- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01587092
Workstation Pilot Study
WorkStation Pilot Study
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Eligible participants will be randomized by chance to the WorkStation Intervention Group or to a Usual Working Condition Group.
The WorkStation Intervention Group will be asked to walk for up to 1.5 hours per day during the work week of Monday through Friday on the treadmill. Participants will complete two sessions per day for up to 45 minutes per session, tracking time and speed.
Usual Working Condition Group will be asked to continue working in usual environment and accustomed manner.
Regardless of which group the participants are assigned to, the participants will be asked to complete baseline and follow up assessment visits. Months 3 and 6 for approximately 1 hour for Body measurements (height, weight and waist circumference), body fat percent, gait speed, questionnaires, and accelerometry.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Louisiana
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Baton Rouge, Louisiana, Stati Uniti, 70808
- Pennington Biomedical Research Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Males or females
- BMI ≥ 25 kg/m2
- Willing to give informed consent
- Willing to accept randomization to group assignment and willing to follow the protocol for the group to which they have been assigned
- Willing to maintain fulltime employment at the company for the next 6 months
- Willing to receive frequent contacts and communication from study staff over the next 6 months
Exclusion Criteria:
- Current participation in other Pennington Biomedical research studies
- BMI < 25 kg/m2
- Type 1 diabetes
- Average step count of ≥ 7,500 steps/day
- Self-reporting exercising > 20 minutes on 3 or more days/wk, within the past 6 months
- Unable to walk 45 minutes continuously without taking a rest
- Unable to walk without the use of an assistive device, such as a cane or walker
- Have had a cardiovascular event (stroke or heart attack) in the past 6 months
- Have a pacemaker or any other internal electrical medical device
- Have been diagnosed with Schizophrenia or bipolar disorder
- Have any condition that would limit participation in a physical activity program
- Women who are pregnant, have been pregnant in the last 6 months, or are breastfeeding
- Actively participating in a weight loss program
- Plan to move out of the study area within the next 6 months or plan to be away from work for more than 4 weeks in the next 6 months
- Have another member of household participating in the study
- Have any condition, which, in the opinion of the investigator would impede competence or compliance or possibly hinder completion of the study
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore placebo: Usual Working Condition Group
Participants assigned to the usual working condition control group will continue to work in their usual environment and accustomed manner.
The control group participants will have access to the Workstations at the completion of study.
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Participants will be asked to continue working at their desk in their usual manner.
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Comparatore attivo: WorkStation Intervention Group
Participants will be asked to walk for up to 1.5 hours per day on the treadmill.
This will be split into two 45 minute sessions per day.
Behavioral support will focus on adherence to frequency (attending scheduled sessions).
Participants self-select speed of walking and time (they have up to 45 minutes allotted, but may choose less as they like).
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Participants will be asked to attend 2 scheduled sessions per day of treadmill walking, which will replace their sitting desk time.
Participants will complete 2 sessions per day for 6 months.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Waist
Lasso di tempo: 6 months
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Waist circumference will decrease in workers assigned to the WorkStation working condition relative to the usual working condition.
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6 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Weight Assessments
Lasso di tempo: 6 months
|
Weight will improve in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
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6 months
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Body Fat Percent
Lasso di tempo: 6 months
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Body fat percent will improve in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
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6 months
|
Accelerometry
Lasso di tempo: 6 months
|
Participants' activity level measured by the accelerometer will increase in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
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6 months
|
Gait Speed
Lasso di tempo: 6 months
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Participants' gait speed will improve in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
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6 months
|
Stress
Lasso di tempo: 6 months
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Participants' stress level will decrease in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
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6 months
|
Fatigue
Lasso di tempo: 6 months
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Participants' fatigue level will decrease in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
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6 months
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Quality of life Questionnaire
Lasso di tempo: 6 months
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Participants' quality of life will improve in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
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6 months
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Catrine Tudor-Locke, PhD, Principal Investigator
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- PBRC 12015
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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