- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07674459
Effects of a Smartphone-Supported Daily Walking Intervention on Psychological Well-Being and Body Composition in Adults With Cardiometabolic Disease (DAILY-WALK)
23. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
419
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
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Klaipėda, Litauen
- Klaipėda University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Daily Step Count
Tidsramme: 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.
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Baseline to 3 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studiestol: Albertas Skurvydas, dr, KU
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
18. mars 2024
Primær fullføring (Faktiske)
18. juni 2024
Studiet fullført (Faktiske)
18. juni 2024
Datoer for studieregistrering
Først innsendt
23. juni 2026
Først innsendt som oppfylte QC-kriteriene
23. juni 2026
Først lagt ut (Faktiske)
29. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KU-Walk15
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