Mobile App Support for Physical Activity

(STRIDES Trial)

Overseen By Courtney Monroe, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of South Carolina

Must not be taking: Insulin

Disqualifiers: Pregnancy, Heart condition, Dementia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

300 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a medical condition that affects the safety of a physical activity program, you may not be eligible to participate.

What data supports the effectiveness of the Mobile STRIDES app treatment?

Research shows that mobile apps and wearable devices, like Fitbits, can help people increase their physical activity by providing continuous self-monitoring and feedback. This suggests that the Mobile STRIDES app might also be effective in encouraging more physical activity. ^{1 2 3 4 5}

Is the Mobile STRIDES app safe for use in physical activity programs?

Research on physical activity interventions, including those using mobile apps, shows that serious adverse events are rare, with most issues being minor, like muscle strains. It's important to start slowly and gradually increase activity levels to minimize risks. ^{6 7 8 9 10}

How is the Mobile STRIDES app treatment different from other treatments for increasing physical activity?

The Mobile STRIDES app is unique because it leverages mobile health technology to promote physical activity through features like real-time support, feedback, and data visualization, which are not typically available in traditional physical activity interventions. This app-based approach allows for continuous health data collection and personalized interventions, making it a novel tool for increasing physical activity. ^{11 12 13 14 15}

What is the purpose of this trial?

The goal of this research is to examine the addition of a digitally delivered social support training approach to an existing digital program designed to promote a physically active lifestyle among self-selected teams of adults who are not meeting physical activity guidelines. The main aims are to: 1. Determine if the social support training intervention promotes significantly greater changes in moderate-to-vigorous intensity aerobic physical activity (such as a brisk walk) as measured by an accelerometer (research grade physical activity measurement device) at 3 months compared to the same intervention without social support training among self-selected teams of adults who are not meeting the physical activity guidelines. 2. Determine if the social support training intervention promotes significantly greater changes in social support, motivation, accountability, and autonomy social support (free from excessive control and encouraging one's free will) at 3 months and 12 months compared to the same intervention without social support training. 3. Determine if the social support training intervention promotes significantly greater changes in moderate-to-vigorous intensity aerobic physical activity as measured by an accelerometer at 12 months compared to the same intervention without social support training. 4. Explore whether social support mediates increased and sustained moderate-to-vigorous intensity aerobic physical activity among the entire sample of participants.

Research Team

Courtney Monroe, PhD

Principal Investigator

University of South Carolina

Eligibility Criteria

This trial is for adults who aren't getting enough exercise according to physical activity guidelines. Participants will be part of self-selected teams and must have access to a smartphone. There are no specific exclusion criteria provided, but typically participants with health conditions that prevent safe engagement in physical activities might not qualify.

Inclusion Criteria

Participants must have access to a smartphone (Android or iPhone operating system-based) with an internet connection

Participants must be insufficiently physically active (less than 150 minutes per week of moderate-intensity equivalent aerobic physical activity as measured by waist-worn accelerometer)

Participants must be able to provide informed consent

Exclusion Criteria

Participants who are pregnant, breastfeeding, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation

Participants participating in another physical activity study or program

Participants who report conditions that in the judgment of the Principal Investigator would render them unlikely to be able to independently follow the intervention protocol for 3 months, including conditions which might compromise their ability to engage independently with the intervention website materials and wearable physical activity tracker, as well as complete online questionnaires and adhere to wearing an accelerometer

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment of physical activity levels and social support using questionnaires and accelerometers

1 week

Treatment

Participants receive a 3-month, technology-delivered physical activity intervention with or without social support training

12 weeks

Weekly electronic feedback

Follow-up

Participants are monitored for changes in physical activity and social support at 3 and 12 months

9 months

Treatment Details

Interventions

• Mobile STRIDES app

Trial Overview The study tests a mobile app called Mobile STRIDES with different features: psychoeducation, self-regulation, and social support training. It aims to see if the social support feature helps increase moderate-to-vigorous physical activity (like brisk walking) more than the other features over 3 and 12 months.

Participant Groups

Group I: Team+Training Program Experimental Treatment 3 Interventions

Teams randomized to this arm will receive the same intervention as the Team study arm, as well as digitally delivered social support training.

Group II: Team Program Active Control 2 Interventions

Teams randomized to this arm will be provided with personal physical activity goals focused on moderate-to-vigorous intensity aerobic physical activity minutes and steps. They will also be provided with a Fitibt wearable smartwatch for self-monitoring physical activity, receive weekly electronic feedback for the first month of the intervention about their physical activity progress, and have access to a mobile-compatible study web app containing behavior change content and physical activity progress information.

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials

233

Recruited

122,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

A systematic review of 35 studies involving 7454 participants found that mobile app and tracker interventions led to a small-to-moderate increase in physical activity, equating to an average of 1850 additional steps per day.

Interventions that included text messaging and personalized features were particularly effective, suggesting that these elements enhance user engagement and activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do smartphone applications and activity trackers increase physical activity in adults? Systematic review, meta-analysis and metaregression. Laranjo, L., Ding, D., Heleno, B., et al.[2021]

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]

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]

The ADVANCE study aims to evaluate how adverse events (AEs) are reported in exercise oncology trials, which is crucial for assessing the safety of exercise interventions for cancer patients.

By reviewing published trials and using a standardized checklist for reporting AEs, the study seeks to identify gaps in current practices and inform future research on improving the consistency and transparency of AE reporting in this field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. Luo, H., Schumacher, O., Galvão, DA., et al.[2022]

In a randomized controlled trial involving 209 elderly participants (average age 80), a home-based exercise program was found to be generally safe, with 151 adverse events reported, affecting 47% of participants.

Despite the program's safety, 14% of the adverse events were serious, highlighting that high levels of pre-existing morbidity in this population can pose challenges to maintaining consistent exercise participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices. Hinrichs, T., Bücker, B., Wilm, S., et al.[2015]

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]

The iPedometer application for iPhone was found to be inaccurate in counting steps compared to a reliable StepWatch 3 Step Activity Monitor and a tally counter, especially at various walking speeds.

Out of all tested conditions, the iPedometer only showed a positive correlation in step counting when used on the arm at the slowest speed, indicating it is not a valid tool for monitoring physical activity during treadmill walking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there a valid app for that? Validity of a free pedometer iPhone application. Bergman, RJ., Spellman, JW., Hall, ME., et al.[2022]

References

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

Wearable Technology and Physical Activity Behavior Change in Adults With Chronic Cardiometabolic Disease: A Systematic Review and Meta-Analysis. [2020]

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

Feasibility and acceptability of remotely monitored pedometer-guided physical activity. [2019]

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

Do smartphone applications and activity trackers increase physical activity in adults? Systematic review, meta-analysis and metaregression. [2021]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Pilot study of a cell phone-based exercise persistence intervention post-rehabilitation for COPD. [2021]

5. England pubmed.ncbi.nlm.nih.gov

App-based supplemental exercise in rehabilitation, adherence, and effect on outcomes: a randomized controlled trial. [2022]

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

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

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

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

8. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. [2022]

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

Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices. [2015]

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

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

11. Canada pubmed.ncbi.nlm.nih.gov

Use Patterns of Smartphone Apps and Wearable Devices Supporting Physical Activity and Exercise: Large-Scale Cross-Sectional Survey. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Smartphones and tooth brushing: content analysis of the current available mobile health apps for motivation and training. [2022]

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

The Effects and Patterns among Mobile Health, Social Determinants, and Physical Activity: A Nationally Representative Cross-Sectional Study. [2021]

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

Is there a valid app for that? Validity of a free pedometer iPhone application. [2022]

15. Switzerland pubmed.ncbi.nlm.nih.gov

Experience and Satisfaction with a Family-Based Physical Activity Intervention Using Activity Trackers and Apps: A Qualitative Study. [2023]