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Clinical Trials/NCT02561611
NCT02561611
Completed
Not Applicable

Multi-component Workplace Energy Balance Intervention

Pennington Biomedical Research Center1 site in 1 country40 target enrollmentJune 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Abdominal Obesity
Sponsor
Pennington Biomedical Research Center
Enrollment
40
Locations
1
Primary Endpoint
Change in Visceral Adipose Tissue (VAT), Measured in kg
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of the WorkACTIVE-P study is to assess the outcome of an innovative multi-component intervention focused on increasing energy expenditure and re-balancing the disrupted energy balance equation of sedentary workplaces with an ultimate target of reducing workers' abdominal obesity.

Detailed Description

The energy expenditure intervention includes replacing workplace sedentary time with access to a dedicated pedal desk and increasing steps/day with wearable monitors. Both components are incorporated into an electronically-delivered behavior monitoring and support infrastructure, thus enabling continuous management. The investigators will utilize pedaldesks manufactured and owned by Pennington Biomedical Research Center to conduct this study at Blue Cross Blue Shield of Louisiana offices in Baton Rouge, La. 40 individuals will be recruited and randomized to either a control arm or combined Walk More Pedal Desk (WMPD) intervention. Primary (MRI-determined visceral adipose tissue) and secondary (changes in body weight, total adipose tissue, subcutaneous adipose tissue, blood pressure, blood lipids, fasting glucose and insulin, HbA1-c, free-living accelerometer-determined walking, time spent in sedentary behavior, exercise, and dietary intake) outcomes will be assessed at baseline and month 3.

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
May 2018
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Corby K. Martin

Professor

Pennington Biomedical Research Center

Eligibility Criteria

Inclusion Criteria

  • BMI: \> or equal to 25.0 kg/m2 and \< or equal to 40 kg/m2
  • Waist Circumference: \>102 cm (men) or \> 88 cm (women)
  • Any one of the other four defining risk factors defining metabolic syndrome (Triglycerides \> or equal to 150 mg/dL , HDL Cholesterol \< 40 mg/dL (men) or \< 50 mg/dL (women), Resting blood pressure \> or equal to 130 mm Hg systolic / 85 mm Hg diastolic, Fasting glucose \> or equal to 110 mg/dL)

Exclusion Criteria

  • Systolic blood pressure \> 179 mmHg and/or diastolic blood pressure \> 99 mmHg
  • Self-reported Type 1 or Type 2 diabetes, or use of diabetes-related medications
  • Significant CVD or disorders
  • Other significant medical conditions including but not limited to implants that may interfere with MRI, chronic respiratory, gastrointestinal, neuromuscular, or psychiatric conditions, malignancies in the past 5 years, with the exception of skin cancer therapeutically controlled, endocrine (including diabetes), any other medical conditions or disease (including arthritis) that is life threatening or that can interfere with or be aggravated by exercise.
  • Poor compliance to activity monitors

Outcomes

Primary Outcomes

Change in Visceral Adipose Tissue (VAT), Measured in kg

Time Frame: 3 -month-long controlled trial

Change (end of study minus baseline) in abdominal obesity operationalized as MRI-determined visceral adipose tissue (VAT) and measured in kg.

Secondary Outcomes

  • Changes in Body Weight(3-month-long controlled trial)

Study Sites (1)

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