- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03399916
Ecological Momentary Determinants of Sedentary Behavior
TranSITion: Ecological Momentary Determinants of Sedentary Behavior
Studieoversikt
Detaljert beskrivelse
Phase 1: This is an observational study that will utilized Ecological Momentary Assessment, to determine which personal (e.g. fatigue, mood, and stress level), behavioral (e.g. watching TV, working at desk, and eating meals), environmental (e.g. being at home or work, time of the day, and weather) and contextual factors were associated with sedentary behavior. Three EMAs per day will be sent randomly sent to participants on weekdays (Monday to Friday), for four consecutive weeks (total of 20 days). During these days, participants will also wear an activPAL device to objectively measure sedentary behavior. The purpose of the study is to identify the combination of factors most likely to precede and proceed short (<30 min) and long (≥30 min) bouts of sedentary behavior.
Phase 2: A micro-randomized trial will be used to evaluate the efficacy of an email-based prompt to elicit a proximal effect (e.g., a postural response defined as a transition from seated to standing or seated to moving within 5 minutes to interrupt prolonged sitting) compared to a no prompt condition. A secondary aim of this study is to determine whether prompts that encourage standing are more likely to elicit a response than those that encourage moving. An exploratory aim is to examine whether varying the content of the stand or move prompt to include combinations of short term goals and employer approval, influence the magnitude of response.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Arizona
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Phoenix, Arizona, Forente stater, 85004
- Arizona State University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Full-time employees
- Males or females
- Ages 18-65
- Sedentary working habits (as indicated by >7 hrs/day of sedentary time at work in the Sedentary Behavior Questionnaire)
- Willing to engage in the study assessment and intervention for 10 weeks.
Exclusion Criteria:
- Non-ambulatory, pregnant
- Non-English speaking
- Diagnosis of psychiatric problems or taking psychiatric medications
- Medical history that prohibits prolonged standing.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Prompt
An email based prompt was sent- containing either a stand or move message.
Exploratory variations of the prompt were designed to include the addition of a goal e.g., stand for the next 5-minutes, and/or employer support e.g., PTS says "stand for the next 5 minutes".
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Ingen inngripen: No Prompt
Prompt delivery was sequentially randomized to be sent (ST) or not sent (NST) to all participants (probability of 0.5), at eight decision points per day (between 9am and 5pm), to achieve a total of 3200 randomizations across participants (160 per participant).
Therefore 50% of the time, no prompt was sent.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Minutes of sitting behavior (minutes/8h workday)
Tidsramme: 40 days
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Objectively measured minutes of sitting, standardized to an 8h workday.
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40 days
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Minutes of standing behavior (minutes/8h workday)
Tidsramme: 40 days
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Objectively measured minutes of standing, standardized to an 8h workday.
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40 days
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Minutes of light-intensity physical activity (minutes/8h workday)
Tidsramme: 40 days
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Objectively measured minutes of light-intensity physical activity, standardized to an 8h workday.
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40 days
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Minutes of moderate-vigorous physical activity (minutes/8h workday)
Tidsramme: 40 days
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Objectively measured minutes of moderate-vigorous physical activity, standardized to an 8h workday.
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40 days
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Momentary affective state (4-item Likert Scales)
Tidsramme: 20 days
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Affective states will be assessed using an ecological momentary survey based on the Positive and Negative Affect Scale (4-point Likert scale ranging from "not at all" to "extremely") (Range: 1-4) questionnaire.
The ecological momentary assessment questions were designed to assess a range of contextual information (i.e., current office location, posture, social interaction) and physical and emotional feeling states (i.e., calmness, energy, happiness, stress, sadness, pain level, productivity, and willingness to stand/move).
Each of these questions will be evaluated individually andaveraged to evaluate positive (i.e., calmness, energy, happiness) and negative (i.e., sadness and stress) affective states.
An open-source app (Personal Analytic Companion App) will be used to deliver EMA questions randomly throughout a participant's workday.
This will allow us to measure self-reported levels of positive or negative affect.
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20 days
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- STUDY00004349
Plan for individuelle deltakerdata (IPD)
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