Clinical trial NCT02088086: BMI Screening and Reporting in Schools: The Fit Study
Official title: Randomized Controlled Trial of BMI Screening: Effects on Obesity, Disparities, and Body Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Overweight
Keywords: Pediatric obesity
Overweight
Body mass index
Primary schools
Secondary schools
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-03-14
Enrollment: 36452
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in body mass index (BMI) z-score
timeFrame: Up to 2 years
Secondary outcomes:
measure: Change in weight-control behaviors
timeFrame: Up to 2 years
measure: Change in weight-based teasing
timeFrame: Up to 2 years
measure: Change in body satisfaction
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: UC Berkeley School of Public Health
state: California
Study officials:
affiliation: University of California, Berkeley
name: Kristine A Madsen, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Madsen KA, Thompson HR, Linchey J, Ritchie LD, Gupta S, Neumark-Sztainer D, Crawford PB, McCulloch CE, Ibarra-Castro A. Effect of School-Based Body Mass Index Reporting in California Public Schools: A Randomized Clinical Trial. JAMA Pediatr. 2021 Mar 1;175(3):251-259. doi: 10.1001/jamapediatrics.2020.4768.
citation: Thompson HR, Linchey JK, Liu NF, Madsen KA. Parents Recall of, and Reactions to, School-Based BMI Reports. Child Obes. 2019 Dec;15(8):548-554. doi: 10.1089/chi.2019.0061. Epub 2019 Aug 12.
citation: Thompson HR, Linchey JK, King B, Himes JH, Madsen KA. Accuracy of School Staff-Measured Height and Weight Used for Body Mass Index Screening and Reporting. J Sch Health. 2019 Aug;89(8):629-635. doi: 10.1111/josh.12788. Epub 2019 May 28.
citation: Madsen KA, Linchey J, Ritchie L, Thompson HR. The Fit Study: Design and rationale for a cluster randomized trial of school-based BMI screening and reporting. Contemp Clin Trials. 2017 Jul;58:40-46. doi: 10.1016/j.cct.2017.05.005. Epub 2017 May 4.