A School-Based Nutrition and Fitness Program: Operation ToneUp
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-14
SponsorArizona State University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Nutrition and fitness intervention
BehavioralSchool-based nutrition and fitness program using interactive web platform twice weekly for 20 minutes each session delivered in classroom settings.
Treatment groups
1,400 Participants
are divided into 2 treatment groupsGroup A: Operation ToneUp ArmExperimental treatment 1 intervention
Group B: Comparison ArmNo intervention 0 interventions
Trial outcomes
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 intervention2
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 intervention3
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 interventionSecondary 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 intervention2
Blood Pressure
Blood pressure numbers assessed by school nurses using a manual pediatric cuff
Time frame
From enrollment to the end of 8-week interventionSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: