Fjernbetjenet motionsprogram for landdistrikternes mænd
Evaluering af et fjernleveret motionsprogram for inaktive mænd i landområder: En gennemførlighedsundersøgelse
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.
Studieoversigt
Status
Betingelser
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
South Carolina
-
Columbia, South Carolina, Forenede Stater, 29208
- University of South Carolina
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
|
Andet: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Christine A Pellegrini, PhD, University of South Carolina
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STUDY00000136
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (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
IPD-delingsadgangskriterier
IPD will be available on request after outcomes have been published
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- ICF
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