NCT07674459

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
419

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 18, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2024

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2026

Completed
Last Updated

June 29, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

June 23, 2026

Last Update Submit

June 23, 2026

Conditions

Keywords

Daily walkingStep countSmartphone applicationPhysical activityBody compositionPsychological well-beingStressAnxiety

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline to 3 months

Study Arms (1)

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.

Behavioral: Smartphone-Supported Daily Walking

Interventions

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.

Smartphone-Supported Daily Walking Intervention Arm Type

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Severe mobility limitations Acute medical conditions Psychiatric disorders requiring pharmacological treatment Inability to complete baseline or post-intervention assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klaipėda University

Klaipėda, Lithuania

Location

MeSH Terms

Conditions

Motor ActivityPsychological Well-BeingAnxiety Disorders

Condition Hierarchy (Ancestors)

BehaviorPersonal SatisfactionMental Disorders

Study Officials

  • Albertas Skurvydas, dr

    KU

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 23, 2026

First Posted

June 29, 2026

Study Start

March 18, 2024

Primary Completion

June 18, 2024

Study Completion

June 18, 2024

Last Updated

June 29, 2026

Record last verified: 2026-06

Locations