A School-Based Nutrition and Fitness Program: Operation ToneUp

August 31, 2026 updated by: 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:

  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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Lake Havasu City, Arizona, United States, 86403

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Nutrition and fitness intervention
School-based nutrition and fitness program using interactive web platform twice weekly for 20 minutes each session delivered in classroom settings.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to end of 8-week intervention
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
From enrollment to end of 8-week intervention
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.
From enrollment to end of 8-week intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to end of 8-week intervention
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
From enrollment to the end of 8-week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arizona State University

Investigators

  • Principal Investigator: Allison Poulos, PhD, Arizona State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

August 31, 2026

First Submitted That Met QC Criteria

August 31, 2026

First Posted (Actual)

September 4, 2026

Study Record Updates

Last Update Posted (Actual)

September 4, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00024777

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sets associated with this study will be publicly available through the Arizona State University Library Research Data Repository.

IPD Sharing Time Frame

Beginning at the time of first publication

IPD Sharing Access Criteria

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 Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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