- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02918578
Tailored Multicomponent Intervention for Remote Physical Activity Promotion in Inactive Adults
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Physical inactivity (PI) adversely affects various non-communicable diseases (WHO, 2010) and has been recently entitled "the biggest public health problem of the 21th century" (Blair, 2009). Despite the strong evidence for physical activity (PA) related health benefits, one third of the world's population is physically inactive (Hallal et al., 2012). In Switzerland, 35% of the adults are not meeting the minimum recommendation of 2.5h moderate to vigorous activity per week (BASPO, 2013). Present PI patters accompanied with demographic changes and the burden of non-communicable diseases (WHO, 2010) constitute a notable challenge to the health-care system. Thus, effective prevention programs that engage individuals to become more physically active are needed and of public interest.
Regarding the application for a wide public, the use of technologies for a remote delivery of PA promotion programs is promising (Castro & King, 2002). Thereby, PA lifestyle interventions including individually tailored program components (Noar, Benac, & Harris, 2007), personal coaching (Foster, Richards, Thorogood, & Hillsdon, 2013), behavior change techniques (BCT) (Michie, Abraham, Whittington, McAteer, & Gupta, 2009) and regular prompting (push notifications) (De Leon, Fuentes, & Cohen, 2014) are regarded as effective means to improve PA behavior. However, it is still not examined to date, which intervention components could be effectively translated into practice. The required density, the most effective modality and long-term outcomes of PA promotion program need to be examined (Foster et al., 2013).
Within this study three versions to communicate an individually tailored PA promotion program will be compared. The program consists of individual counseling but is delivered without face-to-face contact. Exercise recommendations and behavior change techniques will be elaborated on an individual basis, communicated and assessed. The programs content will then be tailored according to personal background information (e.g. goals, preferences) assessed by questionnaires.
A personalized activity-profile on a specifically developed internet portal (on www.movingcall.com) enables safe exchange between participant and coach. The activity-profile includes a weekly activity plan, questionnaires and a diary to document daily PA behavior.
All enrolled participants will have access to a personal activity profile and receive a tailored advice to increase their physical activity levels. Depending on the interventional arm the advice will be delivered in a more supportive and interactive manner. Participants will be randomly assigned to one of the three study arms.
The primary objective is to assess the effect of regular coaching and prompting on PA level. Secondary objectives are the assessment of follow-up effects of PA changes and changes in psychosocial determinants of PA as well as the comparison self-reported and objectively assessed PA data.
Outcome measures will be assessed prior to the start of the intervention, at the end of the six months and in the follow-up period after 12 months.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Birsstr. 320B
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Basel, Birsstr. 320B, Švýcarsko, 4052
- University of Basel, Department of Sport, Exercise and Health
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- not meeting the physical activity guidelines of 150 minutes moderate or 75 minutes vigorous aerobic activity
Exclusion Criteria:
- medical condition that contraindicates the participation in regular moderate-intensity exercise
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: "Phone" group
see intervention description
|
Participants in the "phone" group receive 12 individually tailored coaching sessions (15 - 20 min).
The coaching calls are scheduled biweekly.
Participants receive their tailored advice via interactive counseling.
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Experimentální: "Phone and SMS" group
see intervention description
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The "phone and SMS" group receive the same coaching as the "phone" group.
They additionally receive two tailored SMS per week over the course of six months.
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Aktivní komparátor: "single writing" group
see intervention description
|
The control intervention consists of a "minimal credible" physical activity PA promotion program.
Participants in the control group receive a singular written advice and an activity plan but no counseling by phone.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Self-reported physical activity level of one week
Časové okno: 6 months of intervention
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Simple Physical Activity Questionnaire; SIMPAQ
|
6 months of intervention
|
Objectively assessed physical activity level of one week
Časové okno: 6 months of intervention
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Accelerometer
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6 months of intervention
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Self-reported physical activity level of one week
Časové okno: In the follow-up after 12 months
|
Simple Physical Activity Questionnaire; SIMPAQ
|
In the follow-up after 12 months
|
Objectively assessed physical activity level of one week
Časové okno: In the follow-up after 12 months
|
Accelerometer
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In the follow-up after 12 months
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body weight
Časové okno: At baseline, 6 months and in the follow-up after 12 months
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At baseline, 6 months and in the follow-up after 12 months
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health related quality of life (questionnaire)
Časové okno: At baseline, 6 months and in the follow-up after 12 months
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Health related quality of life will be assessed by the Short Form 12 Questionnaire (SF-12) (Bullinger, 1995; Ware, Kosinski, & Keller, 1996).
The questionnaire includes 12 items on general physical health status and mental health distress.
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At baseline, 6 months and in the follow-up after 12 months
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stress-related exhaustion symptoms (questionnaire)
Časové okno: At baseline, 6 months and in the follow-up after 12 months
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Perceived stress-related exhaustion symptoms will be measured by the validated Shirom-Melamed Burnout Measure (SMBM) (Shirom & Melamed, 2006).
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At baseline, 6 months and in the follow-up after 12 months
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Adherence to the PA promotion program (count data)
Časové okno: At baseline, 6 months and in the follow-up after 12 months
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Adherence will be calculated by the frequency of logins to the personal profile and the frequency of entering self-monitoring data.
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At baseline, 6 months and in the follow-up after 12 months
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Satisfaction with the program (questionnaire)
Časové okno: At baseline, 6 months and in the follow-up after 12 months
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A self-compiled questionnaire will be used to assess general satisfaction, motivation to continue with the program, comprehensibility of the profile and suggestions for future improvements of the program.
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At baseline, 6 months and in the follow-up after 12 months
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Intention on physical activity participation (questionnaire)
Časové okno: At baseline, 6 months and in the follow-up after 12 months
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Motivational readiness will be assessed according to the stages of change of the Transtheoretical Model (Fuchs, 2007; Marcus, Rakowski, & Rossi, 1992).
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At baseline, 6 months and in the follow-up after 12 months
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Outcome expectations on physical activity participation (questionnaire)
Časové okno: At baseline, 6 months and in the follow-up after 12 months
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Outcome expectancies regarding the physical activity will be assessed with eight items according to Fuchs (1994).
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At baseline, 6 months and in the follow-up after 12 months
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Self-efficacy concerning physical activity participation (questionnaire)
Časové okno: At baseline, 6 months and in the follow-up after 12 months
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Consistent with Fuchs (2008), self-efficacy will be assess by the confidence to begin, to maintain and to restart regular physical activity.
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At baseline, 6 months and in the follow-up after 12 months
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Barriers concerning physical activity participation (questionnaire)
Časové okno: At baseline, 6 months and in the follow-up after 12 months
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Perceived barriers: Participants will be presented a list of 19 potential barriers and asked to indicate how strong each one prevented physical activity (Fuchs, Seelig, Gohner, Burton, & Brown, 2012)
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At baseline, 6 months and in the follow-up after 12 months
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Social support for physical activity participation (questionnaire)
Časové okno: At baseline, 6 months and in the follow-up after 12 months
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Social support will be assessed by 7 items that rate the confidence for support of the social environment (Fuchs, 1997).
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At baseline, 6 months and in the follow-up after 12 months
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Lukas Zahner, Prof. Dr., Department of Sport, Exercise and Health
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 2016-00560
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