Overview

This trial is active, not recruiting.

Conditions pediatric obesity, overweight
Treatments bmi screening, bmi reporting, fitness testing
Sponsor University of California, Berkeley
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date March 2014
End date June 2017
Trial size 38830 participants
Trial identifier NCT02088086, 2012-07-4472, R01HL120666

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-five 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(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.
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.
(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.
bmi screening
Students in grades 3-8 will have their heights and weights measured annually at school and their BMIs calculated.
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.
(No Intervention)
For two school years, 3rd-8th grade students will NOT have their heights and weights measured at school.

Primary Outcomes

Measure
Change in body mass index (BMI) z-score
time frame: Up to 2 years

Secondary Outcomes

Measure
Change in weight-control behaviors
time frame: Up to 2 years
Change in weight-based teasing
time frame: Up to 2 years
Change in body satisfaction
time frame: Up to 2 years

Eligibility Criteria

Male or female participants at least 7 years old.

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

Additional Information

Official title Randomized Controlled Trial of BMI Screening: Effects on Obesity, Disparities, and Body Satisfaction
Principal investigator Kristine A Madsen, MD MPH
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-five 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. In Years 1 and 2, 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by University of California, Berkeley.