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Completed

NCT Number: NCT07674459

Effects of a Smartphone-Supported Daily Walking Intervention on Psychological Well-Being and Body Composition 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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klaipėda University

Klaipėda, Lithuania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smartphone-Supported Daily Walking

Behavioral

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Klaipėda University

Other

Registry information

Official study title

Psychological Benefits of Increased Daily Walking Precede Meaningful Changes in BodyComposition in Adults With Cardiometabolic Disease

Acronym: DAILY-WALK

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 29, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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