- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02088086
BMI Screening and Reporting in Schools: The Fit Study
Randomized Controlled Trial of BMI Screening: Effects on Obesity, Disparities, and Body Satisfaction
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Berkeley, California, United States, 94720
- UC Berkeley School of Public Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
Exclusion Criteria: None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BMI screening and reporting (Group 1)
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.
|
Students in grades 3-8 will have their heights and weights measured annually at school and their BMIs calculated.
Schools will send a report home to parents that provides their child's height, weight, and BMI results.
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: BMI screening only (Group 2)
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.
|
Students in grades 3-8 will have their heights and weights measured annually at school and their BMIs calculated.
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: No BMI screening or reporting (Group 3)
For two school years, 3rd-8th grade students will NOT have their heights and weights measured at school.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in body mass index (BMI) z-score
Time Frame: 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.
|
Up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in weight-control behaviors
Time Frame: Up to 2 years
|
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
|
Change in weight-based teasing
Time Frame: Up to 2 years
|
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
|
Change in body satisfaction
Time Frame: Up to 2 years
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kristine A Madsen, MD MPH, University of California, Berkeley
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-07-4472
- R01HL120666 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Overweight
-
University Hospital, LilleNational Research Agency, France; European Union; University of Lille Nord de... and other collaboratorsNot yet recruitingOverweight and Obesity | Overweight, Childhood | Overweight, Infant
-
Children's Hospital Los AngelesUniversity of Southern California; Tufts Medical CenterRecruitingOverweight and Obesity | Overweight AdolescentsUnited States
-
University of AarhusThe Danish Dairy Research Foundation, Denmark; Sygekassernes HelsefondCompletedOverweight and Obesity | Overweight Adolescents | Metabolic DiseaseDenmark
-
Memorial Sloan Kettering Cancer CenterRecruitingObesity | Overweight | Overweight and Obesity | Obese | Overweight or ObesityUnited States
-
University Hospital Bispebjerg and FrederiksbergUniversity of CopenhagenCompleted
-
Holbaek SygehusUniversity of Copenhagen; University of Florida; University of Minnesota; Hebrew... and other collaboratorsRecruitingChildhood Overweight and ObesityDenmark
-
Khyber Medical University PeshawarRecruitingObesity, OverweightPakistan
-
Institut Investigacio Sanitaria Pere VirgiliCompletedObesity, Childhood | Overweight and Obesity | Overweight, ChildhoodSpain
-
National Taiwan University HospitalCompleted
-
Children's Hospital SrebrnjakBelupo; Podravka d.d.RecruitingBody Weight | Overweight and ObesityCroatia
Clinical Trials on BMI screening
-
Mansoura UniversityUnknown
-
The University of Texas Health Science Center,...Baylor College of Medicine; Duke University; Centers for Disease Control and... and other collaboratorsCompleted
-
University of MichiganNational Institute on Drug Abuse (NIDA)Completed
-
HealthPartners InstituteNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Enrolling by invitation
-
University of Texas Southwestern Medical CenterNational Heart, Lung, and Blood Institute (NHLBI)CompletedOverweight | Childhood ObesityUnited States
-
University of MinnesotaCompleted
-
Nationwide Children's HospitalCompleted
-
University of RochesterNational Institute on Drug Abuse (NIDA)Completed
-
University of PittsburghCompletedBipolar Disorder | Medication AdherenceUnited States
-
University of Split, School of MedicineClinical Hospital Centre ZagrebUnknownApnea | Obesity | Respiratory Insufficiency | Sedation Complication | Hypoxic Respiratory Failure | Airway Obstruction, NasalCroatia