50K4Life Program for Increasing Physical Activity

Overseen By Kaycee Carmagnani, MSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas, El Paso

Disqualifiers: Works at multiple schools, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 28

406 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to boost walking activity among school employees by testing various supportive strategies. Researchers will divide participants into groups that receive either step challenges alone or in combination with text reminders, remote education, coaching, and group walks. The study seeks full-time school employees without walking limitations who are willing to use a fitness tracker and a smartphone for 18 months. The goal is to identify the most effective way to encourage regular walking in a school setting. As an unphased trial, this study allows participants to contribute to innovative strategies that could enhance health and wellness in educational environments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on increasing physical activity rather than medication use.

What prior data suggests that the 50K4Life Program is safe for increasing physical activity in school employees?

Research has shown that workplace walking programs, such as the 50K4Life, are generally safe. Reviewed studies did not identify any safety issues with these programs, indicating they are manageable for participants. The goal is to encourage more movement, a safe and healthy objective. Participants can feel confident that the program aims to improve well-being without known risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 50K4Life Program because it offers a fresh approach to boosting physical activity through a fun and engaging Walking Challenge. Unlike traditional exercise programs that might require gym memberships or equipment, this program leverages simple, everyday walking combined with innovative support methods. Some variations include personalized SMS text messages and school-level interventions, which add motivation and community support. This multi-faceted approach not only makes staying active more accessible but also taps into social and technological support systems to encourage participants to reach their activity goals.

What evidence suggests that this trial's treatments could be effective for improving walking engagement in school employees?

Studies have shown that the 50K4Life program effectively encourages school employees to walk more. Participants in this trial may join different treatment arms. The program includes a daily walking challenge with a goal of reaching 50,000 steps each week. Some participants will receive text message reminders, while others may experience school-level interventions, such as educational sessions and environmental improvements, to further increase physical activity. Additionally, researchers are testing personal approaches, such as online education and one-on-one coaching, to help improve walking habits. Overall, these flexible strategies aim to overcome obstacles and make regular walking easier in the workplace. ^{1 3 5 6 7}

Who Is on the Research Team?

Jennifer J Salinas, Ph.D., LMSW

Principal Investigator

University of Texas, El Paso

Are You a Good Fit for This Trial?

This trial is for school employees in El Paso, Texas who are interested in increasing their walking activity. Participants will be involved in a study using the '50K4Life' program and possibly SMS text messaging to encourage more walking. Those who don't respond well may receive additional support through individual coaching or school-level interventions.

Inclusion Criteria

Own a smartphone

I am willing to wear a Fitbit or similar device for 18 months.

I work full-time for a school district.

Exclusion Criteria

Schools that previously participated in walking challenges

I work at multiple schools.

Does not work on a district school campus

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Treatment

Participants are randomly assigned to 50K4Life only or 50K4Life + SMS Text Messaging to improve walking engagement

8 weeks

Baseline and 8-week visits

Phase 2: Adaptive Treatment

Non-responder schools receive either individual-level or school-level interventions for 6 months

6 months

8-month visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 months

12-month and 18-month visits

What Are the Treatments Tested in This Trial?

Interventions

• 50K4Life
• Individual
• School
• SMS Text Messaging

Trial Overview The '50K4Life' program aims to boost walking among school workers using activity trackers and motivational strategies. The study has two phases: initially comparing the effectiveness of the program with or without SMS reminders, then offering extra help to schools that need it through personal coaching or group activities.

How Is the Trial Designed?

Group I: Phase 2. Walking Challenge only Experimental Treatment 1 Intervention

Participants meeting the step goal in Phase 1(WC only) will continue into Phase 2 without change.

Group II: Phase 2. Walking Challenge + SMS Text Messages Experimental Treatment 2 Interventions

Participants meeting their step goal in Phase 1 (WC + SMS Text Messages) will continue into Phase 2 without change.

Group III: Phase 2. 50K4Life + SMS Text Messages + Schools Experimental Treatment 3 Interventions

Walking Challenge + SMS Messages + School-level interventions

Group IV: Phase 2. 50K4Life + SMS Text Messages + Individual Experimental Treatment 3 Interventions

Walking Challenge + SMS Messages + Individual level interventions

Group V: Phase 2. 50K4LIfe + School Experimental Treatment 2 Interventions

Walking Challenge + School-level interventions

Group VI: Phase 2. 50K4LIfe + Individual Experimental Treatment 2 Interventions

Walking Challenge + Individual level interventions.

Group VII: Phase 1. 50K4Life + SMS Text Messages Experimental Treatment 2 Interventions

Walking Challenge + SMS Messages

Group VIII: Phase 1. 50K4LIfe Only Experimental Treatment 1 Intervention

Walking Challenge only

50K4Life is already approved in United States for the following indications:

Approved in United States as 50K4Life for:

• Physical Activity Improvement
• Walking Engagement Enhancement

Who Is Running the Clinical Trial?

University of Texas, El Paso

Lead Sponsor

Trials

17

Recruited

3,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

A 16-week pilot study involving 97 physically inactive employees tested a peer-led workplace walking intervention, showing that the enhanced treatment group had improvements in cardio-metabolic risk factors, while the minimal treatment group did not.

Both groups experienced an increase in autonomous motivation to walk, but there were no significant changes in step counts, standing, sitting time, or overall well-being, indicating that further adjustments to the intervention are needed for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary effects of a peer-led motivationally-embellished workplace walking intervention: A pilot cluster randomized trial (the START trial). Thøgersen-Ntoumani, C., Quested, E., Smith, BS., et al.[2021]

Baseline physical activity levels did not significantly predict participation in worksite walking clubs, indicating that these programs can attract employees regardless of their initial activity levels.

Older employees and those with more social support were more likely to join walking clubs, while younger men and employees from certain worksites showed lower participation rates, suggesting a need for targeted outreach to engage these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is baseline physical activity a determinant of participation in worksite walking clubs? Data from the HealthWorks Trial. VanWormer, JJ., Linde, JA., Harnack, LJ., et al.[2021]

A 12-week worksite physical activity intervention aimed at achieving 10,000 steps per day led to significant reductions in body mass index (BMI) and improvements in blood pressure among university employees, particularly benefiting those already at risk for cardiovascular disease (CVD).

Despite some unfavorable changes in plasma biomarkers, participants at risk for CVD experienced greater reductions in systolic and diastolic blood pressure, as well as improvements in other cardiovascular risk factors, indicating the intervention's potential effectiveness in this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a 12-week worksite physical activity intervention on anthropometric indices, blood pressure indices, and plasma biomarkers of cardiovascular disease risk among university employees. Corbett, DB., Fennell, C., Peroutky, K., et al.[2018]

A 16-week lunchtime walking intervention for insufficiently active university employees aimed to increase walking behavior and improve well-being and work performance, with participants engaging in three 30-minute group walks per week.

The study's results will help assess the feasibility of such programs, potentially leading to larger trials that could enhance health and productivity in various workplaces.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Step by Step". A feasibility study of a lunchtime walking intervention designed to increase walking, improve mental well-being and work performance in sedentary employees: Rationale and study design. Thøgersen-Ntoumani, C., Loughren, EA., Duda, JL., et al.[2021]

The 'A Million Steps' program successfully encouraged employees from two Spanish companies to increase their physical activity, with participants achieving the goal of walking at least a million steps in a month.

Workers reported that the program not only improved their physical activity levels but also enhanced motivation and social interactions among colleagues, contributing to overall well-being and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Million Steps: Developing a Health Promotion Program at the Workplace to Enhance Physical Activity. González-Dominguez, ME., Romero-Sánchez, JM., Ares-Camerino, A., et al.[2018]

A four-month workplace health program using pedometers led to significant improvements in physical activity levels, with a 6.5% increase in participants meeting activity guidelines, and reductions in blood pressure and waist circumference.

While the program improved several health markers, it also resulted in a slight increase in fasting total cholesterol and triglycerides, indicating the need for further long-term evaluation of its overall impact on chronic disease prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a pedometer-based workplace health program on cardiovascular and diabetes risk profile. Freak-Poli, R., Wolfe, R., Backholer, K., et al.[2022]

In a pilot study involving 27 participants with stable COPD, a program using a pedometer and website successfully increased daily walking by an average of 1263 steps (about 1.0 km) over 90 days, demonstrating its efficacy.

The program was found to be safe and feasible, with 87% of participants reporting no issues using the pedometer and 95% expressing a willingness to recommend the program to others with COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of an Internet walking program and pedometer in COPD. Moy, ML., Weston, NA., Wilson, EJ., et al.[2022]

Patients receiving physical activity on prescription (PAP) in Sweden reported significant increases in their physical activity levels at six and twelve months, with a trend continuing at 24 months, indicating the effectiveness of PAP in promoting exercise.

The study also found that patients experienced clinically relevant improvements in quality of life across several domains, such as physical role limitation and vitality, which persisted for up to 24 months, highlighting the long-term benefits of PAP in primary healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity on prescription (PAP): self-reported physical activity and quality of life in a Swedish primary care population, 2-year follow-up. Rödjer, L., H Jonsdottir, I., Börjesson, M.[2018]

A 20-week pedometer-based physical activity intervention in a European workplace showed that participants in the intervention group had a significantly smaller decrease in daily step counts compared to a comparison group, indicating some effectiveness in maintaining activity levels.

The intervention was particularly beneficial for already active participants who were reaching 10,000 steps per day at baseline, suggesting that future programs should focus more on engaging inactive employees to improve overall participation and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a multi-strategy workplace physical activity intervention promoting pedometer use and step count increase. De Cocker, KA., De Bourdeaudhuij, IM., Cardon, GM.[2022]

Over 30% of staff (1195 participants) in a workplace pedometer program increased their walking levels, with the most significant improvements seen in those who initially walked the least.

The program not only helped participants maintain higher walking levels over time but also encouraged them to involve family members, demonstrating its effectiveness in promoting physical activity and raising awareness about its importance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting physical activity in the workplace: using pedometers to increase daily activity levels. Thomas, L., Williams, M.[2019]

The '3,000 more steps' intervention significantly increased daily steps from an average of 5,811 to 9,240 among 39 out of 70 sedentary office workers who completed the 8-week program, indicating its efficacy in promoting physical activity.

Completers of the program also experienced reductions in fat mass, waist-hip ratio, and body mass index (BMI), while non-completers had lower physical activity levels and higher fat mass at the start, suggesting that initial health status may influence program adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of an Academic--Workplace Partnership Intervention to Promote Physical Activity in Sedentary Office Workers. Chae, D., Kim, S., Park, Y., et al.[2018]

A systematic review of 38 studies involving 3777 participants with chronic airways disease showed that interventions promoting physical activity significantly increased daily step counts by a median of 705 steps compared to standard care.

Interventions that included wearable activity monitors were particularly effective, resulting in a higher increase in step counts (SMD 0.37), highlighting the importance of technology in encouraging physical activity among individuals with chronic airways disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity promotion interventions in chronic airways disease: a systematic review and meta-analysis. Reilly, C., Sails, J., Stavropoulos-Kalinoglou, A., et al.[2023]

In a study involving 7118 participants with impaired glucose tolerance, each additional 2000 steps taken daily was linked to a 5.5% lower risk of developing diabetes, highlighting the importance of physical activity in diabetes prevention.

The findings suggest that physical activity should be objectively measured in clinical trials and incorporated into regular clinical practice, as it significantly influences diabetes outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between baseline physical activity assessed by pedometer count and new-onset diabetes in the NAVIGATOR trial. Kraus, WE., Yates, T., Tuomilehto, J., et al.[2022]

A novel Internet-mediated, pedometer-based exercise intervention for veterans with COPD led to significant improvements in health-related quality of life (HRQL) domains, particularly in Symptoms and Impact, after 4 months.

Participants in the intervention group increased their daily step counts by an average of 779 steps compared to the control group, indicating that the program effectively encouraged physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Internet-Mediated Pedometer-Based Program Improves Health-Related Quality-of-Life Domains and Daily Step Counts in COPD: A Randomized Controlled Trial. Moy, ML., Collins, RJ., Martinez, CH., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06411769

Evidence-based Intervention to Improve Walking ... The investigators will test if the 50,000 for Life (50K4Life) is effective at improving walking engagement in school employees in 30 public schools by ...

2. papers.ssrn.com papers.ssrn.com/sol3/Delivery.cfm/8f518cb5-be62-4d4e-a3db-fa27fb5eec03-MECA.pdf?abstractid=5360257&mirid=1

50k4Life Methods: We plan to conduct a clustered Sequential Multiple Assignment Randomized Trial. (SMART) to determine the effectiveness of a workplace walking challenge ...

3. withpower.com withpower.com/trial/phase-physical-activities-7-2025-f7930

50K4Life Program for Increasing Physical Activity The investigators will test if the 50,000 for Life (50K4Life) is effective at improving walking engagement in school employees in 30 public schools by ...

4. apha.confex.com apha.confex.com/apha/2024/meetingapi.cgi/Paper/546763?filename=2024_Abstract546763.pdf&template=Word

Abstract The objective of this study is to assess the effectiveness of the 50K4Life Workplace Walking Challenge Study by delivering a two-phased adaptive ...

5. trial.medpath.com trial.medpath.com/clinical-trial/ccac3a7c5f2273a3/nct06411769-evidence-based-intervention-walking-engagement-el-paso

Evidence-based Intervention to Improve Walking Engagement ... The investigators will test if the 50,000 for Life (50K4Life) is effective at improving walking engagement in school employees in 30 public schools by ...

6. papers.ssrn.com papers.ssrn.com/sol3/papers.cfm?abstract_id=5360257

50k4life: A Smart Study Protocol to Improve Walking ... Workplace-based programs can increase moderate to vigorous physical activity (MVPA) engagement while addressing barriers associated with ...

7. reporter.nih.gov reporter.nih.gov/search/2Ek7YrB4xEqBDPQSsDLbPQ/project-details/11061253

Project Details We plan to conduct a clustered Sequential Multiple Assignment Randomized Trial (SMART) to determine the effectiveness of an employer-based walking challenge ...