- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01587092
Workstation Pilot Study
WorkStation Pilot Study
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Louisiana
-
Baton Rouge, Louisiana, Spojené státy, 70808
- Pennington Biomedical Research Center
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Komparátor placeba: 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.
|
Participants will be asked to continue working at their desk in their usual manner.
|
Aktivní komparátor: 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).
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Waist
Časové okno: 6 months
|
Waist circumference will decrease in workers assigned to the WorkStation working condition relative to the usual working condition.
|
6 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Weight Assessments
Časové okno: 6 months
|
Weight will improve in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
|
6 months
|
Body Fat Percent
Časové okno: 6 months
|
Body fat percent will improve in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
|
6 months
|
Accelerometry
Časové okno: 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.
|
6 months
|
Gait Speed
Časové okno: 6 months
|
Participants' gait speed will improve in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
|
6 months
|
Stress
Časové okno: 6 months
|
Participants' stress level will decrease in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
|
6 months
|
Fatigue
Časové okno: 6 months
|
Participants' fatigue level will decrease in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
|
6 months
|
Quality of life Questionnaire
Časové okno: 6 months
|
Participants' quality of life will improve in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
|
6 months
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Catrine Tudor-Locke, PhD, Principal Investigator
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
- PBRC 12015
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Usual Working Condition
-
University of PittsburghNational Institute on Deafness and Other Communication Disorders (NIDCD); University...Nábor
-
London Health Sciences CentreDokončeno
-
University of California, San FranciscoNational Heart, Lung, and Blood Institute (NHLBI); Society of Hospital MedicineNáborZápal plic | Astma | BronchiolitidaSpojené státy
-
University of RochesterUkončeno
-
Queen's UniversityCanadian Institutes of Health Research (CIHR)Dokončeno
-
Duke UniversityJohns Hopkins University; The Hartwell FoundationDokončenoOnemocnění sítnice | Onemocnění zrakového nervuSpojené státy
-
University of ChicagoDokončenoJazykové chování rodičůSpojené státy
-
Brown UniversityNational Institute of Mental Health (NIMH)NáborHIV/AIDSSpojené státy
-
Icahn School of Medicine at Mount SinaiNational Institute of Mental Health (NIMH); William Marsh Rice UniversityNáborHraniční porucha osobnostiSpojené státy