Cardiovascular Disease PreventionDAILY-WALKNCT07674459
Effects of a Smartphone-Supported Daily Walking Intervention on Psychological Well-Being and Body Composition in Adults With Cardiometabolic Disease
A study testing Smartphone-Supported Daily Walking in people with Cardiovascular Disease Prevention, run by Klaipėda University at 1 site in Lithuania.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Cardiovascular Disease Prevention
- What is being tested?
- Smartphone-Supported Daily Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 419 participants
- Where
- 1 siteLithuania
- Study dates
- 18 Mar 2024to 18 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe mobility limitations Acute medical conditions Psychiatric disorders requiring pharmacological treatment Inability to complete baseline or post-intervention assessments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Disease Prevention
- Being tested
- Smartphone-Supported Daily Walking
- Keywords
- Daily walking, Step count, Smartphone application, Physical activity, Body composition, Psychological well-being, Stress, Anxiety
- Medical subject headings
- Motor Activity, Psychological Well-Being, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-Supported Daily WalkingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone-Supported Daily Walking Intervention Arm Type | Experimental | 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. Receives: Behavioral: Smartphone-Supported Daily Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Daily Step Count
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.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start18 Mar 2024
- Primary completion18 Jun 2024
- Study completion18 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Disease PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants were assigned to a single smartphone-supported walking intervention group. There was no randomized control group. Outcomes were assessed before and after the three-month intervention.
- Masking
- None (open label)
- Enrolment
- 419 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klaipėda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daiva Majauskiene, Klaipėda University
- Investigators
- Albertas Skurvydas, dr, Study chair, KU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674459
- Sponsor's protocol ID
- KU-Walk15
- Acronym
- DAILY-WALK
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Benefits of Increased Daily Walking Precede Meaningful Changes in BodyComposition in Adults With Cardiometabolic Disease
- ClinicalTrials.gov ID
- NCT07674459
- Acronym / sponsor ID
- DAILY-WALK / KU-Walk15
- Conditions
- Cardiovascular Disease Prevention
- Keywords
- Daily walking, Step count, Smartphone application, Physical activity, Body composition, Psychological well-being, Stress, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 419 participants (actual)
- Lead sponsor
- Klaipėda UniversityUniversity, hospital or other
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants were assigned to a single smartphone-supported walking intervention group. There was no randomized control group. Outcomes were assessed before and after the three-month intervention.
| Arm | Type | Receives |
|---|---|---|
| Smartphone-Supported Daily Walking Intervention Arm Type | Experimental | Behavioral: Smartphone-Supported Daily WalkingParticipants 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Severe mobility limitations Acute medical conditions Psychiatric disorders requiring pharmacological treatment Inability to complete baseline or post-intervention assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone-Supported Daily WalkingParticipants 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. | Behavioural | Smartphone-Supported Daily Walking Intervention Arm Type |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
Related trials for Cardiovascular Disease Prevention
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Recruiting
Novel Risk Prediction Approaches for the Primary Prevention of Cardiovascular Diseases in Italy: the CVRISK-IT Trial (CVRISK-IT)
Cardiovascular Risk, Genetic Cardiovascular Risk
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albertas Skurvydas, dr study chair
KU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone-Supported Daily Walking in people with Cardiovascular Disease Prevention, run by Klaipėda University at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Daily Step Count (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.