Fjärrträningsprogram för män på landsbygden
Utvärdering av ett distanslevererat motionsprogram för inaktiva män i landsbygdssamhällen: En genomförbarhetsstudie
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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
South Carolina
-
Columbia, South Carolina, Förenta staterna, 29208
- University of South Carolina
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
|
Övrig: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Feasibility of recruitment
Tidsram: 12 weeks
|
Percentage of recruitment rate (screened/enrolled) |
12 weeks
|
|
Retention
Tidsram: 12 weeks
|
Percentage of participants who complete the study |
12 weeks
|
|
Adherence to coaching calls
Tidsram: 12 weeks
|
Percentage of coaching calls completed in Immediate condition |
12 weeks
|
|
Adherence to self-monitoring
Tidsram: 12 weeks
|
Percentage of self-monitoring logs submitted in Immediate condition |
12 weeks
|
|
Acceptability
Tidsram: 12 weeks
|
Program satisfaction with the 12 week remote program in Immediate condition |
12 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Physical activity - Moderate to vigorous minutes/week
Tidsram: baseline to 12 weeks
|
Moderate-vigorous intensity physical activity (minutes/week) assessed by activPAL |
baseline to 12 weeks
|
|
Physical activity - Steps
Tidsram: baseline to 12 weeks
|
Steps/day assessed by activPAL |
baseline to 12 weeks
|
|
Global Health
Tidsram: baseline to 12 weeks
|
Global Health assessed via PROMIS (t-score) |
baseline to 12 weeks
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Christine A Pellegrini, PhD, University of South Carolina
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STUDY00000136
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
IPD will be shared on request to the PI
Tidsram för IPD-delning
IPD will be available on request after outcomes have been published
Kriterier för IPD Sharing Access
IPD will be available on request after outcomes have been published
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- ICF
Läkemedels- och apparatinformation, studiedokument
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