will be randomized to one of three groups: 1) BMI screening and reporting, 2) BMI screening, and 3) no BMI screening or reporting (control). Schools randomized to Groups 1 and 2 will conduct height and weight measurements annually with their 3rd-8th grade students. Group 1 and 2 schools will also administer the five fitness assessments (mile run or PACER test, curl-ups, push-ups, trunk lift, and sit and reach) annually with their 5th-8th grade students. In the fall of Years 2 and 3, Group 1 schools will mail a report home to parents with students' results from the previous spring. All 3rd and 4th grade parents will receive a report with BMI results only. Investigators will randomize the parents of 5th-8th grade students to receive a report that provides BMI results only or one that provides BMI results with results from the five fitness assessments. Schools randomized to Group 3 will not conduct height and weight measurements with their students during Years 1 and 2.

Each fall, investigators will administer a survey to 4th-8th grade students from all schools. This survey will assess weight-based teasing, feelings of stigmatization, and weight-control behaviors among students. The student survey will also ask questions about students' experiences having their heights and weights measured at school. During all years, investigators will mail a survey home a subsample of parents to assess parent behaviors related to their child's physical activity and nutrition, as well as parent reactions to the BMI report. Finally, schools will complete a survey in Spring 2017 to assess their nutrition- and physical activity-related policies and programs.

研究设计

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

入排标准

年龄范围
7 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria for school districts:
  • District does not report BMI results to caregivers and has no history of doing so
  • District has at least eight schools that meet all of the school-level eligibility criteria
  • Inclusion criteria for schools:
  • School does not report BMI results to caregivers and has no history of doing so
  • School has an enrollment of 15% to 85% Latino students
  • School has an enrollment of at least 30 students in grades 3 through 8
  • Inclusion criteria for students: Student is enrolled in 3rd-8th grade
  • Inclusion criteria for parents: Parent has a child who is enrolled in study
  • Inclusion criteria for teachers: Teacher measures the heights and weights of students for the study

排除标准

  • 未提供

研究组 & 干预措施

BMI screening only (Group 2)

Active Comparator

For three school years, 3rd-8th grade students will have their heights and weights measured once annually. Additionally, 5th-8th grade students will participate in five fitness assessments. Schools will NOT send BMI reports home to parents.

干预措施: BMI screening (Behavioral)

No BMI screening or reporting (Group 3)

No Intervention

For two school years, 3rd-8th grade students will NOT have their heights and weights measured at school.

BMI screening and reporting (Group 1)

Experimental

For three school years, 3rd-8th grade students will have their heights and weights measured once annually. Additionally, 5th-8th grade students will participate in five fitness assessments. Schools will send BMI reports home to parents.

干预措施: BMI screening (Behavioral)

BMI screening and reporting (Group 1)

Experimental

For three school years, 3rd-8th grade students will have their heights and weights measured once annually. Additionally, 5th-8th grade students will participate in five fitness assessments. Schools will send BMI reports home to parents.

干预措施: BMI reporting (Behavioral)

BMI screening and reporting (Group 1)

Experimental

For three school years, 3rd-8th grade students will have their heights and weights measured once annually. Additionally, 5th-8th grade students will participate in five fitness assessments. Schools will send BMI reports home to parents.

干预措施: Fitness testing (Behavioral)

BMI screening only (Group 2)

Active Comparator

For three school years, 3rd-8th grade students will have their heights and weights measured once annually. Additionally, 5th-8th grade students will participate in five fitness assessments. Schools will NOT send BMI reports home to parents.

干预措施: Fitness testing (Behavioral)

结局指标

主要结局

Change in body mass index (BMI) z-score

时间窗: Up to 2 years

Investigators will assess change in BMI z-score over 3 years between students in Group 1 (BMI screening + reporting) and students in Group 2 (BMI screening only). Primary analyses will be limited to students who were overweight (BMI ≥ 85th percentile) at baseline (Spring 2015). Investigators will also compare change in BMI z-score over 3 years between Group 1 students whose parents received the BMI-only report and Group 1 students whose parents received the BMI + fitness report. In both sets of analyses, ethnicity will be used as an effect modifier.

次要结局

  • Change in weight-control behaviors(Up to 2 years)
  • Change in weight-based teasing(Up to 2 years)
  • Change in body satisfaction(Up to 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验