A School-Based Nutrition and Fitness Program: Operation ToneUp

NCT07803666 | Not Yet Recruiting

• 1 other identifier: STUDY00024777
• Study Type: interventional
• Target: 1,400
• Locations: 1 country
• Sites: 1

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:

• 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

Keywords

Exercise; Food; Blood pressure

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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.

  From enrollment to end of 8-week intervention

Secondary Outcomes (2)

• Nutrition knowledge

  From enrollment to end of 8-week intervention

• Blood Pressure

  From enrollment to the end of 8-week intervention

Study Arms (2)

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.

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.

Interventions

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.

Operation ToneUp Arm

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Lake Havasu Unified School District

Lake Havasu City, Arizona, 86403, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Allison Poulos, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 4, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)