Physical Activity and Social Support Prompting Via Phone Messaging
8 maart 2017 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
42
Fase
- Niet toepasbaar
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Ander: Control
Pedometers and walking logs
|
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.
|
|
Experimenteel: 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.
|
|
Experimenteel: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in average daily steps assessed by pedometers
Tijdsspanne: Baseline, 6 weeks, 12 weeks
|
Change in average daily steps assessed using pedometer 7-day data storage
|
Baseline, 6 weeks, 12 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in body mass index
Tijdsspanne: Baseline, 6 weeks, 12 weeks
|
Change in Body Mass Index, which was calculated as weight (in kilograms) over height squared (in centimeters)
|
Baseline, 6 weeks, 12 weeks
|
|
Change in exercise self-efficacy assessed using the Exercise Self-Efficacy Scale
Tijdsspanne: Baseline, 6 weeks, 12 weeks
|
Change in exercise self-efficacy assessed using the Exercise Self-Efficacy Scale
|
Baseline, 6 weeks, 12 weeks
|
|
Change in barriers self-efficacy assessed using the Barriers Self-Efficacy Scale
Tijdsspanne: Baseline, 6 weeks, 12 weeks
|
Change in barriers self-efficacy assessed using the Barriers Self-Efficacy Scale
|
Baseline, 6 weeks, 12 weeks
|
|
Change in perceived family/friend social support assessed using the Social Support and Exercise Survey
Tijdsspanne: 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
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in perceived usefulness assessed using patient interviews
Tijdsspanne: 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.
|
6 weeks, 12 weeks
|
|
Change in perceived usability of pedometers assessed via patient interviews
Tijdsspanne: Baseline, 6 weeks, 12 weeks
|
Semi-structured patient interview questions inquiring about the degree to which participants perceived the pedometers to be easy to use
|
Baseline, 6 weeks, 12 weeks
|
|
Change in perceived barriers to receipt of and engagement with ST/VMs assessed via patient interviews
Tijdsspanne: 6 weeks, 12 weeks
|
Semi-structured patient interview questions inquiring about participants' perceived barriers to the receipt of and engagement with ST/VMs
|
6 weeks, 12 weeks
|
|
Change in engagement with ST/VMs requiring a response assessed via call logs
Tijdsspanne: 6 weeks, 12 weeks
|
Percentage of times that participants responded to ST/VMs requiring a response
|
6 weeks, 12 weeks
|
|
Change in receipt of ST/VMs assessed via self-report and call logs
Tijdsspanne: 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
|
6 weeks, 12 weeks
|
|
Change in non-compliance with wearing pedometer assessed via pedometer and walking log
Tijdsspanne: 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.
|
Baseline, 6 weeks, 12 weeks
|
|
Recruitment and retention rates assessed via recruitment and follow-up logs
Tijdsspanne: 1 day (Recruitment), 6 weeks, 12 weeks
|
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.
|
1 day (Recruitment), 6 weeks, 12 weeks
|
|
Sufficiency or restrictiveness of eligibility criteria assessed via recruitment logs
Tijdsspanne: 1 day (Recruitment)
|
Percentage of patients that were screened, but were ineligible to participate and the reasons why
|
1 day (Recruitment)
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Shinyi Wu, Ph.D., University of Southern California
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 april 2015
Primaire voltooiing (Werkelijk)
1 november 2015
Studie voltooiing (Werkelijk)
1 november 2015
Studieregistratiedata
Eerst ingediend
12 april 2016
Eerst ingediend dat voldeed aan de QC-criteria
29 juli 2016
Eerst geplaatst (Schatting)
1 augustus 2016
Updates van studierecords
Laatste update geplaatst (Werkelijk)
13 maart 2017
Laatste update ingediend die voldeed aan QC-criteria
8 maart 2017
Laatst geverifieerd
1 maart 2017
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- HS-13-00471
- 3U54NS081764-03S1 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Pedometers and Walking Logs
-
Rigshospitalet, DenmarkNovo Nordisk A/S; Copenhagen University Hospital at Herlev; Danish Cancer Society; TrygFonden, DenmarkVoltooid