NCT02088086

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36,452

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2017

Completed
Last Updated

November 4, 2021

Status Verified

November 1, 2021

Enrollment Period

3.3 years

First QC Date

March 7, 2014

Last Update Submit

November 2, 2021

Conditions

Keywords

Pediatric obesityOverweightBody mass indexPrimary schoolsSecondary schools

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 2 years

Secondary Outcomes (3)

  • Change in weight-control behaviors

    Up to 2 years

  • Change in weight-based teasing

    Up to 2 years

  • Change in body satisfaction

    Up to 2 years

Study Arms (3)

BMI screening and reporting (Group 1)

EXPERIMENTAL

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 screeningBehavioral: BMI reportingBehavioral: Fitness testing

BMI screening only (Group 2)

ACTIVE COMPARATOR

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 screeningBehavioral: Fitness testing

No BMI screening or reporting (Group 3)

NO INTERVENTION

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

Interventions

BMI screeningBEHAVIORAL

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

BMI screening and reporting (Group 1)BMI screening only (Group 2)
BMI reportingBEHAVIORAL

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

BMI screening and reporting (Group 1)
Fitness testingBEHAVIORAL

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.

BMI screening and reporting (Group 1)BMI screening only (Group 2)

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Berkeley School of Public Health

Berkeley, California, 94720, United States

Location

Related Publications (4)

  • 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.

MeSH Terms

Conditions

Pediatric ObesityOverweight

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

ObesityOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Kristine A Madsen, MD MPH

    University of California, Berkeley

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2014

First Posted

March 14, 2014

Study Start

March 1, 2014

Primary Completion

June 15, 2017

Study Completion

July 15, 2017

Last Updated

November 4, 2021

Record last verified: 2021-11

Locations