Multi-component Workplace Energy Balance Intervention

Study 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.

Official Title
-----------------
Multi-component Workplace Energy Balance Intervention

Conditions
-----------------
Abdominal Obesity

Intervention / Treatment
-----------------
* Behavioral: Intervention Group


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Usual Working Condition Group (UWC) The no-intervention control condition will be asked to maintain their usual work and lifestyle throughout the study. Participants may be contacted by Pennington Biomedical staff during the intervention. | |
| Experimental: Intervention Group<br>Combined Intervention (Walk More and Pedal Desk; WMPD) Participants in the WMPD condition will engage in both step-counting (Walk More, WM) and pedal desk (PD) intervention components. | Behavioral: Intervention Group<br>* The content of both intervention components will be covered during a weekly scheduled group meeting (or face-to-face meetings, as needed). The step-counting component of the WMPD intervention will be modeled off the success of The First Step Program (FSP).<br>* Other names: WMPD;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in abdominal obesity operationalized as MRI-determined visceral adipose tissue (VAT). | Change in MRI-measured abdominal obesity. | 3 -month-long controlled trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body weight | Weight will be measured to the nearest 0.1 kg using a standard stadiometer. | 3-month-long controlled trial | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pedal Desk, Workplace Intervention, Physical Activity, Energy Expenditure