A School-Based Nutrition and Fitness Program: Operation ToneUp
3. september 2026 oppdatert av: Arizona State University
The goal of this clinical trial is to learn if a school-based intervention, Operation ToneUp, can improve nutrition knowledge, fitness, and blood pressure in schoolchildren enrolled in grades 3-6. The main questions it aims to answer are:
- Do students participating in the intervention show improved fitness, measured by upper body strength, core strength, and cardiovascular endurance?
- Do students participating in the intervention show improved nutrition knowledge, measured by self-report?
- Do students participating in the intervention show improved blood pressure, measured by blood pressure cuff?
Researchers will compare students participating in the intervention to students at comparison schools to see if fitness, nutrition knowledge, and blood pressure differ.
Participants in the intervention arm will complete two 20-minute web-based sessions focused on nutrition and fitness during class time. Participants in the comparison arm will not be exposed to Operation ToneUp. All participants will engage in pre- and post- testing including:
- PE-teacher assessed push-ups, curl-ups, and PACER test
- online self-reported nutrition knowledge assessments
- nurse-recorded blood pressure
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
1400
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Arizona
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Lake Havasu City, Arizona, Forente stater, 86403
- Lake Havasu Unified School District
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Ta kontakt med:
- Tony Lamka
- Telefonnummer: 602-432-2398
- E-post: tony@operationtoneup.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Intervention schools 1) serve students in grades 3-6; 2) intend to implement Operation Tone-Up 3 days/week over 8 weeks; and 3) are not participating in other fitness related research
- Non-intervention schools 1) 1) serve students in grades 3-6 and 2) are not participating in other fitness related research
- Children/students are 1) boys or girls enrolled in 3rd-6th grade at participating schools, 2) without parent/caregiver opt-out
Exclusion Criteria:
- Schools do not serve students in grades 3-6 will be excluded from the study
- Students not enrolled in grades 3 through 6 or have parent/caregiver opt-out
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Operation ToneUp Arm
Students in the intervention arm will complete two 20-minute web-based activities designed to promote nutrition knowledge and fitness in the classroom over eight weeks.
|
School-based nutrition and fitness program using interactive web platform twice weekly for 20 minutes each session delivered in classroom settings.
|
|
Ingen inngripen: Comparison Arm
Students in the comparison arm will not be exposed to the Operation ToneUp intervention and will continue with typical classroom sessions during school.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Upper body strength
Tidsramme: From enrollment to end of 8-week intervention
|
Number of push-ups completed with set form according to the Fitnessgram protocol to a set cadence
|
From enrollment to end of 8-week intervention
|
|
Core strength
Tidsramme: From enrollment to end of 8-week intervention
|
Number of curl-ups completed with set form according to the Fitnessgram protocol to a set cadence - Correct form includes knees bent and feet flat, palms flat and fingertips straight; fingertips slide over a 4.5 inch piece of fabric while curling up with heels in contact with floor and head touching back to mat on return once every 3 seconds - Test ends after second form break - Range of scores includes 0 to 75 maximum
|
From enrollment to end of 8-week intervention
|
|
Cardiovascular endurance
Tidsramme: From enrollment to end of 8-week intervention
|
Number of laps completed to a set cadence without breaking form; Correct form - run from one line to another 20 meters away before the beep; Beep is played with standard Fitnessgram audio and gets progressively faster with time; Test ends when a runner can no longer keep up with beeps and score is recorded; Range of scores is 0 to 247 over a possible span of 22 minutes.
|
From enrollment to end of 8-week intervention
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Blood Pressure
Tidsramme: From enrollment to the end of 8-week intervention
|
Blood pressure numbers assessed by school nurses using a manual pediatric cuff
|
From enrollment to the end of 8-week intervention
|
|
Nutrition knowledge
Tidsramme: From enrollment to end of 8-week intervention
|
Number of correct items on a 10-item multiple choice assessment of nutrition knowledge.
The assessment was not derived from an existing scale.
Scores are calculated based on the sum of the number of correct responses to each item.
Each item has only one correct response.
|
From enrollment to end of 8-week intervention
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Allison Poulos, PhD, Arizona State University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. mai 2027
Studiet fullført (Antatt)
1. juli 2027
Datoer for studieregistrering
Først innsendt
31. august 2026
Først innsendt som oppfylte QC-kriteriene
31. august 2026
Først lagt ut (Faktiske)
4. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. september 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY00024777
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
The data sets associated with this study will be publicly available through the Arizona State University Library Research Data Repository.
IPD-delingstidsramme
Beginning at the time of first publication
Tilgangskriterier for IPD-deling
All individuals will have access to the IPD in the repository.
This information will include the study protocol and de-identified individual data.
Data will be accessible via web link included in all associated publications.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .