- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07674459
Effects of a Smartphone-Supported Daily Walking Intervention on Psychological Well-Being and Body Composition in Adults With Cardiometabolic Disease (DAILY-WALK)
June 23, 2026 updated by: Daiva Majauskiene, Klaipėda University
Psychological Benefits of Increased Daily Walking Precede Meaningful Changes in BodyComposition in Adults With Cardiometabolic Disease
This study evaluated whether a three-month smartphone-supported daily walking intervention could improve physical activity, psychological well-being, and body composition in adults with cardiometabolic disease.
Participants had cardiovascular disease and/or type 2 diabetes and used the Walk15 smartphone platform to monitor daily step count.
The intervention aimed to increase daily walking by approximately 1,000 steps per day through individualized step goals, self-monitoring, and digital feedback.
Outcomes were assessed before and after the intervention and included daily step count, body composition, handgrip strength, sleep duration, eating behaviors, subjective well-being, vigor, stress, anxiety, health, and happiness.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This was a three-month quasi-experimental longitudinal study in adults aged 20 to 65 years with physician-confirmed cardiovascular disease and/or type 2 diabetes mellitus.
The intervention was delivered through the Walk15 smartphone platform.
Participants received individualized step goals based on baseline activity levels and were encouraged to increase daily walking gradually, aiming for approximately 1,000 additional steps per day.
Daily step counts were monitored through smartphone-connected wearable devices and synchronized with the Walk15 platform.
No dietary modifications, weight-loss program, or structured exercise training were prescribed.
The study assessed changes in physical activity, psychological well-being, lifestyle behaviors, muscle strength, and body composition from baseline to the end of the three-month intervention.
Study Type
Interventional
Enrollment (Actual)
419
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Klaipėda, Lithuania
- Klaipėda University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adults aged 20 to 65 years Physician-confirmed diagnosis of cardiovascular disease and/or type 2 diabetes mellitus verified through medical records Medical clearance from the treating physician confirming that participation in a walking-based physical activity program was safe and appropriate Ability to use the Walk15 smartphone platform or smartphone-connected wearable device for step-count monitoring Written informed consent provided before enrollment
Exclusion Criteria:
- Severe mobility limitations Acute medical conditions Psychiatric disorders requiring pharmacological treatment Inability to complete baseline or post-intervention assessments
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Smartphone-Supported Daily Walking Intervention Arm Type
Participants received a three-month smartphone-supported walking intervention delivered through the Walk15 platform.
Individualized step goals were established based on baseline activity levels, and participants were encouraged to increase daily walking by approximately 1,000 steps per day.
Daily step counts were monitored using smartphone-connected wearable devices and synchronized with the Walk15 platform.
|
Participants received a three-month smartphone-supported walking intervention delivered through the Walk15 platform.
Individualized step goals were established based on baseline daily step counts.
Participants were encouraged to increase daily walking by approximately 1,000 steps per day, progressing gradually during the first month.
Daily step counts were monitored using smartphone-connected wearable devices and synchronized with the Walk15 platform.
Participants received feedback through the platform to support adherence.
No dietary modifications, weight-loss program, or structured exercise training were prescribed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Daily Step Count
Time Frame: Baseline to 3 months
|
Daily step count was assessed using the Walk15 smartphone platform, which synchronized step-count data from participants' smartphones and wearable devices.
Change was calculated as the difference between baseline daily step count and post-intervention daily step count.
|
Baseline to 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Albertas Skurvydas, dr, KU
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 18, 2024
Primary Completion (Actual)
June 18, 2024
Study Completion (Actual)
June 18, 2024
Study Registration Dates
First Submitted
June 23, 2026
First Submitted That Met QC Criteria
June 23, 2026
First Posted (Actual)
June 29, 2026
Study Record Updates
Last Update Posted (Actual)
June 29, 2026
Last Update Submitted That Met QC Criteria
June 23, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KU-Walk15
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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