Pediatric ObesityNCT02088086
BMI Screening and Reporting in Schools: The Fit Study
A study testing BMI screening, BMI reporting and Fitness testing in people with Pediatric Obesity and Overweight, run by University of California, Berkeley at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Pediatric Obesity, Overweight
- What is being tested?
- BMI screening, BMI reporting and Fitness testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36,452 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 15 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Berkeley School of Public Health
Berkeley, California, 94720
About this study
Official title: Randomized Controlled Trial of BMI Screening: Effects on Obesity, Disparities, and Body Satisfaction
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.
Read the 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.
- Conditions
- Pediatric Obesity, Overweight
- Being tested
- BMI screening, BMI reporting, Fitness testing
- Keywords
- Pediatric obesity, Overweight, Body mass index, Primary schools, Secondary schools
- Medical subject headings
- Pediatric Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMI screeningBehavioural
Students in grades 3-8 will have their heights and weights measured annually at school and their BMIs calculated.
BMI reportingBehavioural
Schools will send a report home to parents that provides their child's height, weight, and BMI results.
Fitness testingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: BMI screening; Behavioral: BMI reporting; Behavioral: 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. Receives: Behavioral: BMI screening; Behavioral: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Secondary outcomes (3)
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.
Measured: Up to 2 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.
Measured: Up to 2 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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startMar 2014
- Primary completion15 Jun 2017
- Study completion15 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36,452 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Kristine A Madsen, MD MPH, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088086
- Sponsor's protocol ID
- 2012-07-4472
- Other IDs
- R01HL120666
- Status last verified
- Nov 2021
- First submitted
- 7 Mar 2014
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 33196797Thompson 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.
PubMed 31403338Thompson 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.
PubMed 31140199Madsen 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.
PubMed 28479218
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of BMI Screening: Effects on Obesity, Disparities, and Body Satisfaction
- ClinicalTrials.gov ID
- NCT02088086
- Acronym / sponsor ID
- 2012-07-4472
- Conditions
- Pediatric Obesity, Overweight
- Keywords
- Pediatric obesity, Overweight, Body mass index, Primary schools, Secondary schools
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36,452 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2014
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 15 Jul 2017 (actual)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BMI screening and reporting (Group 1) | Experimental | Behavioral: BMI screening, Behavioral: BMI reporting, Behavioral: Fitness testingFor 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. |
| BMI screening only (Group 2) | Active comparator | Behavioral: BMI screening, Behavioral: Fitness testingFor 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. |
| 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. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMI screeningStudents in grades 3-8 will have their heights and weights measured annually at school and their BMIs calculated. | Behavioural | BMI screening and reporting (Group 1), BMI screening only (Group 2) |
| BMI reportingSchools will send a report home to parents that provides their child's height, weight, and BMI results. | Behavioural | BMI screening and reporting (Group 1) |
| Fitness testingStudents 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. | Behavioural | BMI screening and reporting (Group 1), BMI screening only (Group 2) |
Primary outcome
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.
3 secondary outcomes
Change in weight-control behaviors
Time frame: Up to 2 years
Change in weight-based teasing
Time frame: Up to 2 years
Change in body satisfaction
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Derived from this study: PubMed 33196797Madsen 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.
- Derived from this study: PubMed 31403338Thompson 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.
- Derived from this study: PubMed 31140199Thompson 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.
- Derived from this study: PubMed 28479218Madsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristine A Madsen, MD MPH principal investigator
University of California, Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BMI screening, BMI reporting and Fitness testing in people with Pediatric Obesity and Overweight, run by University of California, Berkeley at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body mass index (BMI) z-score (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02088086, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.