- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01432327
The Impact of Real-time Feedback on Physical Activity Patterns in Flemish Employees
23. februar 2015 opdateret af: Karen Van Hoye, KU Leuven
The Impact of Real-time Feedback on Physical Activity Patterns in Flemish Employees: an Intervention Study
The aim of the study is to assess an increase of daily physical activity from electronic self-monitoring, to compare these values to the 10.000 step program, and to compare with real-time feedback with and without guidance from a Personal Coach.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The purpose of this intervention study is to determine the effectiveness of continuous self-monitoring and real-time feedback from the SenseWear Armband (BodyMedia) alone and in combination with Personal Coaching to enhance physical activity and influence consciousness about its own physical activity patterns over a 12-month period in sedentary Flemish employees.
The investigators hypothesize that the use of the feedback will increase awareness and subsequent physical activity levels of inactive office workers.
Another hypothesizes is that the weekly meeting with a Personal Coach will add a controlling element and therefore employees of the 'coaching group' will have a higher physical activity level at the end of the intervention period compared to the other groups.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
227
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Leuven, Belgien, 3000
- Katholieke Universiteit Leuven - Tervuursevest 101
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 68 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Employee
- Physical Activity Level < 1.71 MET
- Willing to wear the SenseWear Armband for 5-6 weeks
Exclusion Criteria:
- Student
- Senior
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Placebo komparator: Control group
This group receives no kind of feedback during the intervention period.
The participants wear the SenseWear Armband for 4 weeks and results of the intervention are discussed after the 4 week intervention period.
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Participants wear the SenseWear Armband for 4 weeks
Andre navne:
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Eksperimentel: Step Group
This group receives feedback about the daily amount of steps by means of a pedometer.
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Participants receive a pedometer to determine their daily amount of steps.
Every day they write down their amount of steps in a step diary.
Andre navne:
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Eksperimentel: Display Group
Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display
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Participants use the self-monitoring device (display) to aid behavior change via real-time lifestyle feedback targeting physical activity. The display has a versatile design that allows it to be clipped to a shirt, bag or belt loop. The Display can help participants stay in sync with their daily goals.
Andre navne:
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Eksperimentel: Coaching Group
Participants receive real-time feedback on their energy expenditure, step count and minutes of physical activity by means of the SenseWear Display and weekly meet with a Personal Coach to discuss their progress
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A weekly meeting with a Personal Coach to evaluate the physical activity patterns in daily life
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Physical Activity Level
Tidsramme: One year
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To account for differences in body size and composition, the 24-hour energy requirement (kcal/day) is expressed as a multiple of the basal metabolic rate per 24 hours by using the PAL value (PAL = total energy expenditure/basal metabolic rate).
A desirable PAL includes the regular practice of physical activity at work or in spare time with an intensity and duration that will reduce the risk of becoming overweight and developing a variety of non-communicable chronic diseases usually associated as co-morbidities with obesity.
This corresponds to PAL values of 1.75 and higher.
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One year
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Daily Energy Expenditure in Physical Activity
Tidsramme: One year
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Minutes of physical activity.
Activities can be classified as moderate-intensity, vigorous-intensity or very vigorous-intensity activities based upon the amount of energy used by the body while doing the activity.
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One year
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Percent of Participants Losing Fat Percentage
Tidsramme: One Year
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The amount of body fat is measured by bioelectrical impedance analysis (BIA).
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One Year
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Stages of Motivational Readiness for Physical Activity
Tidsramme: One Year
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According to The Stages of Motivational Readiness for Change Model (SOC), individuals move through a series of stages as they adopt and maintain a new habit(Prochaska & DiClemente, 1983).
Specifically, the stages include Precontemplation, Contemplation, Preparation, Action, and Maintenance.The relevant variables were assessed in a self-administered questionnaire.
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One Year
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Step Count
Tidsramme: One Year
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Daily number of steps
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One Year
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Johan Lefevre, Prof Dr., KU Leuven
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2010
Primær færdiggørelse (Faktiske)
1. februar 2015
Studieafslutning (Faktiske)
1. februar 2015
Datoer for studieregistrering
Først indsendt
9. september 2011
Først indsendt, der opfyldte QC-kriterier
9. september 2011
Først opslået (Skøn)
12. september 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
13. marts 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. februar 2015
Sidst verificeret
1. februar 2015
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- KULEUVEN_RTFDB
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .