- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
419
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Klaipėda, Litauen
- Klaipėda University
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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.
|
Baseline to 3 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Albertas Skurvydas, dr, KU
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
18. marts 2024
Primær færdiggørelse (Faktiske)
18. juni 2024
Studieafslutning (Faktiske)
18. juni 2024
Datoer for studieregistrering
Først indsendt
23. juni 2026
Først indsendt, der opfyldte QC-kriterier
23. juni 2026
Først opslået (Faktiske)
29. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KU-Walk15
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
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