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Randomized Controlled Trial
. 2017 Jul:58:40-46.
doi: 10.1016/j.cct.2017.05.005. Epub 2017 May 4.

The Fit Study: Design and rationale for a cluster randomized trial of school-based BMI screening and reporting

Affiliations
Randomized Controlled Trial

The Fit Study: Design and rationale for a cluster randomized trial of school-based BMI screening and reporting

Kristine A Madsen et al. Contemp Clin Trials. 2017 Jul.

Abstract

Background: In the U.S., 25 states conduct body mass index (BMI) screening in schools, just under half of which report results to parents. While some experts recommend the practice, evidence demonstrating its efficacy to reduce obesity is lacking, and concerns about weight-related stigma have been raised.

Methods/design: The Fit Study is a 3-arm cluster-randomized trial assessing the effectiveness of school-based BMI screening and reporting in reducing pediatric obesity and identifying unintended consequences. Seventy-nine elementary and middle schools across California were randomized to 1 of 3 Arms: 1) BMI screening and reporting; 2) BMI screening only; or 3) no BMI screening or reporting. In Arm 1 schools, students were further randomized to receive reports with BMI results alone or both BMI and fitness test results. Over 3 consecutive years, staff in schools in Arms 1 and 2 will measure students' BMI (grades 3-8) and additional aspects of fitness (grades 5-8), and students in grades 4-8 in all Arms will complete surveys to assess weight-based stigmatization. Change in BMI z-score will be compared between Arm 1 and Arm 2 to determine the impact of BMI reporting on weight status, with sub-analyses stratified by report type (BMI results alone versus BMI plus fitness results) and by race/ethnicity. The potential for BMI reports to lead to weight-based stigma will be assessed by comparing student survey results among the 3 study Arms.

Discussion: This study will provide evidence on both the benefit and potential unintended harms of school-based BMI screening and reporting.

Trial registration: ClinicalTrials.gov NCT02088086.

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Figures

Figure 1
Figure 1. Screening and randomization
a Excludes 60 districts that had no students in 3rd–8th grade (e.g., high schools) b School-level eligibility criteria: ≥30 students per grade and ≥15% and ≤85% Latino students c In 1 school district with 13 participating schools, a subset of classrooms in 9 schools engaged in a local clinical BMI screening and referral program and participating students (n=275) were excluded
Figure 2
Figure 2. Longitudinal survey and BMI data collection
Diagonal boxes indicate students being followed over time. Solid boxes - students in K-5, 6–8, and 7–8 schools; dashed boxes - additional assessments in K-6 and K-8 schools. Grade 3 students will not complete surveys. For students in Study Arm 3 (control), students will have BMI assessed in the 2016–17 school year only.

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