ExerciseNCT07803666
A School-Based Nutrition and Fitness Program: Operation ToneUp
A study testing Nutrition and fitness intervention in people with Exercise and Nutrition Knowledge, run by Arizona State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 14 years
- Conditions the study is for
- Exercise, Nutrition Knowledge, Blood Pressure
- What is being tested?
- Nutrition and fitness intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Lake Havasu Unified School District
Lake Havasu City, Arizona, 86403
Tony Lamka, 602-432-2398, tony@operationtoneup.com
About this study
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?
Read more
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
- Conditions
- Exercise, Nutrition Knowledge, Blood Pressure
- Being tested
- Nutrition and fitness intervention
- Keywords
- Exercise, Food, Blood pressure
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition and fitness interventionBehavioural
School-based nutrition and fitness program using interactive web platform twice weekly for 20 minutes each session delivered in classroom settings.
| Study group | Role | What they receive |
|---|---|---|
| Operation ToneUp Arm | Experimental | 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. Receives: Behavioral: Nutrition and fitness intervention |
| Comparison Arm | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Upper body strength
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
Measured: From enrollment to end of 8-week intervention
Core strength
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
Measured: From enrollment to end of 8-week intervention
Cardiovascular endurance
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.
Measured: From enrollment to end of 8-week intervention
Secondary outcomes (2)
Nutrition knowledge
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.
Measured: From enrollment to end of 8-week intervention
Blood Pressure
Blood pressure numbers assessed by school nurses using a manual pediatric cuff
Measured: From enrollment to the end of 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allison Poulos, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803666
- Sponsor's protocol ID
- STUDY00024777
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets associated with this study will be publicly available through the Arizona State University Library Research Data Repository.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A School-Based Nutrition and Fitness Program: Operation ToneUp
- ClinicalTrials.gov ID
- NCT07803666
- Acronym / sponsor ID
- STUDY00024777
- Conditions
- Exercise, Nutrition Knowledge, Blood Pressure
- Keywords
- Exercise, Food, Blood pressure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operation ToneUp Arm | Experimental | Behavioral: Nutrition and fitness interventionStudents 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. |
| Comparison Arm | No intervention | –Students in the comparison arm will not be exposed to the Operation ToneUp intervention and will continue with typical classroom sessions during school. |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition and fitness interventionSchool-based nutrition and fitness program using interactive web platform twice weekly for 20 minutes each session delivered in classroom settings. | Behavioural | Operation ToneUp Arm |
Primary outcome
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
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
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.
2 secondary outcomes
Nutrition knowledge
Time frame: From enrollment to end of 8-week intervention
Blood Pressure
Time frame: From enrollment to the end of 8-week intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Yes. The data sets associated with this study will be publicly available through the Arizona State University Library Research Data Repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lake Havasu Unified School District
Lake Havasu City, United States
Allison Poulos, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition and fitness intervention in people with Exercise and Nutrition Knowledge, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper body strength (time frame: From enrollment to end of 8-week intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.