A School-Based Nutrition and Fitness Program: Operation ToneUp
3 september 2026 uppdaterad 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
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
1400
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Arizona
-
Lake Havasu City, Arizona, Förenta staterna, 86403
- Lake Havasu Unified School District
-
Kontakt:
- Tony Lamka
- Telefonnummer: 602-432-2398
- E-post: tony@operationtoneup.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Inget ingripande: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Upper body strength
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Blood Pressure
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Allison Poulos, PhD, Arizona State University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 september 2026
Primärt slutförande (Beräknad)
1 maj 2027
Avslutad studie (Beräknad)
1 juli 2027
Studieregistreringsdatum
Först inskickad
31 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
31 augusti 2026
Första postat (Faktisk)
4 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 september 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STUDY00024777
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
The data sets associated with this study will be publicly available through the Arizona State University Library Research Data Repository.
Tidsram för IPD-delning
Beginning at the time of first publication
Kriterier för IPD Sharing Access
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-delning som stöder informationstyp
- STUDY_PROTOCOL
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .