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Tailored Multicomponent Intervention for Remote Physical Activity Promotion in Inactive Adults

25 juni 2019 bijgewerkt door: Xenia Fischer, University of Basel
The purpose of this study is to compare different modalities to communicate a remote and individually tailored physical activity promotion program.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

288

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Birsstr. 320B
      • Basel, Birsstr. 320B, Zwitserland, 4052
        • University of Basel, Department of Sport, Exercise and Health

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

20 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

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: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: "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.
Experimenteel: "Phone and SMS" group
see intervention description
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.
Actieve vergelijker: "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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Self-reported physical activity level of one week
Tijdsspanne: 6 months of intervention
Simple Physical Activity Questionnaire; SIMPAQ
6 months of intervention
Objectively assessed physical activity level of one week
Tijdsspanne: 6 months of intervention
Accelerometer
6 months of intervention

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Self-reported physical activity level of one week
Tijdsspanne: 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
Tijdsspanne: In the follow-up after 12 months
Accelerometer
In the follow-up after 12 months
body weight
Tijdsspanne: At baseline, 6 months and in the follow-up after 12 months
At baseline, 6 months and in the follow-up after 12 months
health related quality of life (questionnaire)
Tijdsspanne: At baseline, 6 months and in the follow-up after 12 months
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.
At baseline, 6 months and in the follow-up after 12 months
stress-related exhaustion symptoms (questionnaire)
Tijdsspanne: At baseline, 6 months and in the follow-up after 12 months
Perceived stress-related exhaustion symptoms will be measured by the validated Shirom-Melamed Burnout Measure (SMBM) (Shirom & Melamed, 2006).
At baseline, 6 months and in the follow-up after 12 months
Adherence to the PA promotion program (count data)
Tijdsspanne: At baseline, 6 months and in the follow-up after 12 months
Adherence will be calculated by the frequency of logins to the personal profile and the frequency of entering self-monitoring data.
At baseline, 6 months and in the follow-up after 12 months
Satisfaction with the program (questionnaire)
Tijdsspanne: At baseline, 6 months and in the follow-up after 12 months
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.
At baseline, 6 months and in the follow-up after 12 months
Intention on physical activity participation (questionnaire)
Tijdsspanne: At baseline, 6 months and in the follow-up after 12 months
Motivational readiness will be assessed according to the stages of change of the Transtheoretical Model (Fuchs, 2007; Marcus, Rakowski, & Rossi, 1992).
At baseline, 6 months and in the follow-up after 12 months
Outcome expectations on physical activity participation (questionnaire)
Tijdsspanne: At baseline, 6 months and in the follow-up after 12 months
Outcome expectancies regarding the physical activity will be assessed with eight items according to Fuchs (1994).
At baseline, 6 months and in the follow-up after 12 months
Self-efficacy concerning physical activity participation (questionnaire)
Tijdsspanne: At baseline, 6 months and in the follow-up after 12 months
Consistent with Fuchs (2008), self-efficacy will be assess by the confidence to begin, to maintain and to restart regular physical activity.
At baseline, 6 months and in the follow-up after 12 months
Barriers concerning physical activity participation (questionnaire)
Tijdsspanne: At baseline, 6 months and in the follow-up after 12 months
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)
At baseline, 6 months and in the follow-up after 12 months
Social support for physical activity participation (questionnaire)
Tijdsspanne: At baseline, 6 months and in the follow-up after 12 months
Social support will be assessed by 7 items that rate the confidence for support of the social environment (Fuchs, 1997).
At baseline, 6 months and in the follow-up after 12 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Studie directeur: Lukas Zahner, Prof. Dr., Department of Sport, Exercise and Health

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 augustus 2016

Primaire voltooiing (Werkelijk)

1 april 2019

Studie voltooiing (Werkelijk)

1 april 2019

Studieregistratiedata

Eerst ingediend

23 september 2016

Eerst ingediend dat voldeed aan de QC-criteria

28 september 2016

Eerst geplaatst (Schatting)

29 september 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 juni 2019

Laatste update ingediend die voldeed aan QC-criteria

25 juni 2019

Laatst geverifieerd

1 juni 2019

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 2016-00560

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

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Klinische onderzoeken op "Phone" group

3
Abonneren