Fjernstyrt treningsprogram for menn på landsbygda
Evaluering av et fjernlevert fysisk aktivitetsprogram for inaktive menn i landlige samfunn: En gjennomførbarhetsstudie
The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a remote physical activity intervention designed for rural inactive men.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
The proposed study is a pilot randomized controlled trial that will randomize participants to either 1) Immediate intervention, which consists of a 12-week physical activity program or 2) Delayed Intervention, which participants will be assigned to a 6-week abridged version of the program at the end of 12 weeks. Both versions of the physical activity program will provide participants a platform to report their exercise weekly, behavioral lessons, and receive personalized feedback on activity levels. The primary endpoint is to examine the feasibility and acceptability of the 12-week program by evaluating recruitment and retention rates, completion of phone calls, adherence to physical activity self-monitoring, and program satisfaction at 12-weeks. Preliminary efficacy will be assessed by changes in moderate-vigorous physical activity (MVPA), steps/day, health-related quality of life, self-efficacy, self-regulation, and supportive accountability at the end of 12-weeks.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
South Carolina
-
Columbia, South Carolina, Forente stater, 29208
- University of South Carolina
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Identify biological sex as male
- Engage in less than 90 minutes of self-reported moderate intensity exercise
- Ability to read and write in English
- Primarily living in a rural jurisdiction defined by 1 of the 7 more widely used definitions of rurality by the United States government
- Ability to walk independently for at least one block
Exclusion Criteria:
- Have a medical condition that could be made worse with a change in physical activity
- Plans to relocate from primary residence within 3 months of signing up for study
- Not willing to wear physical activity monitor for 7 days or complete surveys
- Less than 4 valid days of activity monitor wear time at baseline assessment
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Immediate
Receive intervention immediately after randomization |
Participants will receive a 12 week remotely delivered physical activity program immediately after randomization. Participants will receive bi-weekly calls, behavioral lessons, and bi-weekly behavioral feedback via email. |
|
Annen: Delayed
Start intervention after 12 week assessment |
Participants receive a 6 week remote physical activity program after completing the 12 week assessment. The program includes weekly calls, behavioral lessons, and weekly behavioral feedback via email. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility of recruitment
Tidsramme: 12 weeks
|
Percentage of recruitment rate (screened/enrolled) |
12 weeks
|
|
Retention
Tidsramme: 12 weeks
|
Percentage of participants who complete the study |
12 weeks
|
|
Adherence to coaching calls
Tidsramme: 12 weeks
|
Percentage of coaching calls completed in Immediate condition |
12 weeks
|
|
Adherence to self-monitoring
Tidsramme: 12 weeks
|
Percentage of self-monitoring logs submitted in Immediate condition |
12 weeks
|
|
Acceptability
Tidsramme: 12 weeks
|
Program satisfaction with the 12 week remote program in Immediate condition |
12 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Physical activity - Moderate to vigorous minutes/week
Tidsramme: baseline to 12 weeks
|
Moderate-vigorous intensity physical activity (minutes/week) assessed by activPAL |
baseline to 12 weeks
|
|
Physical activity - Steps
Tidsramme: baseline to 12 weeks
|
Steps/day assessed by activPAL |
baseline to 12 weeks
|
|
Global Health
Tidsramme: baseline to 12 weeks
|
Global Health assessed via PROMIS (t-score) |
baseline to 12 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Christine A Pellegrini, PhD, University of South Carolina
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY00000136
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD will be shared on request to the PI
IPD-delingstidsramme
IPD will be available on request after outcomes have been published
Tilgangskriterier for IPD-deling
IPD will be available on request after outcomes have been published
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- ICF
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