~160 spots leftby Mar 2027

Smart Walk App for Physical Activity

Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Arizona State University
Disqualifiers: High blood pressure, Pregnancy, others
No Placebo Group
Prior Safety Data
Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?The purpose of this study is to test a culturally tailored, smartphone-delivered intervention designed to increase physical activity and reduce risk for heart disease and type 2 diabetes among African American women.
Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Smart Walk App treatment for increasing physical activity?

Research shows that using smartphone apps with accelerometers, like the Smart Walk App, can help increase physical activity in hospitalized patients. Studies found that similar apps led to more time spent standing and walking, and improved recovery after surgery.

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Is the Smart Walk App generally safe for humans?

Research on physical activity interventions, like those involving apps, shows that while minor injuries can occur, no serious adverse events have been reported. It's important to start slowly and gradually increase activity levels to minimize risks.

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How is the Smart Walk App treatment different from other treatments for increasing physical activity?

The Smart Walk App is unique because it uses smartphone technology and social networking to motivate users to walk more, offering a persuasive and interactive approach compared to traditional methods like pedometers or step counters.

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Eligibility Criteria

This trial is for African American women who are looking to increase their physical activity to reduce the risk of heart disease and type 2 diabetes. The details on specific eligibility criteria have not been provided.

Inclusion Criteria

Insufficiently Active (< 60 minutes of moderate-to-vigorous physical activity per week as measured by Exercise Vital Sign Questionnaire)
Ownership of a smartphone with the ability to download applications (i.e., apps)
I am an African American/Black female.
+6 more

Exclusion Criteria

Plans to relocate out of Phoenix area in next 12 months
Self-reported participation in another diet or weight loss study at screening
Pregnant or planning to become pregnant in the next 12 months
+2 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Smart Walk intervention or a Fitbit-only comparison for an active 4-month intervention period

16 weeks
Regular virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment with minimal contact

8 months

Participant Groups

The study is testing a 'Smart Walk' program, which uses a smartphone app along with a Fitbit device to encourage more exercise. It's designed specifically for African American women and aims at improving their health by making them less sedentary.
2Treatment groups
Experimental Treatment
Active Control
Group I: Smart WalkExperimental Treatment1 Intervention
Participants will receive a culturally tailored smartphone-delivered physical activity intervention.
Group II: FitbitActive Control1 Intervention
Participants will receive a Fitbit Inspire 3 activity monitor.

Smart Walk is already approved in United States for the following indications:

🇺🇸 Approved in United States as Smart Walk for:
  • Increasing physical activity
  • Reducing risk for heart disease and type 2 diabetes among African American women

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Arizona State UniversityPhoenix, AZ
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Who Is Running the Clinical Trial?

Arizona State UniversityLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator

References

Improving physical activity in hospitalized patients: The preliminary effectiveness of a goal-directed movement intervention. [2023]To evaluate the preliminary effectiveness of a goal-directed movement intervention using a movement sensor on physical activity of hospitalized patients.
The Effect of a Smartphone App with an Accelerometer on the Physical Activity Behavior of Hospitalized Patients: A Randomized Controlled Trial. [2023]Inactive behavior is common in hospitalized patients. This study investigated the effectiveness of using a smartphone app with an accelerometer (Hospital Fit) in addition to usual care physiotherapy on increasing patients' physical activity (PA) behavior. A randomized controlled trial was performed at Maastricht University Medical Centre. Patients receiving physiotherapy while hospitalized at the department of Pulmonology or Internal Medicine were randomized to usual care physiotherapy or using Hospital Fit additionally. Daily time spent walking, standing, and upright (standing/walking) (min) and daily number of postural transitions were measured with an accelerometer between the first and last treatment. Multiple linear regression analysis was performed to determine the association between PA behavior and Hospital Fit use, corrected for functional independence (mILAS). Seventy-eight patients were included with a median (IQR) age of 63 (56-68) years. Although no significant effects were found, a trend was seen in favor of Hospital Fit. Effects increased with length of use. Corrected for functional independence, Hospital Fit use resulted in an average increase of 27.4 min (95% CI: -2.4-57.3) standing/walking on day five and 29.2 min (95% CI: -6.4-64.7) on day six compared to usual care. Hospital Fit appears valuable in increasing PA in functionally independent patients.
The effectiveness of physical activity interventions using activity trackers during or after inpatient care: a systematic review and meta-analysis of randomized controlled trials. [2022]Promoting physical activity (PA) in patients during and/or after an inpatient stay appears important but challenging. Interventions using activity trackers seem promising to increase PA and enhance recovery of physical functioning.
Interventions Using Wearable Activity Trackers to Improve Patient Physical Activity and Other Outcomes in Adults Who Are Hospitalized: A Systematic Review and Meta-analysis. [2023]Low levels of physical activity during hospitalization are thought to contribute to a range of poor outcomes for patients. Using wearable activity trackers during hospitalization may help improve patient activity, sedentary behavior, and other outcomes.
Smartphone App with an Accelerometer Enhances Patients' Physical Activity Following Elective Orthopedic Surgery: A Pilot Study. [2021]Low physical activity (PA) levels are common in hospitalized patients. Digital health tools could be valuable in preventing the negative effects of inactivity. We therefore developed Hospital Fit; which is a smartphone application with an accelerometer, designed for hospitalized patients. It enables objective activity monitoring and provides patients with insights into their recovery progress and offers a tailored exercise program. The aim of this study was to investigate the potential of Hospital Fit to enhance PA levels and functional recovery following orthopedic surgery. PA was measured with an accelerometer postoperatively until discharge. The control group received standard physiotherapy, while the intervention group used Hospital Fit in addition to physiotherapy. The time spent active and functional recovery (modified Iowa Level of Assistance Scale) on postoperative day one (POD1) were measured. Ninety-seven patients undergoing total knee or hip arthroplasty were recruited. Hospital Fit use, corrected for age, resulted in patients standing and walking on POD1 for an average increase of 28.43 min (95% confidence interval (CI): 5.55-51.32). The odds of achieving functional recovery on POD1, corrected for the American Society of Anesthesiologists classification, were 3.08 times higher (95% CI: 1.14-8.31) with Hospital Fit use. A smartphone app combined with an accelerometer demonstrates the potential to enhance patients' PA levels and functional recovery during hospitalization.
A Mobile Social Networking App for Weight Management and Physical Activity Promotion: Results From an Experimental Mixed Methods Study. [2021]Smartphone apps, fitness trackers, and online social networks have shown promise in weight management and physical activity interventions. However, there are knowledge gaps in identifying the most effective and engaging interventions and intervention features preferred by their users.
Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. [2022]Researchers who conduct physical activity (PA) intervention studies provide an invaluable opportunity to further the prevention science knowledge base for implementing and delivering PA programs. Despite recommendations that screening is important to increase patient safety, the specific screening criteria best suited for different community applications are unknown. To add to the limited knowledge base, we examined the screening procedures and the occurrence of adverse events among more than 5,500 participants from 11 diverse PA interventions participating in a trans-National Institutes of Health (NIH) collaborative known as the Behavior Change Consortium (BCC). Numerous adverse events occur in sedentary, chronically ill, or older populations, although few are attributed to activity/exercise interventions. No serious study-related adverse events (SRAEs) were reported across different screening practices, interventions, and/or populations. Relatively few minor SRAEs were reported (primarily musculoskeletal injuries), emphasizing the need to be aware of potential musculoskeletal sequelae during exercise interventions. One common characteristic of these studies is that they recommended "start low and go slow" strategies, with moderate intensity PA as the goal behavior. Recommendations to reframe the meaning and use of screening criteria to initiate PA in the community are discussed. Although we were unable to conduct generalizable quantitative analyses from our data, the combined experience of the BCC studies provides a unique opportunity to examine PA-related screening and safety issues across diverse populations, settings, and intervention programs.
Identification of the Most Suitable Mobile Apps to Support Dietary Approaches to Stop Hypertension (DASH) Diet Self-Management: Systematic Search of App Stores and Content Analysis. [2023]Smartphone apps might provide an opportunity to support the Dietary Approaches to Stop Hypertension (DASH) diet, a healthy diet designed to help lower blood pressure. This study evaluated DASH diet self-management apps based on their quality, likely effectiveness, and data privacy/security to identify the most suitable app(s). A systematic search and content analysis were conducted of all DASH diet apps available in Google Play and the Apple App Store in the UK in November 2022. Apps were included if they provided DASH diet tracking. A previous systematic literature review found some commercial apps not found in the app store search, and these were also included in this review. Three reviewers used the App Quality Evaluation Tool (AQEL) to assess each app's quality across seven domains: knowledge acquisition, skill development, behaviour change, purpose, functionality, and appropriateness for adults with hypertension. Domains with a score of 8 or higher were considered high-quality. Two reviewers assessed the apps' data privacy and security and then coded Behaviour change techniques (BCTs) linked to the Theoretical Domain Framework (TDF) underpinning the likely effectiveness of the apps. Seven DASH diet apps were assessed, showing the limited availability of apps supporting DASH diet self-management. The AQEL assessment showed that three apps scored higher than eight in most of the AQEL domains. Nineteen BCTs were used across the apps, linked to nine TDF action mechanisms that may support DASH diet self-management behaviours. Four apps met standards for privacy and security. All seven apps with self-monitoring functionality had sufficient theoretical basis to demonstrate likely effectiveness. However, most had significant quality and data security shortcomings. Only two apps, NOOM and DASH To TEN, were found to have both adequate quality and security and were thus deemed suitable to support DASH diet self-management.
Mobile Apps for the Dietary Approaches to Stop Hypertension (DASH): App Quality Evaluation. [2020]To identify the availability and quality of apps supporting Dietary Approaches to Stop Hypertension (DASH) education.
10.United Statespubmed.ncbi.nlm.nih.gov
Apps and wearables for monitoring physical activity and sedentary behaviour: A qualitative systematic review protocol on barriers and facilitators. [2022]Monitoring of physical activity and sedentary behaviours by mobile phone applications (apps) and wearable technology (wearables) may improve these health behaviours. This systematic review aims to synthesise the qualitative literature on the barriers and facilitators of using apps and wearables for monitoring physical activity and/or sedentary behaviour in adults.
Efficacy of interventions that use apps to improve diet, physical activity and sedentary behaviour: a systematic review. [2022]Health and fitness applications (apps) have gained popularity in interventions to improve diet, physical activity and sedentary behaviours but their efficacy is unclear. This systematic review examined the efficacy of interventions that use apps to improve diet, physical activity and sedentary behaviour in children and adults.
A Persuasive and Social mHealth Application for Physical Activity: A Usability and Feasibility Study. [2021]Advances in smartphones and the wide usage of social networking systems offer opportunities for the development of innovative interventions to promote physical activity. To that end, we developed a persuasive and social mHealth application designed to monitor and motivate users to walk more every day.
Do smartphone applications and activity trackers increase physical activity in adults? Systematic review, meta-analysis and metaregression. [2021]To determine the effectiveness of physical activity interventions involving mobile applications (apps) or trackers with automated and continuous self-monitoring and feedback.
14.United Statespubmed.ncbi.nlm.nih.gov
The utility of the Digi-walker step counter to assess daily physical activity patterns. [2022]The Digi-Walker step counter is a promising and cost-effective tool to measure physical activity under free-living conditions. Two specific studies were conducted to evaluate the number of steps required to meet current physical activity guidelines.
15.United Statespubmed.ncbi.nlm.nih.gov
Is there a valid app for that? Validity of a free pedometer iPhone application. [2022]This study examined the validity of a selected free pedometer application (iPedometer; IP) for the iPhone that could be used to assess physical activity.