50K4Life Program for Increasing Physical Activity

Overseen By Kaycee Carmagnani, MSW

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Texas, El Paso

Disqualifiers: Works at multiple schools, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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 delivering a two-phased adaptive intervention to improve walking engagement in school workers in 30 public schools. In Phase 1, all study schools will be randomly assigned to a 50K4Life only, or 50K4Life + SMS Text Messaging group. In Phase 2, non-responder schools will be randomly assigned to one of two 6-month adaptive treatments: a) an individual-level intervention that includes remote education modules (REM) and one-to-one monthly phone-based coaching, or, b) a school-level intervention that includes group educational sessions, school environmental modifications (floor distance markings, signage in corridors and breakrooms, promotional items), and work time/weekend group walks/hikes. The schools that 50% or more participants who achieve 50,000 steps in one week will continue with the Phase 1 condition. Intervention strategies will be coordinated by health educators and managed using the Pathverse app. Data collection will occur at baseline, 8 weeks (Phase 2 randomization decision point), 8 months (immediate post intervention), 12 months (4 months post-intervention), and 18 months (10 months post-intervention) for a total of 18 months of study participation.

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 data supports the effectiveness of the 50K4Life treatment for increasing physical activity?

Research shows that programs using pedometers and internet-based support can increase physical activity and improve health outcomes, such as in people with COPD (a lung disease). These findings suggest that similar approaches, like the 50K4Life program, could effectively boost physical activity. ^{1 2 3 4 5}

Is the 50K4Life Program for Increasing Physical Activity safe for humans?

The studies reviewed did not report any safety concerns related to workplace walking interventions, suggesting they are generally safe for participants. ^{6 7 8 9 10}

How is the 50K4Life treatment different from other treatments for increasing physical activity?

The 50K4Life program is unique because it focuses on a workplace walking challenge, encouraging participants to increase their physical activity through group walks and motivational support, which is different from other treatments that may not emphasize group dynamics or workplace settings. ^{6 11 12 13 14}

Research Team

Jennifer J Salinas, Ph.D., LMSW

Principal Investigator

University of Texas, El Paso

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• 50K4Life (Behavioural Intervention)
• Individual (Behavioural Intervention)
• School (Behavioural Intervention)
• SMS Text Messaging (Behavioural Intervention)

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.

Participant Groups

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

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+

Findings from Research

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 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]

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]

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]

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]

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 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]

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]

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]

References

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

A pilot study of an Internet walking program and pedometer in COPD. [2022]

2. United States 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. [2018]

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

Physical activity promotion interventions in chronic airways disease: a systematic review and meta-analysis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Relationship between baseline physical activity assessed by pedometer count and new-onset diabetes in the NAVIGATOR trial. [2022]

5. United States 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. [2022]

6. United States 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). [2021]

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

Impact of a pedometer-based workplace health program on cardiovascular and diabetes risk profile. [2022]

8. England 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. [2018]

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

The Effects of an Academic--Workplace Partnership Intervention to Promote Physical Activity in Sedentary Office Workers. [2018]

10. England pubmed.ncbi.nlm.nih.gov

The effect of a multi-strategy workplace physical activity intervention promoting pedometer use and step count increase. [2022]

11. Australia pubmed.ncbi.nlm.nih.gov

Promoting physical activity in the workplace: using pedometers to increase daily activity levels. [2019]

12. England 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. [2021]

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

A Million Steps: Developing a Health Promotion Program at the Workplace to Enhance Physical Activity. [2018]

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

Is baseline physical activity a determinant of participation in worksite walking clubs? Data from the HealthWorks Trial. [2021]