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Not yet recruitingNCT07803666Updated Sep 9, 2026

A School-Based Nutrition and Fitness Program: Operation ToneUp

An interventional study of Nutrition and fitness intervention in Exercise, Nutrition Knowledge and Blood Pressure, sponsored by Arizona State University. Not yet recruiting at 1 site in United States. Open to participants aged 9 Years to 14 Years. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Arizona State University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,400
Allocation
Randomized
Ages
9 Years to 14 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 27 studies in Motor Activity by Arizona State University — 5 open to participants now, 6 under way, none of them phase 3. Motor Activity · Arizona State University.

Planned enrollment
2nd of 26
1,400 · median 141
Started
2026
the only one that year
No phase
24 of 27
4 open now
Registered
27th of 27
by date

Among the 27 studies in Motor Activity by Arizona State University, this one is the 2nd largest by planned enrollment of the 26 interventional ones, is the only one that started in 2026, is one of 24 with no phase, and was the 27th registered.

By phase

27 studies; the count open now beside each. This study's row is marked.

No phasethis study24 · 4 open
Observational1 · 0 open
Phase 21 · 1 open
Phase 41 · 0 open

By the year they started

First in 2005; this study’s year is marked. 1 started in 2026.

Size and results

Median enrollment 141 across the 26 interventional studies, 67 across the 1 observational. Of the 21 that completed or were terminated, 2 (10%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 27 studies in Motor Activity by Arizona State University, or all of them as a file.
02

Study 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
03

Conditions studied

  • Exercise
  • Nutrition Knowledge
  • Blood Pressure

Browse trials for

Keywords

  • Exercise
  • Food
  • Blood pressure
04

Who can participate

Ages eligible
9 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,400 participants (estimated)

Study arms

  • 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

  • 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.

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.

06

What researchers measure

Primary outcomes

  1. 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

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

  2. 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

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

  3. 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.

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

Secondary outcomes

  1. 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.

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

  2. Blood Pressure

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

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

07

Study locations

1 site
  • Lake Havasu Unified School District
    Lake Havasu City, Arizona 86403, United States
08

References and documents

Individual participant data

Plan to share: Yes — The data sets associated with this study will be publicly available through the Arizona State University Library Research Data Repository.

Supporting information: Study protocol

Time frame: Beginning at the time of first publication

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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for May 2027, 8 months later.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 8 months is below that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2026
First posted
Sep 4, 2026
StartEst.
Sep 2026
Primary completionEst.
May 2027
CompletionEst.
Jul 2027
Last update
Sep 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07803666
Responsible party
Sponsor
First posted
Sep 4, 2026
Start date
Sep 2026 (estimated)
Primary completion
May 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Sep 9, 2026

Study contacts

Allison Poulos, PhD
principal investigator · Arizona State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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