- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03799146
Identifying the Effect and Working Mechanisms of MyPlan 2.0 in Older Adults
A Randomized Controlled Trial to Identify the Effect and the Working Mechanisms of MyPlan 2.0, a Self-regulation-based e- and mHealth Intervention Targeting Physical Activity and Sedentary Behaviour, in Older Adults
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The aim of this study is to investigate whether and how 'MyPlan 2.0' helps older adults to be more physically active or less sedentary. Two groups will be created, an intervention group and a waiting-list control group. Both groups will be tested during three testing waves: pretest, posttest and follow-up test. Only the intervention group will be given acces to 'MyPlan 2.0'.
'MyPlan 2.0' consists of a website and mobile application targeting physical activity and sedentary behaviour. The intervention has a duration of five weeks.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Ghent, Belgien, 9000
- Department of Movement and Sports Sciences
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Have access to internet
- Being computer literate
Exclusion Criteria:
- non Dutch speaking
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Interventionsgruppe
Deltagerne vil modtage e- og mHealth interventionen 'MyPlan 2.0'.
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MyPlan 2.0 består af fem sessioner.
I løbet af disse fem sessioner bruges følgende adfærdsændringsteknikker til at motivere brugerne til at være mere fysisk aktive eller til at sidde mindre: udforske risikoopfattelser og opfattede fordele, udforske social støtte, give feedback, handlingsplanlægning, mestringsplanlægning og overvågning.
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Eksperimentel: Waiting List control group
Participants will not receive the e- and mHealth intervention 'MyPlan 2.0', but will be given access to the intervention after all testing phases.
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Waiting List control group
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Ændring i objektiv total, let og moderat til kraftig fysisk aktivitet (PA)
Tidsramme: Prætest, posttest (6 uger) og opfølgning (6 måneder)
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Ændring i mængden af total, let og moderat til kraftig fysisk aktivitet, målt via accelerometre
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Prætest, posttest (6 uger) og opfølgning (6 måneder)
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Ændring i objektiv stillesiddende adfærd
Tidsramme: Prætest, posttest (6 uger) og opfølgning (6 måneder)
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Ændring i mængden af samlet siddetid, målt via accelerometre
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Prætest, posttest (6 uger) og opfølgning (6 måneder)
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Change in self-reported total, moderate and moderate-to-vigorous physical activity (PA) as well as total work-related, transport-related, household-related and leisure time PA.
Tidsramme: Pretest, posttest (6 weeks) and follow-up (6 months)
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Change in amount of total, light and moderate-to-vigorous PA well as total work-related, transport-related, household-related and leisure time PA will be measured via the International Physical Activity Questionnaire (IPAQ).
The IPAQ measures physical activity in four domains: work, transport, household and leisure time.
Higher scores indicate higher levels of physical activity.
For each scale the minimum value is 0. We will use the method described by Dubuy et al. (2013) to truncate the data.
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Pretest, posttest (6 weeks) and follow-up (6 months)
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Change in self-reported sedentary behaviour
Tidsramme: Pretest, posttest (6 weeks) and follow-up (6 months)
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Change in amount of total sitting time, measured via the LASA sedentary behaviour self-report questionnaire.
The total score is calculated by summing all 10 items.The minimum value is 0 and the maximum value is 24 hours.
However, data will be truncated at 16 hours.
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Pretest, posttest (6 weeks) and follow-up (6 months)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change in self-efficacy
Tidsramme: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)
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Change in amount of self-efficacy to change behaviour, measured via 5 validated items (questionnaire).
These items were created by the involved research groups.
For each item, the scale ranges from 1 to 10.
The average score on the five items will be considered the final score.
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Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)
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Change in outcome expectancies
Tidsramme: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months
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Outcome expectancies regarding the behaviour change, measured via 5 validated items (questionnaire).
These items were created by the involved research groups.
For each item, the scale ranges from 1 to 10.
The average score on the five items will be considered the final score.
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Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months
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Change in risk perception
Tidsramme: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months
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Risk perception about the behaviour, measured via 4 validated items (questionnaire).
These items were created by the involved research groups.
For each item, the scale ranges from 1 to 10.
The average score on the four items will be considered the final score
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Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months
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Change in intention
Tidsramme: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months
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Amount of intention to change the behaviour, measured via 3 validated items (questionnaire).
These items were created by the involved research groups.
For each item, the scale ranges from 1 to 10.
The average score on the three items will be considered the final score.
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Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months
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Change in action planning
Tidsramme: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months
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Amount of action planning for behaviour change, measured via 3 validated items (questionnaire).
These items were created by the involved research groups.
For each item, the scale ranges from 1 to 10.
The average score on the three items will be considered the final score.
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Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months
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Change in coping planning
Tidsramme: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months
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Amount of coping planning for behaviour change, measured via 3 validated items (questionnaire).
These items were created by the involved research groups.
For each item, the scale ranges from 1 to 10.
The average score on the three items will be considered the final score.
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Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Ilse De Bourdeaudhuij, University Ghent
- Ledende efterforsker: Geert Crombez, University Ghent
Publikationer og nyttige links
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
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MyPlan2.0_older_adults_50
Plan for individuelle deltagerdata (IPD)
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