NCT01371084

Brief Summary

The primary aim of this pilot study is to test the efficacy of a worksite intervention for reducing daily sedentary time and improving risk factors for cardiometabolic disease (e.g., measures of adiposity, anthropometrics, cardiorespiratory fitness) among sedentary, overweight, full-time working adults as compared to a waitlist control. A secondary aim will be to test pedal time at work as a measure of compliance with the intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

January 17, 2014

Status Verified

January 1, 2014

Enrollment Period

1 year

First QC Date

June 8, 2011

Last Update Submit

January 16, 2014

Conditions

Physical Activity

Outcome Measures

Primary Outcomes (1)

  • Step Watch - Physical Activity Minutes

    Participants will wear a Step Watch monitor for 7 days at baseline and post-intervention. The intervention time period is 12 weeks.

    12 weeks between baseline and post-intervention follow up

Secondary Outcomes (1)

  • Cardiometabolic Risk

    12 weeks between baseline and post-intervention follow up

Study Arms (2)

Physical activity treatment group

EXPERIMENTAL

Participants randomized to the intervention group will be provided access to a portable pedal exercise machine, a pedometer and a worksite wellness motivational website for 12 weeks. As part of this website, participants will be emailed behavioral intervention materials a maximum of three times per week targeted at reducing sedentary time.

Behavioral: Pedal@Work

Wait List Control

PLACEBO COMPARATOR
Behavioral: Pedal@Work Worksite Wellness

Interventions

Pedal@Work Worksite WellnessBEHAVIORAL

Participants randomized to the intervention group will be provided access to a portable pedal exercise machine, a pedometer and a worksite wellness motivational website for 12 weeks. As part of this website, participants will be emailed behavioral intervention materials a maximum of three times per week targeted at reducing sedentary time.

Wait List Control
Pedal@WorkBEHAVIORAL

Worksite wellness program.

Physical activity treatment group

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults between 21 and 65 years
  • Sedentary (engaging in moderate intensity physical activity for less than 60 minutes per week)
  • Working full time (35+ hours/week) at a sedentary desk dependant occupation
  • Overweight (Body Mass Index \> 25.0 kg/m2 but less than 40.0 kg/2)
  • Apparently healthy as assessed by a health history screening survey
  • Devoid of overt complicated or acute cardiovascular, metabolic, respiratory, or neurological diseases
  • Free from exercise/physical activity limitations

You may not qualify if:

  • Adults with significant health problems exacerbated by exercise, such as uncontrolled hypertension, diabetes, orthopedic limitations, etc. will be excluded from the study. Note, with physician approval and adequate control of these health problems, these conditions will not necessarily preclude participation.
  • Being unable to exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Carolina University

Greenville, North Carolina, 27858, United States

Location

Related Publications (1)

  • Carr LJ, Karvinen K, Peavler M, Smith R, Cangelosi K. Multicomponent intervention to reduce daily sedentary time: a randomised controlled trial. BMJ Open. 2013 Oct 18;3(10):e003261. doi: 10.1136/bmjopen-2013-003261.

    PMID: 24141969DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Lucas J Carr, Ph.D.

    East Carolina University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 8, 2011

First Posted

June 10, 2011

Study Start

June 1, 2011

Primary Completion

June 1, 2012

Study Completion

August 1, 2012

Last Updated

January 17, 2014

Record last verified: 2014-01

Locations

US(1)