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A School-Based Nutrition and Fitness Program: Operation ToneUp

A School-Based Nutrition and Fitness Program: Operation ToneUp

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07803666
Enrollment
1400
Registered
2026-09-04
Start date
2026-09-01
Completion date
2027-07-01
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, Exercise, Nutrition Knowledge

Keywords

Exercise, Food, Blood pressure

Brief summary

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: 1. Do students participating in the intervention show improved fitness, measured by upper body strength, core strength, and cardiovascular endurance? 2. Do students participating in the intervention show improved nutrition knowledge, measured by self-report? 3. 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

Interventions

BEHAVIORALNutrition and fitness intervention

School-based nutrition and fitness program using interactive web platform twice weekly for 20 minutes each session delivered in classroom settings.

Sponsors

Arizona State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
9 Years to 14 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Upper body strengthFrom enrollment to end of 8-week interventionNumber of push-ups completed with set form according to the Fitnessgram protocol to a set cadence * Correct form includes hands under shoulders, legs straight with toes tucked under, feet no wider than shoulder width apart, arms bend down to 90 degrees with back straight once every 3 seconds * Test ends after second form break * Range of scores includes 0 to 75 maximum
Core strengthFrom enrollment to end of 8-week interventionNumber 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
Cardiovascular enduranceFrom enrollment to end of 8-week interventionNumber 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.

Secondary

MeasureTime frameDescription
Nutrition knowledgeFrom enrollment to end of 8-week interventionNumber 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.
Blood PressureFrom enrollment to the end of 8-week interventionBlood pressure numbers assessed by school nurses using a manual pediatric cuff

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAllison Poulos, PhD

Arizona State University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026