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BMI Screening and Reporting in Schools: The Fit Study

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ClinicalTrials.gov Identifier: NCT02088086
Recruitment Status : Completed
First Posted : March 14, 2014
Last Update Posted : August 28, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of California, Berkeley

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pediatric Obesity Overweight Behavioral: BMI screening Behavioral: BMI reporting Behavioral: Fitness testing Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36452 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of BMI Screening: Effects on Obesity, Disparities, and Body Satisfaction
Study Start Date : March 2014
Actual Primary Completion Date : June 15, 2017
Actual Study Completion Date : July 15, 2017
Arms and Interventions
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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.
 Behavioral: BMI screening
Students in grades 3-8 will have their heights and weights measured annually at school and their BMIs calculated.

Behavioral: BMI reporting
Schools will send a report home to parents that provides their child's height, weight, and BMI results.

Behavioral: 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: 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.
 Behavioral: BMI screening
Students in grades 3-8 will have their heights and weights measured annually at school and their BMIs calculated.

Behavioral: 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: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088086


Locations
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United States, California
UC Berkeley School of Public Health
Berkeley, California, United States, 94720
Sponsors and Collaborators
University of California, Berkeley
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Kristine A Madsen, MD MPH University of California, Berkeley
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of California, Berkeley
ClinicalTrials.gov Identifier: NCT02088086    
Other Study ID Numbers: 2012-07-4472
R01HL120666 ( U.S. NIH Grant/Contract )
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017
Keywords provided by University of California, Berkeley:
Pediatric obesity
Overweight
Body mass index
Primary schools
Secondary schools
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overweight
 Overnutrition
Nutrition Disorders
Body Weight