Smart Walk App for Physical Activity

Overseen By Rodney P Joseph, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Arizona State University

Disqualifiers: High blood pressure, Pregnancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone app designed to increase physical activity and reduce the risk of heart disease and type 2 diabetes in African American women. Participants will either use the Smart Walk app, which provides a culturally tailored exercise program, or receive a Fitbit activity monitor for comparison. Ideal candidates are African American women who are not very active and have a BMI over 30. Participants should own a smartphone capable of downloading apps and receiving texts. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important health advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Smart Walk app, a smartphone program designed for various cultures, is generally safe for users. The app encourages increased activity, and past studies have not identified any serious issues from its use. Although minor injuries can occur with exercise programs, no major safety concerns have been reported for the Smart Walk app. This indicates that most people use the app without problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Smart Walk app because it offers a culturally tailored approach to boosting physical activity, a unique feature not commonly seen in standard options like gym memberships or generic fitness apps. This tailored intervention is delivered conveniently via smartphone, making it accessible and easy to integrate into daily life. Additionally, the Smart Walk app's personalization aspect addresses the diverse needs of participants, potentially leading to higher engagement and better outcomes compared to traditional fitness trackers like the Fitbit Inspire 3, which provides general activity monitoring without cultural customization.

What evidence suggests that this trial's treatments could be effective for increasing physical activity and reducing risk for heart disease and type 2 diabetes?

This trial will compare the Smart Walk app with a Fitbit Inspire 3 activity monitor. Research has shown that the Smart Walk app helps African American women become more active and lower their risk of heart disease and type 2 diabetes. In a previous study, women using Smart Walk were more active over 8 months. The app is specially designed to meet the needs and preferences of its users, which may enhance its effectiveness. It operates on the principle that people can change their habits by engaging with the app. Early results suggest that this personalized approach can lead to healthier lifestyle choices and possibly reduce health risks. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Smart Walk

Trial Overview 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.

How Is the Trial Designed?

Group I: Smart Walk Experimental Treatment 1 Intervention

Participants will receive a culturally tailored smartphone-delivered physical activity intervention.

Group II: Fitbit Active Control 1 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

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

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]

The Digi-Walker step counter effectively measures physical activity, with a study of 31 adults showing that step counts vary significantly based on pace and individual characteristics like height and body fatness.

Participants averaged 11,603 steps per day when including vigorous activity, suggesting that while pedometers are useful for tracking steps, establishing universal step count guidelines is challenging due to individual variability in activity patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The utility of the Digi-walker step counter to assess daily physical activity patterns. Welk, GJ., Differding, JA., Thompson, RW., 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 study evaluated 4 DASH (Dietary Approaches to Stop Hypertension) apps, finding that only one paid app scored high in quality, while the free apps generally had lower quality ratings.

The research highlights the need for better development of free DASH apps, as the current options may not effectively support users in managing hypertension through diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Apps for the Dietary Approaches to Stop Hypertension (DASH): App Quality Evaluation. DiFilippo, KN., Huang, WD., Chapman-Novakofski, KM.[2020]

A new mHealth application designed to promote physical activity was developed based on seven key characteristics identified from a review of existing technologies, and it was successfully deployed over a 4-week period with 14 participants.

Participants reported high usability scores (average 4.52 out of 5) and used the app for an impressive total of 119,380 minutes, averaging about 7.57 hours per day, indicating strong engagement and satisfaction with the application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Persuasive and Social mHealth Application for Physical Activity: A Usability and Feasibility Study. Al Ayubi, SU., Parmanto, B., Branch, R., et al.[2021]

A systematic evaluation of seven DASH diet apps revealed that only two apps, NOOM and DASH To TEN, met both quality and data security standards, making them suitable for supporting self-management of the DASH diet.

While three apps scored high in quality across various domains, most apps exhibited significant shortcomings in quality and data privacy, highlighting the need for better app development in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Alnooh, G., Alessa, T., Noorwali, E., et al.[2023]

A study involving 78 hospitalized patients showed that using the Hospital Fit app alongside usual physiotherapy led to a trend of increased physical activity, particularly in standing and walking, although the results were not statistically significant.

Patients who used the app for longer periods experienced greater increases in physical activity, suggesting that the app may be beneficial for functionally independent patients in promoting movement during hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of a Smartphone App with an Accelerometer on the Physical Activity Behavior of Hospitalized Patients: A Randomized Controlled Trial. Dijk-Huisman, HCV., Senden, R., Smeets, MHH., et al.[2023]

Interventions using activity trackers during and after inpatient care can significantly increase physical activity levels in patients, with a small positive effect size (SMD = 0.34) observed in 13 studies involving 1435 patients.

However, these increases in physical activity did not lead to significant improvements in physical functioning, indicating that while activity trackers can motivate patients to move more, they may not directly enhance overall physical capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of physical activity interventions using activity trackers during or after inpatient care: a systematic review and meta-analysis of randomized controlled trials. de Leeuwerk, ME., Bor, P., van der Ploeg, HP., et al.[2022]

Interventions using wearable activity trackers during hospitalization significantly increased overall physical activity levels and reduced sedentary behavior among 1911 participants across various medical conditions, showing a standardized mean difference of 0.35 for activity and a reduction of 35.46 minutes per day in sedentary time.

Patients using these trackers also experienced improvements in physical function, with a standardized mean difference of 0.27, indicating that these devices can enhance recovery during hospital stays, although they did not significantly affect pain, mental health, length of stay, or readmission rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions Using Wearable Activity Trackers to Improve Patient Physical Activity and Other Outcomes in Adults Who Are Hospitalized: A Systematic Review and Meta-analysis. Szeto, K., Arnold, J., Singh, B., et al.[2023]

The Hospital Fit smartphone app significantly increased the time hospitalized patients spent standing and walking by an average of 28.43 minutes on postoperative day one, compared to standard physiotherapy alone.

Patients using Hospital Fit had 3.08 times higher odds of achieving functional recovery on postoperative day one, indicating that digital health tools can effectively enhance physical activity and recovery in hospitalized patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone App with an Accelerometer Enhances Patients' Physical Activity Following Elective Orthopedic Surgery: A Pilot Study. van Dijk-Huisman, HC., Weemaes, ATR., Boymans, TAEJ., et al.[2021]

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]

In a 6-month pilot study involving 55 healthy young adults, participants in the overweight-obese group experienced a short-term decrease in BMI but did not maintain this change, indicating challenges in sustaining weight loss and negative feelings associated with social comparison on the app.

Conversely, participants in the underweight-normal BMI group actively engaged with the app's self-monitoring and social features, leading to a significant increase in their daily step count, highlighting the need for personalized interventions to cater to different user experiences and motivations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile Social Networking App for Weight Management and Physical Activity Promotion: Results From an Experimental Mixed Methods Study. Laranjo, L., Quiroz, JC., Tong, HL., et al.[2021]

A systematic review of 27 studies found that health and fitness apps can lead to significant improvements in diet, physical activity, and sedentary behavior, particularly in adults, with 17 out of 23 adult-targeted studies showing positive health outcomes.

Multi-component interventions that include apps were more effective than stand-alone app interventions, suggesting that combining app features with other strategies may enhance user engagement and health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of interventions that use apps to improve diet, physical activity and sedentary behaviour: a systematic review. Schoeppe, S., Alley, S., Van Lippevelde, W., et al.[2022]

This systematic review aims to identify the barriers and facilitators that adults face when using mobile apps and wearable technology to monitor their physical activity and sedentary behaviors, which could help improve health outcomes.

The review will analyze qualitative studies published since 2012, providing insights that can guide the development and implementation of these technologies for better user engagement and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apps and wearables for monitoring physical activity and sedentary behaviour: A qualitative systematic review protocol on barriers and facilitators. Wilde, LJ., Ward, G., Sewell, L., et al.[2022]

A goal-directed movement intervention using a movement sensor significantly increased the daily physical activity of hospitalized patients from an average of 38 minutes to 50 minutes, indicating its effectiveness in promoting movement during hospitalization.

Patients reported a decrease in perceived difficulty to move, suggesting that the intervention not only increased activity levels but also improved patients' confidence in their ability to move.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving physical activity in hospitalized patients: The preliminary effectiveness of a goal-directed movement intervention. van Grootel, J., Bor, P., Netjes, JA., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36673756/

Smart Walk: A Culturally Tailored Smartphone-Delivered ... This article reports the results of Smart Walk: a randomized pilot trial of an 8-month culturally tailored, smartphone-delivered physical ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06337708

Smart Walk: A Culturally Tailored Smartphone-Delivered ... The purpose of this study is to test a culturally tailored, smartphone-delivered intervention designed to increase physical activity and reduce risk for heart ...

3. mdpi.com mdpi.com/1660-4601/20/2/1000

Smart Walk: A Culturally Tailored Smartphone-Delivered ... This article reports the results of Smart Walk: a randomized pilot trial of an 8-month culturally tailored, smartphone-delivered physical activity (PA) ...

4. mhealth.jmir.org mhealth.jmir.org/2020/3/e15346

Development and Initial Usability Tests of Smart Walk Smart Walk is a culturally relevant, social cognitive theory–based, smartphone-delivered intervention designed to increase physical activity (PA) and reduce ...

5. researchgate.net researchgate.net/publication/366940875_Smart_Walk_A_Culturally_Tailored_Smartphone-Delivered_Physical_Activity_Intervention_for_Cardiometabolic_Risk_Reduction_among_African_American_Women

(PDF) Smart Walk: A Culturally Tailored Smartphone ... This article reports the results of Smart Walk: a randomized pilot trial of an 8-month culturally tailored, smartphone-delivered physical ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8103296/

Results of a Culturally Tailored Smartphone-Delivered ... Smart Walk is a culturally tailored, SCT—based 4-month PA intervention delivered through the Smart Walk smartphone app and text messages. The behavioral PA goal ...

7. withpower.com withpower.com/trial/phase-2-heart-diseases-2024-6b88a

Smart Walk App for Physical Activity Research on physical activity interventions, like those involving apps, shows that while minor injuries can occur, no serious adverse events have been reported.