Fee Waiver + Outreach for Increasing Physical Activity

(PARKS Trial)

Overseen By Nancy E Sherwood, PhD

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Minnesota

Disqualifiers: Age, Location, Physical activity, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests ways to help children become more active by using local parks. It focuses on kids aged 6-12 who don't get enough exercise and live near certain parks in Minneapolis and Saint Paul. The trial examines two approaches: one group receives free access to sports programs (Fee Waiver), while the other group receives additional community support to help parents and kids get involved (Fee Waiver Plus Intensive Outreach). Children who are healthy enough for physical activity and plan to stay in the area for two years might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially impactful community health solution.

Do I need to stop taking my current medications to join the trial?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both the "Fee Waiver" and "Fee Waiver Plus Intensive Outreach" programs are safe. These programs aim to increase youth sports participation by removing financial barriers, without introducing new medications or physical treatments.

Studies have found that making sports programs free leads to more participation. For instance, one study showed a twelvefold increase in applications when fees were waived. This increase means more kids join and stay active, which is important for their health.

Since these programs focus on making sports accessible, they don't have the side effects that medical treatments might have. No reports have linked negative effects directly to these fee waivers and outreach efforts. The main goal is to encourage kids to be more active, which is generally safe and beneficial.

Overall, the programs are well-received because they aim to get kids moving by making sports easier to join and enjoy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative strategies to boost physical activity among youth. The Fee Waiver Plus Intensive Outreach approach is unique in its community-focused strategy, where a community advisory group actively engages with local partners to support and encourage participation in youth sports programs. This method not only removes financial barriers by waiving fees but also enhances communication and engagement through bilingual materials and technical support for coaches. Unlike traditional approaches that might focus solely on providing access, this trial aims to create a supportive environment to maximize participation and engagement.

What evidence suggests that this trial's treatments could be effective for increasing physical activity in children?

Research has shown that removing fees for youth sports programs greatly increases participation. One study found that applications increased twelvefold when fees were removed, indicating that cost is a significant obstacle for many families. In this trial, one group will receive a fee waiver for youth sports programs, while another group will receive both a fee waiver and intensive community outreach. By combining fee waivers with active community outreach, the researchers expect even more families to get involved. This approach aims to help children become more physically active, which is important for their health. Overall, both removing fees and reaching out to the community are promising ways to encourage more kids to be active and spend less time sitting. ^{2 3 5 6 7}

Who Is on the Research Team?

Simone A French, PhD

Principal Investigator

University of Minneaots

Are You a Good Fit for This Trial?

This trial is for kids aged 6-12 who live near one of the 24 study parks, can be physically active but don't currently meet recommended activity levels. They shouldn't plan to move in the next two years or already be as active as guidelines suggest.

Inclusion Criteria

Do not meet guidelines for recommended level of physical activity

I am between 6 and 12 years old.

I can perform daily activities without assistance.

Exclusion Criteria

Do not live within 2 miles of study park

Plan to move within two years

I am unable to be physically active.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Measurement

Baseline measurements of physical activity and sedentary behavior are collected using accelerometers

1 week

1 visit (in-person)

Intervention

Implementation of park-level interventions including Intensive Outreach and Youth Sports Program Fee Waiver

24 months

Ongoing community engagement and program participation

Follow-up

Participants are monitored for changes in physical activity and sedentary behavior at 6, 12, and 24 months

24 months

3 visits (in-person) at 6, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Fee Waiver
• Fee Waiver Plus Intensive Outreach

Trial Overview The study tests if waiving sports program fees at local parks and adding intensive family outreach can boost physical activity among low-income, diverse children. Parks are randomly chosen to either just waive fees or also do outreach for two years.

How Is the Trial Designed?

Group I: Fee Waiver Plus Intensive Outreach Experimental Treatment 1 Intervention

Parks randomly assigned to the Intensive Outreach and Fee Waiver: Intensive Outreach consists of the formation and activity of a community advisory group who will engage with neighborhood community partners to support parents in the neighborhood to enroll their child and support the child's participation in the park youth sports programs offered at the neighborhood park and recreation center. Program marketing and materials and registration will be offered in both Spanish and English. Program coaches will be supported with technical assistance from study staff to implement the park youth sports program with high fidelity and with high communication and engagement with enrolled youth and their parents. Fees for youth sports programs will be waived in this condition. Youth who enroll in youth sports programs in parks that are randomly assigned to this condition will pay no fee for program enrollment.

Group II: Fee Waiver Experimental Treatment 1 Intervention

Fees for youth sports programs will be waived in this condition. Youth who enroll in youth sports programs in parks that are randomly assigned to this condition will pay no fee for program enrollment.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

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]

Participants with chronic health conditions expressed that adverse events (AEs) from resistance training (RT) significantly impact their willingness to engage in future exercise, highlighting the importance of understanding both the risks and benefits of RT.

The study identified that personal experiences, health conditions, and the environment in which RT occurs influence perceptions of safety and participation, suggesting that better communication about the risks of AEs is essential to encourage RT among individuals with chronic health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring participants' perspectives on adverse events due to resistance training: a qualitative study. El-Kotob, R., Pagcanlungan, JR., Craven, BC., et al.[2023]

An 8-week randomized trial involving 655 university staff found no significant overall increase in physical activity from either a print or a web-based intervention, indicating that both methods may be equally ineffective in increasing activity levels.

However, the print program was effective for participants who were inactive at the start, showing a significant increase in physical activity, while the web program led to a notable decrease in sitting time, suggesting different impacts based on the delivery method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Print versus website physical activity programs: a randomized trial. Marshall, AL., Leslie, ER., Bauman, AE., et al.[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]

Researchers in resistance training studies often lack clear guidance and motivation for thorough adverse event (AE) reporting, which can lead to inconsistent practices.

There is a need for exercise-specific guidelines for AE reporting, as current standards are perceived as not applicable to exercise trials, highlighting the importance of tailored strategies to improve reporting consistency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. El-Kotob, R., Pagcanlungan, JR., Craven, BC., et al.[2022]

A 22-month study showed that trainee-led monthly conferences significantly increased the reporting of adverse events by medical trainees, with submissions rising from an average of 6.7 to 14.1 reports per month (P < .001).

These conferences not only improved reporting rates but also empowered trainees to identify system vulnerabilities and propose meaningful solutions, enhancing overall patient safety in the hospital setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Trainee Reporting of Adverse Events With Monthly Trainee-Directed Review of Adverse Events. Smith, A., Hatoun, J., Moses, J.[2022]

A web-based program called Young & Active was developed to increase physical activity among overweight adolescents, incorporating features like self-monitoring, autonomy-supportive counseling, and social support forums, based on theories of self-determination and motivational interviewing.

Usability testing with adolescents aged 12-16 showed that the program was well accepted after iterative adjustments, indicating a strong foundation for further evaluation of its efficacy in a controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and usability testing of an internet intervention to increase physical activity in overweight adolescents. Riiser, K., Løndal, K., Ommundsen, Y., et al.[2021]

The MOVE! Weight Management Program for Veterans has significantly increased the screening and treatment of obesity among eligible patients in the Veterans Health Administration, with participation in weight management visits doubling since its implementation, although it has stabilized at only 10-12%.

Among patients who attended at least two treatment visits, 18.6% achieved a 5% weight loss within 6 months, compared to only 12.5% in a matched comparison group not receiving MOVE!, indicating that the program has a positive but modest impact on weight loss outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RE-AIM evaluation of the Veterans Health Administration's MOVE! Weight Management Program. Kahwati, LC., Lance, TX., Jones, KR., et al.[2022]

A lifestyle-modification program that includes increased physical activity and a balanced diet can significantly reduce obesity-related health risks, even if there is minimal or no weight loss.

Such lifestyle changes can lead to improvements in abdominal obesity, visceral fat, and cardiometabolic risk factors, as well as increases in muscle mass and cardiorespiratory fitness, highlighting the importance of focusing on health improvements rather than just weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The future of obesity reduction: beyond weight loss. Ross, R., Bradshaw, AJ.[2021]

Citations

1. sph.cuny.edu sph.cuny.edu/life-at-sph/news/2024/02/28/reaching-federal-youth-sport-participation-goal-could-save-u-s-billions-of-dollars/

Reaching federal youth sport participation goal could save ... For example, just increasing youth sports participation back to pre-COVID levels, 58.4%, could save a total of $29.17 billion. Youth sports ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6559353/

Perspectives on High School "Pay to Play" Sports Fee Policies In 2014, SHPPS data indicated that 38% of high schools charge fees and the percentage of schools with waivers decreased to 80% (28). Results from the Michigan ...

3. researchgate.net researchgate.net/publication/306074355_Effects_of_a_Facilitated_Fee_Waiver_Program_on_Participation_in_Youth_Sports_Programs

Effects of a Facilitated Fee Waiver Program on Participation ... The demonstration found that a “facilitated waiver program” had a dramatic effect on waiver applications; a twelvefold increase was observed.

4. activelivingresearch.org activelivingresearch.org/effects-facilitated-fee-waiver-program-participation-youth-sports-programs

Effects of a Facilitated Fee Waiver Program on Participation ... The demonstration found that a “facilitated waiver program” had a dramatic effect on waiver applications; a twelvefold increase was observed. Waiver ...

5. tandfonline.com tandfonline.com/doi/abs/10.1080/01490400.2019.1700573

Parental perceptions of a national program that funds sport ... Financial support helped parents facilitate their children's sport participation, which yielded important social benefits for both parents and children. However ...

6. trialx.com trialx.com/clinical-trials/listings/253208/neighborhood-park-youth-sports-program-fee-waiver-and-intensive-family-outreach/

Neighborhood Park Youth Sports Program Fee Waiver and ... This research evaluates the effects of a park-level intervention to increase child moderate/vigorous physical activity (MVPA), and decrease ...

7. health.gov health.gov/sites/default/files/2020-09/YSS_ScienceBoardReport_2020.09.01_opt.pdf

PCSFN Science Board Report on Youth Sports 1 The NYSS provides a variety of opportunities and action items to unite the nation's youth sports culture around a shared vision: that one day ...