BMI Screening and Reporting in Schools: The Fit Study

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02088086
• Other study ID #: 2012-07-4472
• Secondary ID: R01HL120666
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: July 15, 2017

Study information

• Verified date: November 2021
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36452
• Est. completion date: July 15, 2017
• Est. primary completion date: June 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

Inclusion Criteria:

Inclusion criteria for school districts:

1. District does not report BMI results to caregivers and has no history of doing so

2. District has at least eight schools that meet all of the school-level eligibility criteria

Inclusion criteria for schools:

1. School does not report BMI results to caregivers and has no history of doing so

2. School has an enrollment of 15% to 85% Latino students

3. 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

Exclusion Criteria: None

Related Conditions & MeSH terms

• Obesity
• Overweight
• Pediatric Obesity

Intervention

Behavioral:
• BMI screening
Students in grades 3-8 will have their heights and weights measured annually at school and their BMIs calculated.
• BMI reporting
Schools will send a report home to parents that provides their child's height, weight, and BMI results.
• Fitness testing
Students in grades 5-8 will participate in five fitness assessments (curl-ups, sit-ups, push-ups, sit-and-reach, and the PACER test or mile run) annually at school.

Locations

Country	Name	City	State
United States	UC Berkeley School of Public Health	Berkeley	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Berkeley	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body mass index (BMI) z-score	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.	Up to 2 years
Secondary	Change in weight-control behaviors	Investigators will compare change in weight-control behaviors (assessed via a survey) between students in Group 3, who did not have their heights and weights measured for 2 school years, and students in Groups 1 and 2, who had their heights and weights measured during those years.	Up to 2 years
Secondary	Change in weight-based teasing	Investigators will compare change in experiences of weight-based teasing (assessed via a survey) between students in Group 3, who did not have their heights and weights measured for 2 school years, and students in Groups 1 and 2, who had their heights and weights measured during those years.	Up to 2 years
Secondary	Change in body satisfaction	Investigators will compare change in body satisfaction (assessed via a survey) between students in Group 3, who did not have their heights and weights measured for 2 school years, and students in Groups 1 and 2, who had their heights and weights measured during those years.	Up to 2 years