Physical Activity and Social Support Prompting Via Phone Messaging
2017. március 8. frissítette: Shinyi Wu, University of Southern California
Phone Messaging for Physical Activity and Social Support Prompting Among Low-Income Latino Patients: A Randomized Pilot Study
The objective of this study was to investigate the feasibility, perceived usefulness, and potential effectiveness of a short text or voice message intervention to activate 1) physical activity behavior change among low-income, urban, Latino patients in diabetes management and 2) supportive behaviors by family members or close friends.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Részletes leírás
Despite the promise of phone-based interventions to effectively support diabetes self-management (DSM), little is known about their impact on the outcomes of highly vulnerable populations such as low-income, inner-city, racial/ethnic minorities.
And while phone-based interventions have generally been successful at reaching and engaging adults with diabetes, they have failed to do the same with family members/friends (FF) whom are a promising source of ongoing support for DSM.
The objective of this study was to investigate the feasibility, perceived usefulness, and potential effectiveness of a short text or voice message (ST/VM) intervention to activate 1) physical activity (PA) behavior change among low-income, urban, Latino patients in diabetes management and 2) supportive behaviors by FF.
The investigators conducted a 12-week pilot study in which participants were randomized into one of three study arms: control, phone messaging (PM), and phone messaging plus social support from FF (PM+FF).
Participants were recruited in person from a diabetes management program at a safety-net ambulatory care clinic.
All participants were given a pedometer and walking log for self-monitoring.
Participants in the PM and PM+FF arms received ST/VMs as reminders to review daily step goals and to self-monitor; explaining the benefits of regular PA, importance of regular PA to daily life, and ways to overcome commonly identified barriers to PA; asking participants to report on PA performance; providing feedback based on responses.
Participants in the PM+FF identified a FF to receive ST/VMs with suggested behaviors that are perceived as supportive by individuals making PA behavior changes.
Participants received semi-structured assessments in person at baseline, 6 weeks, and 12 weeks.
Participants were asked about the extent to which the program enhanced the participant's ability to make PA behavior changes.
The primary outcome measures were daily step counts and perceived FF social support.
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
42
Fázis
- Nem alkalmazható
Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
18 év és régebbi (Felnőtt, Idősebb felnőtt)
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Összes
Leírás
Inclusion Criteria:
- Age greater than or equal to 18 years
- Diagnosis of type 2 diabetes
- No medical conditions restricting patient from beginning a walking program
- Preferred language of English or Spanish, self-identifies as a Hispanic
- Ability to walk without the use of assistive devices such as canes or walkers
- Available to attend three interviews at the clinic
- Does not plan to move away from the region or be out of the country during the next three months
- Has a working phone where they can receive regular short text or voice messages for three months
Exclusion Criteria:
- Pregnant or breastfeeding women
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Támogató gondoskodás
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Egyéb: Control
Pedometers and walking logs
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Participants were recommended to use the pedometer and walking log to self-monitor how many steps participants walked each day.
Participants were recommended to gradually increase daily steps over the course of 12 weeks until reaching 10,000 steps per day.
Participants were also recommended to walk at a brisk pace for 3000 of these steps, which roughly translates to 30 minutes per day.
|
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Kísérleti: Phone Messaging
|
Participants were recommended to use the pedometer and walking log to self-monitor how many steps participants walked each day.
Participants were recommended to gradually increase daily steps over the course of 12 weeks until reaching 10,000 steps per day.
Participants were also recommended to walk at a brisk pace for 3000 of these steps, which roughly translates to 30 minutes per day.
Participants received short text or voice messages (depending on participant preference) as reminders to review daily step goals and to self-monitor; explaining the benefits of regular physical activity, importance of regular physical activity to daily life, and ways to overcome commonly identified barriers to physical activity; asking participants to report on their physical activity performance; providing feedback based on responses.
|
|
Kísérleti: Phone Messaging + Family/Friend Support
|
Participants were recommended to use the pedometer and walking log to self-monitor how many steps participants walked each day.
Participants were recommended to gradually increase daily steps over the course of 12 weeks until reaching 10,000 steps per day.
Participants were also recommended to walk at a brisk pace for 3000 of these steps, which roughly translates to 30 minutes per day.
Participants received short text or voice messages (depending on participant preference) as reminders to review daily step goals and to self-monitor; explaining the benefits of regular physical activity, importance of regular physical activity to daily life, and ways to overcome commonly identified barriers to physical activity; asking participants to report on their physical activity performance; providing feedback based on responses.
Participants identified a family member or close friend (FF) to receive short text or voice messages (depending on FF preference) with suggested behaviors that are perceived as supportive by individuals making physical activity behavior changes.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change in average daily steps assessed by pedometers
Időkeret: Baseline, 6 weeks, 12 weeks
|
Change in average daily steps assessed using pedometer 7-day data storage
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Baseline, 6 weeks, 12 weeks
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change in body mass index
Időkeret: Baseline, 6 weeks, 12 weeks
|
Change in Body Mass Index, which was calculated as weight (in kilograms) over height squared (in centimeters)
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Baseline, 6 weeks, 12 weeks
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Change in exercise self-efficacy assessed using the Exercise Self-Efficacy Scale
Időkeret: Baseline, 6 weeks, 12 weeks
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Change in exercise self-efficacy assessed using the Exercise Self-Efficacy Scale
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Baseline, 6 weeks, 12 weeks
|
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Change in barriers self-efficacy assessed using the Barriers Self-Efficacy Scale
Időkeret: Baseline, 6 weeks, 12 weeks
|
Change in barriers self-efficacy assessed using the Barriers Self-Efficacy Scale
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Baseline, 6 weeks, 12 weeks
|
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Change in perceived family/friend social support assessed using the Social Support and Exercise Survey
Időkeret: Baseline, 6 weeks, 12 weeks
|
Change in perceived family/friend social support assessed using the Social Support and Exercise Survey
|
Baseline, 6 weeks, 12 weeks
|
Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change in perceived usefulness assessed using patient interviews
Időkeret: 6 weeks, 12 weeks
|
At the 6- and 12-week follow-up interviews, participants were asked a series of unstructured questions regarding the extent to which the program enhanced a participant's ability to make physical activity behavior changes.
These questions inquired about participants' thoughts on setting PA goals, self-monitoring, educational and feedback ST/VMs, and the idea of using ST/VMs to communicate with patients about PA behavior change.
For participants in the PM+FF arms, the questions also inquired about supportive behaviors exhibited by FF since the start of the program and participants' thoughts on the idea of using ST/VMs to communicate with FF about patients' PA behavior changes.
Investigators also asked if participants would be willing to participate in a similar program in the future and if participants would be willing to recommend the program to other patients.
The latter two were yes/no questions.
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6 weeks, 12 weeks
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Change in perceived usability of pedometers assessed via patient interviews
Időkeret: Baseline, 6 weeks, 12 weeks
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Semi-structured patient interview questions inquiring about the degree to which participants perceived the pedometers to be easy to use
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Baseline, 6 weeks, 12 weeks
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Change in perceived barriers to receipt of and engagement with ST/VMs assessed via patient interviews
Időkeret: 6 weeks, 12 weeks
|
Semi-structured patient interview questions inquiring about participants' perceived barriers to the receipt of and engagement with ST/VMs
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6 weeks, 12 weeks
|
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Change in engagement with ST/VMs requiring a response assessed via call logs
Időkeret: 6 weeks, 12 weeks
|
Percentage of times that participants responded to ST/VMs requiring a response
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6 weeks, 12 weeks
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Change in receipt of ST/VMs assessed via self-report and call logs
Időkeret: 6 weeks, 12 weeks
|
Percentage of short text messages delivered that were received assessed via self-report, and percentage of voice messages that were received assessed via call logs
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6 weeks, 12 weeks
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Change in non-compliance with wearing pedometer assessed via pedometer and walking log
Időkeret: Baseline, 6 weeks, 12 weeks
|
Percentage of patients that did not wear the pedometer for a minimum of three consecutive days for at least 10 hours per day.
This data will be obtained using the pedometer 7-day memory storage and participants' self-reported hours of use.
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Baseline, 6 weeks, 12 weeks
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Recruitment and retention rates assessed via recruitment and follow-up logs
Időkeret: 1 day (Recruitment), 6 weeks, 12 weeks
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Percentage of patients that were screened, were eligible to participate, and enrolled in the study.
Percentage of patients who completed the 6-week and 12-week follow-up assessments.
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1 day (Recruitment), 6 weeks, 12 weeks
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Sufficiency or restrictiveness of eligibility criteria assessed via recruitment logs
Időkeret: 1 day (Recruitment)
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Percentage of patients that were screened, but were ineligible to participate and the reasons why
|
1 day (Recruitment)
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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: Shinyi Wu, Ph.D., University of Southern California
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete
2015. április 1.
Elsődleges befejezés (Tényleges)
2015. november 1.
A tanulmány befejezése (Tényleges)
2015. november 1.
Tanulmányi regisztráció dátumai
Először benyújtva
2016. április 12.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2016. július 29.
Első közzététel (Becslés)
2016. augusztus 1.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2017. március 13.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2017. március 8.
Utolsó ellenőrzés
2017. március 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Egyéb vizsgálati azonosító számok
- HS-13-00471
- 3U54NS081764-03S1 (Az Egyesült Államok NIH támogatása/szerződése)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
ELDÖNTETLEN
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .
Klinikai vizsgálatok a A fizikai aktivitás
-
Northumbria UniversityNewcastle-upon-Tyne Hospitals NHS TrustToborzásFáradtság | A fizikai aktivitás | Önszabályozás | Krónikus állapot | Activity PacingEgyesült Királyság