- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02670369
Investigating Sedentary Time in Aging: New Directions (ISTAND)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
To date, no one has tested whether the prompting features of commercially available wrist-worn devices (e.g., Jawbone Up) improve breaks from sitting. Single case designs are a cost-effective way to conduct a controlled, randomized study that can inform larger intervention trials. Because the investigators are interested in ascertaining the effect of a very specific intervention on a very specific/single outcome, this study is well-suited to this approach.
The investigators will conduct iterative single case experimental studies using randomization tests. This design can help evaluate technologies for behavior change. To increase statistical power, the investigators opted to conduct an ABA study design (also termed a reversal design) where A is baseline and B is an intervention. Using randomization tests, the length of each A and B phase are determined to vary randomly in length prior to the beginning of each participant's experiment. The investigators will constrain the total time of each A and B phase to last a minimum of 5 days to provide adequate exposure to the A (measurement only) and B (intervention) conditions. The maximum total number of days participants will be enrolled is 28.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Washington
-
Seattle, Washington, Forente stater, 98101
- Group Health Research Institute
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Male or female
- BMI of 25+
- Ages 60+
- Continuously enrolled at Group Health for previous 12 months
- No record of death
- Not on the No Contact list
- Speaks, reads, and writes English
- Able to hold a conversation by phone (no hearing or other limitations)
- Self-reported ability to stand
- Self-reported ability to walk one block unassisted
- No history of an injury from a fall in past 3 months
- Work or retirement situations allows for taking breaks from sitting throughout the day
- Available for the study duration
- No unusual activities planned (e.g. travel, moving) during the study period
- Able to come to Group Health Capitol Hill/Central for measurement visits
- Willing to wear activity monitor (activPAL)
- Self-reports taking less than 4 breaks from sitting during an average hour
- Self-reports sitting more than 7 hours per day
Exclusion Criteria:
- Resides in long-term care, hospice care, or skilled nursing facility (previous 12 months)
- Wheelchair bound
- Diagnosis of dementia, serious mental health disorder, or substance use disorder (previous 24 months)
- Use of an assistive device
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Sitting time prompt
All participants will receive a prompting device (one-arm intervention).
|
Participants will receive a device that prompts them to take breaks from sitting approximately every 15-20 minutes.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Sit-to-stand transitions
Tidsramme: up to 28 days
|
Number of activPAL-measured sit-to-stand transitions measured at the day level
|
up to 28 days
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Dori E Rosenberg, PhD, MPH, Group Health Research Institute
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 5 K23 HL119352-1
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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