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

435 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Fee Waiver + Outreach for Increasing Physical Activity?

Research shows that increasing physical activity, even without weight loss, can reduce obesity-related health risks and improve fitness. Financial incentives and support, like fee waivers and outreach, have been effective in encouraging healthier behaviors, such as increased physical activity, especially in underserved populations. ^{1 2 3 4 5}

Is the Fee Waiver + Outreach treatment generally safe for increasing physical activity?

Research on physical activity interventions, including those with fee waivers and outreach, shows that while minor injuries like muscle strains can occur, no serious adverse events have been reported. It's important to start with moderate intensity and gradually increase activity levels to minimize risks. ^{6 7 8 9 10}

How does the Fee Waiver + Outreach treatment increase physical activity differently from other treatments?

The Fee Waiver + Outreach treatment is unique because it combines financial incentives (fee waivers) with personalized support (intensive outreach) to encourage physical activity, which is different from other treatments that may focus solely on counseling or recreational activities without financial or personalized support components. ^{2 11 12 13 14}

What is the purpose of this trial?

To evaluate a park-level intervention to increase child moderate/vigorous physical activity (MVPA), and decrease sedentary time among low-income racially/ethnically diverse children ages 6-12 yrs. Neighborhood parks (n=20) from Minneapolis (n=8) and Saint Paul (n=12) park systems will be randomized for a 2-year period to one of two arms: 1) Intensive Park Outreach and Youth Sports Program Fee Waiver (n=10); or 2) Youth Sports Program Fee Waiver Only (n=10). The evaluation cohort will consist of 432 children ages 6-12 yrs who reside in one of the 20 randomized park neighborhoods. Measurements from evaluation cohort-enrolled individual children will be collected at baseline, 6, 12, and 24 months.

Research Team

Simone A French, PhD

Principal Investigator

University of Minneaots

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The future of obesity reduction: beyond weight loss. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Strategies to Increase Physical Activity. [2022]

3. England pubmed.ncbi.nlm.nih.gov

RE-AIM evaluation of the Veterans Health Administration's MOVE! Weight Management Program. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The cost of integrating a physical activity counselor in the primary health care team. [2012]

5. United States pubmed.ncbi.nlm.nih.gov

The Efficacy of Using Financial Incentives to Change Unhealthy Behaviors Among a Rural Chronically Ill and Uninsured Population. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Increasing Trainee Reporting of Adverse Events With Monthly Trainee-Directed Review of Adverse Events. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

Exploring participants' perspectives on adverse events due to resistance training: a qualitative study. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Recreational Physical Activity Improves Adherence and Dropout in a Non-Intensive Behavioral Intervention for Adolescents With Obesity. [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Print versus website physical activity programs: a randomized trial. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Instant Recess®: a practical tool for increasing physical activity during the school day. [2011]

14. Canada pubmed.ncbi.nlm.nih.gov

Development and usability testing of an internet intervention to increase physical activity in overweight adolescents. [2021]