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NCT Number: NCT07803666

A School-Based Nutrition and Fitness Program: Operation ToneUp

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

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Key information

Conditions

Exercise Behavior Blood Pressure Motor Activity Nutrition Knowledge

Age range

9 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lake Havasu Unified School District

Lake Havasu City, Arizona, 86403, United States

Location contact

Tony Lamka

CONTACT

[email protected]

602-432-2398

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Intervention schools: Must 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 school: Must 1) 1) serve students in grades 3-6 and 2) are not participating in other fitness related research.

Children/students: Include 1) boys and girls enrolled in 3rd-6th grade at participating schools, 2) without parent/caregiver opt-out.

Exclusion criteria

Schools that do not serve students in grades 3-6 will be excluded from the study.

Students will be excluded if they are not enrolled in grades 3 through 6 or have parent/caregiver opt-out.

Treatment and study plan

Nutrition and fitness intervention

Behavioral

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

Primary outcomes

  1. Upper body strength

    Time frame: 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

    • 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

  2. Core strength

    Time frame: 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

  3. Cardiovascular endurance

    Time frame: 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.

Secondary outcomes

  1. Nutrition knowledge

    Time frame: From enrollment to end of 8-week intervention

    Number of correct items on a 10-item multiple choice assessment of nutrition knowledge

  2. Blood Pressure

    Time frame: From enrollment to the end of 8-week intervention

    Blood pressure numbers assessed by school nurses using a manual pediatric cuff

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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