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BMI Screening and Reporting in Schools: The Fit Study

Primary Purpose

Pediatric Obesity, Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BMI screening
BMI reporting
Fitness testing
Sponsored by
University of California, Berkeley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obesity focused on measuring Pediatric obesity, Overweight, Body mass index, Primary schools, Secondary schools

Eligibility Criteria

7 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UC Berkeley School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

BMI screening and reporting (Group 1)

BMI screening only (Group 2)

No BMI screening or reporting (Group 3)

Arm Description

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.

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.

For two school years, 3rd-8th grade students will NOT have their heights and weights measured at school.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
March 7, 2014
Last Updated
November 2, 2021
Sponsor
University of California, Berkeley
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT02088086
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
June 15, 2017 (Actual)
Study Completion Date
July 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Berkeley
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity, Overweight
Keywords
Pediatric obesity, Overweight, Body mass index, Primary schools, Secondary schools

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36452 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMI screening and reporting (Group 1)
Arm Type
Experimental
Arm Description
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.
Arm Title
BMI screening only (Group 2)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No BMI screening or reporting (Group 3)
Arm Type
No Intervention
Arm Description
For two school years, 3rd-8th grade students will NOT have their heights and weights measured at school.
Intervention Type
Behavioral
Intervention Name(s)
BMI screening
Intervention Description
Students in grades 3-8 will have their heights and weights measured annually at school and their BMIs calculated.
Intervention Type
Behavioral
Intervention Name(s)
BMI reporting
Intervention Description
Schools will send a report home to parents that provides their child's height, weight, and BMI results.
Intervention Type
Behavioral
Intervention Name(s)
Fitness testing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in body mass index (BMI) z-score
Description
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.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Change in weight-control behaviors
Description
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.
Time Frame
Up to 2 years
Title
Change in weight-based teasing
Description
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.
Time Frame
Up to 2 years
Title
Change in body satisfaction
Description
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.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristine A Madsen, MD MPH
Organizational Affiliation
University of California, Berkeley
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Berkeley School of Public Health
City
Berkeley
State/Province
California
ZIP/Postal Code
94720
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33196797
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.
Results Reference
derived
PubMed Identifier
31403338
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.
Results Reference
derived
PubMed Identifier
31140199
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.
Results Reference
derived
PubMed Identifier
28479218
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.
Results Reference
derived

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BMI Screening and Reporting in Schools: The Fit Study

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