A School-Based Nutrition and Fitness Program: Operation ToneUp
2026年9月3日 更新者：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:
- 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
研究概览
研究类型
介入性
注册 (估计的)
1400
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Arizona
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Lake Havasu City、Arizona、美国、86403
- Lake Havasu Unified School District
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接触：
- Tony Lamka
- 电话号码：602-432-2398
- 邮箱：tony@operationtoneup.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
不
描述
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:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
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School-based nutrition and fitness program using interactive web platform twice weekly for 20 minutes each session delivered in classroom settings.
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无干预：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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Upper body strength
大体时间：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
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From enrollment to end of 8-week intervention
|
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Core strength
大体时间：From enrollment to end of 8-week intervention
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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
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From enrollment to end of 8-week intervention
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Cardiovascular endurance
大体时间：From enrollment to end of 8-week intervention
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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.
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From enrollment to end of 8-week intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Blood Pressure
大体时间：From enrollment to the end of 8-week intervention
|
Blood pressure numbers assessed by school nurses using a manual pediatric cuff
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From enrollment to the end of 8-week intervention
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Nutrition knowledge
大体时间：From enrollment to end of 8-week intervention
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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.
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From enrollment to end of 8-week intervention
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Allison Poulos, PhD、Arizona State University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2027年5月1日
研究完成 (估计的)
2027年7月1日
研究注册日期
首次提交
2026年8月31日
首先提交符合 QC 标准的
2026年8月31日
首次发布 (实际的)
2026年9月4日
研究记录更新
最后更新发布 (实际的)
2026年9月9日
上次提交的符合 QC 标准的更新
2026年9月3日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
The data sets associated with this study will be publicly available through the Arizona State University Library Research Data Repository.
IPD 共享时间框架
Beginning at the time of first publication
IPD 共享访问标准
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 共享支持信息类型
- 研究方案
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.