Multi-component Workplace Energy Balance Intervention (WorkACTIVE-P)

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Obesity
• Intervention / Treatment: Behavioral: Intervention Group

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; 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; 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; 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).; Other Names: Walk More and Pedal Desk Group; 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

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Investigators: Principal Investigator: Corby K Martin, PhD, Pennington Biomedical Research Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: September 23, 2015
• First Submitted That Met QC Criteria: September 25, 2015
• First Posted (Estimate): September 28, 2015

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Physical Activity; Energy Expenditure; Pedal Desk; Workplace Intervention
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Obesity; Obesity, Abdominal
• Other Study ID Numbers: PBRC 2015-024; R21OH010785-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO