Physical Activity Program for Sedentary Lifestyle

(SPLASH Trial)

Overseen By Breanne Wilhite, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Tufts University

Disqualifiers: Not in 3rd-5th grade, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special physical activity program, called The Rising New York Road Runners program, can boost physical activity levels in school-aged children. The program includes a new school curriculum and activities for families to do together at home. Researchers seek to discover if the program enhances children's abilities and motivation to stay active and whether effects vary by gender or weight. The trial seeks children in 3rd to 5th grade who regularly attend physical education classes at participating schools. Schools will either implement this new program or continue with their standard procedures to compare results. As an unphased trial, this study offers a unique opportunity for children to participate in innovative research that could enhance their health and well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this physical activity program is safe for children?

Research has shown that the Rising New York Road Runners program is fun and easy for kids to join. This running program makes exercise enjoyable. Importantly, no safety issues have been reported, indicating that kids handle it well. The program emphasizes health and safety and receives support from medical experts, enhancing its trustworthiness. Overall, the program appears safe for children and effectively encourages them to be more active at school. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Rising New York Road Runners program because it introduces a unique twist to tackling sedentary lifestyles in schools. Unlike typical physical education options, this program combines a school-based curriculum with family engagement, aiming to create a supportive environment that encourages kids to be active both at school and at home. This dual approach could lead to more sustainable changes in lifestyle, potentially making it more effective in promoting long-term physical activity compared to standard school procedures.

What evidence suggests that this program is effective for increasing physical activity in children?

Research shows that sitting less can lead to more physical activity and better health. In this trial, participants in the intervention arm will engage in The Rising New York Road Runners program. This program helps school-aged children become more active by combining physical education at school with activities they can do at home. Studies suggest that such an approach can improve children's physical skills, confidence, and motivation to be active. By focusing on both school and home, the program aims to create a supportive environment for a more active lifestyle. This method can significantly increase the time children spend being active, which is important for their overall health and well-being. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for children in the 3rd to 5th grade who attend a school participating in the intervention and take part in physical education classes. There are no specific exclusion criteria provided.

Inclusion Criteria

Child attends school participating in the intervention

In the 3rd, 4th or 5th grade

Participates in the school's physical education class

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Baseline Assessment

Children will wear an Actigraph accelerometer for 7 days to measure baseline physical activity levels and fundamental movement skills will be assessed

1 week

1 visit (in-person)

Intervention

Participants receive the Rising New York Road Runners program, a school-based physical education curriculum with a family engagement component

One school year

Follow-up

Participants are monitored for changes in physical literacy and physical activity levels

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• The Rising New York Road Runners program

Trial Overview The trial tests a multilevel physical activity program called Rising New York Road Runners, comparing its impact on kids' physical literacy and activity levels over one year against schools not receiving it.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

The Rising New York Road Runners program: A School-based physical education curriculum with family engagement component.

Group II: Control Active Control 1 Intervention

Standard school operating procedures

Who Is Running the Clinical Trial?

Tufts University

Lead Sponsor

Trials

271

Recruited

595,000+

George Washington University

Collaborator

Trials

263

Recruited

476,000+

Published Research Related to This Trial

In a review of over 5,500 participants from 11 physical activity interventions, no serious study-related adverse events were reported, indicating a high level of safety in these exercise programs.

While minor musculoskeletal injuries were noted, the studies emphasized a 'start low and go slow' approach, suggesting that moderate-intensity physical activity is safe and effective for sedentary, chronically ill, or older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. Ory, M., Resnick, B., Jordan, PJ., et al.[2022]

A study analyzing data from the 1996 Behavioral Risk Factor Surveillance System found that individuals who perceive their neighborhoods as unsafe are more likely to be physically inactive.

Addressing concerns about neighborhood safety could be crucial in promoting physical activity, especially among high-risk populations such as older adults and racial/ethnic minorities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neighborhood safety and the prevalence of physical inactivity--selected states, 1996. [2022]

The American College of Sports Medicine's guidelines for exercise training have historically focused on enhancing aerobic capacity and body composition, but recent research suggests they may not fully address the health needs of sedentary adults.

A new approach emphasizes promoting general physical activity over strict exercise training, as studies show that a more active lifestyle is linked to better health outcomes, longevity, and performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

J.B. Wolffe Memorial Lecture. Health consequences of physical activity: understanding and challenges regarding dose-response. Haskell, WL.[2019]

In a 1.5-year study involving 274 male veterans with cardiovascular disease risk factors, only one serious adverse event (atrial fibrillation) occurred, indicating that a progressive walking program can be safely recommended for high-risk individuals.

While minor musculoskeletal issues were common, over half of the reported adverse events were unrelated to the exercise program, highlighting the need for strategies to help individuals with chronic illnesses safely resume physical activity after any health setbacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. Goodrich, DE., Larkin, AR., Lowery, JC., et al.[2022]

Cardiac rehabilitation, which includes exercise training and potentially other interventions, is effective for patients with coronary heart disease, leading to significant reductions in all-cause and cardiac mortality, nonfatal reinfarction, and hospitalization rates, based on a review of 71 trials involving 13,824 patients.

Despite its effectiveness, certain groups such as the elderly, women, and those with comorbidities are underrepresented in clinical trials, highlighting the need for broader inclusion in future research and the promotion of cardiac rehabilitation by healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise-based cardiac rehabilitation in patients with coronary heart disease: meta-analysis outcomes revisited. Oldridge, N.[2022]

Regular exercise significantly increases markers of exercise capacity, such as VO2max and ventilatory threshold (VT), which can enhance overall quality of life, especially for patients with health limitations.

Exercise serves as a positive health recommendation that not only improves physical fitness but may also indirectly encourage patients to adopt healthier behaviors, contrasting with traditional negative health advice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and exercise training prescriptions for patients. Foster, C., Cadwell, K., Crenshaw, B., et al.[2019]

A 24-week behavioral modification program using pedometers and telephone support significantly increased physical activity by an average of 2744 steps per day and reduced sedentary behavior by 23 minutes per day in type 2 diabetes patients.

These positive changes in physical activity and reduced sedentary time were still evident one year later, with an increase of 1872 steps per day and a decrease of 12 minutes in sedentary behavior, demonstrating the program's lasting impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a pedometer-based behavioral modification program with telephone support on physical activity and sedentary behavior in type 2 diabetes patients. De Greef, KP., Deforche, BI., Ruige, JB., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-physical-inactivity-5-2023-8bc43

Physical Activity Program for Sedentary Lifestyle (SPLASH ... What data supports the effectiveness of the treatment The Rising New York Road Runners program for a sedentary lifestyle? Research shows that physical activity ...

2. nyspmr.org nyspmr.org/wp-content/uploads/2024/10/A-Randomized-Study-of-a-Strength-Training-Program-to-Prevent-Injuries-in-Runners-of-the-New-York-City-Marathon.pdf

A-Randomized-Study-of-a-Strength-Training-Program-to- ... The study found that a 12-week strength training program did not decrease overuse injury incidence resulting in marathon noncompletion.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5511092/

Targeting Reductions in Sitting Time to Increase Physical ... New evidence suggests that reductions in sedentary behavior may increase physical activity and improve health.

4. americashealthrankings.org americashealthrankings.org/explore/measures/Sedentary/NY

Explore Physical Inactivity in New York | AHR In New York, 26.1% of adults reported no physical activity other than their job in the past 30 days, ranking 35th. The US rate is 24.2%.

5. odphp.health.gov odphp.health.gov/sites/default/files/2019-10/Promotion_Q2_Sedentary_Evidence_Portfolio.pdf

Physical Activity Promotion Subcommittee, Question 2 Outcomes Addressed: Lifestyle behavior change: PA (e.g., change in daily minutes of PA), sedentary behavior, and other outcomes, including weight status, ...

6. nyrr.org nyrr.org/youth/aboutrisingnyrr

About Rising New York Road Runners Rising New York Road Runners is a free running-based youth program designed to make physical activity enjoyable and accessible for kids nationwide.

7. nyrr.org nyrr.org/media-center/press-release/2025_0930_nyrrfy25impact

New York Road Runners Celebrates Record-Breaking ... The Rising NYRR Wheelchair Training Program, a free initiative offering training sessions, resources, and events for kids with physical ...

8. athletechnews.com athletechnews.com/nyc-billion-dollar-running-boom-new-york-road-runners/

NYC's Billion-Dollar Running Boom Isn't Slowing Down ... All of NYRR's races are getting harder and harder to get into — especially with its 9+1 program, which provides runners guaranteed entry into ...

9. nyrr.org nyrr.org/tcsnycmarathon/race-day/runner-health-and-safety

Runner Health and Safety at the TCS New York City ... At New York Road Runners, runner health and safety are our top priorities, and we have a comprehensive network of medical professionals and resources in ...

10. guidestar.org guidestar.org/profile/13-2949483

New York Road Runners, Inc. The Rising New York Road Runners Youth Ambassadors program is centered around a six-week speech fundamentals and public-speaking training ...