Clinical trial NCT02561611: Multi-component Workplace Energy Balance Intervention
Official title: Multi-component Workplace Energy Balance Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Obesity
Keywords: Pedal Desk
Workplace Intervention
Physical Activity
Energy Expenditure
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2015-09-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in Visceral Adipose Tissue (VAT), Measured in kg
timeFrame: 3 -month-long controlled trial
Secondary outcomes:
measure: Changes in Body Weight
timeFrame: 3-month-long controlled trial
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Corby K Martin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dorling JL, Hochsmann C, Tudor-Locke C, Beyl R, Martin CK. Effect of an office-based intervention on visceral adipose tissue: the WorkACTIVE-P randomized controlled trial. Appl Physiol Nutr Metab. 2021 Feb;46(2):117-125. doi: 10.1139/apnm-2020-0175. Epub 2021 Jan 15.