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Behavioral Intervention

Smart Walk for Heart Disease

Phase 2

Recruiting

Research Sponsored by Arizona State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at 4-months and 12-month

Awards & highlights

Study Summary

This trial aims to test a smartphone app that is customized for African American women to help them be more active and lower their risk of heart disease and type 2 diabetes.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this intervention involves physical activity, potential side effects may include muscle soreness, fatigue, or injury from exercise. However, these are common when starting any new workout routine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at 4-months and 12-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at 4-months and 12-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at 4-months and 12-months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in accelerometer-measured moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months

Change in self-reported moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months

Secondary outcome measures

Change in aortic pulse wave velocity from baseline to 4- and 12-months

Change in behavioral capability for physical activity from baseline to 4- and 12-months

Change in blood pressure (mmHG) from baseline to 4- and 12-months

+16 more

Other outcome measures

Cost-effectiveness

Objectively-measured home neighborhood characteristics

Participant costs

+6 more

Trial Design

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Arizona State UniversityLead Sponsor

283 Previous Clinical Trials

109,274 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,840 Previous Clinical Trials

47,851,884 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Smart Walk received approval from the FDA?

"The safety rating for Smart Walk is 2 as per Power's assessment, denoting a moderate level of safety assurance. This determination aligns with the Phase 2 trial stage where some safety data is available but no efficacy data has been established yet."

Answered by AI

Are there any ongoing efforts to enroll participants for this study at the moment?

"Indeed, information available on clinicaltrials.gov confirms the current patient recruitment status of this trial. The study was initially posted on January 19, 2024, and recently updated on March 25, 2024. It aims to enroll a total of 240 patients at a single site."

Answered by AI

What is the primary objective of conducting this clinical trial?

"The primary focus of this clinical investigation is to evaluate alterations in self-reported moderate-to-vigorous physical activity levels from the beginning to 4- and 12-months. Additionally, secondary endpoints encompass variations in fasting glucose concentrations after a 10-hour fast at baseline, 4-, and 12-month intervals utilizing an automated chemical analyzer. Furthermore, it includes shifts in expectations regarding physical exercise employing Resnick's (2000) Outcome Expectation Scale for Exercise scale that ranges from 1-5. Lastly, modifications in interleukin-15 (IL-15) levels will be assessed using a commercial multiplex immunoassay"

Answered by AI

Can individuals who have surpassed 70 years of age participate in this research?

"Participants eligible for this research study fall within the age range of 24 to 65 years. Notably, there are a substantial number of clinical trials available specifically for individuals under 18 and those over 65 years old, with 341 trials catered towards minors and 1344 studies targeted at older adults."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Smart Walk: A Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women

2024. "Smart Walk: A Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06337708.

All > Gestational Diabetes > Heart Disease