- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01587092
Workstation Pilot Study
WorkStation Pilot Study
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Louisiana
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Baton Rouge, Louisiana, Förenta staterna, 70808
- Pennington Biomedical Research Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Placebo-jämförare: 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.
|
Aktiv komparator: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Waist
Tidsram: 6 months
|
Waist circumference will decrease in workers assigned to the WorkStation working condition relative to the usual working condition.
|
6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Weight Assessments
Tidsram: 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
|
Body Fat Percent
Tidsram: 6 months
|
Body fat percent will improve in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
|
6 months
|
Accelerometry
Tidsram: 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
Tidsram: 6 months
|
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
Tidsram: 6 months
|
Participants' stress level will decrease in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
|
6 months
|
Fatigue
Tidsram: 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
Tidsram: 6 months
|
Participants' quality of life will improve in workers assigned to the WorkStation Group relative to the Usual Working Condition Group.
|
6 months
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Catrine Tudor-Locke, PhD, Principal Investigator
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- PBRC 12015
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