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

Primary Purpose

Abdominal Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention Group
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Abdominal Obesity focused on measuring Pedal Desk, Workplace Intervention, Physical Activity, Energy Expenditure

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Intervention Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in abdominal obesity operationalized as MRI-determined visceral adipose tissue (VAT).
Change in MRI-measured abdominal obesity.

Secondary Outcome Measures

Changes in body weight
Weight will be measured to the nearest 0.1 kg using a standard stadiometer.

Full Information

First Posted
September 23, 2015
Last Updated
January 22, 2020
Sponsor
Pennington Biomedical Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT02561611
Brief Title
Multi-component Workplace Energy Balance Intervention
Acronym
WorkACTIVE-P
Official Title
Multi-component Workplace Energy Balance Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Obesity
Keywords
Pedal Desk, Workplace Intervention, Physical Activity, Energy Expenditure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intervention Group
Other Intervention Name(s)
Walk More and Pedal Desk Group, WMPD
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in abdominal obesity operationalized as MRI-determined visceral adipose tissue (VAT).
Description
Change in MRI-measured abdominal obesity.
Time Frame
3 -month-long controlled trial
Secondary Outcome Measure Information:
Title
Changes in body weight
Description
Weight will be measured to the nearest 0.1 kg using a standard stadiometer.
Time Frame
3-month-long controlled trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corby K Martin, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33451268
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.
Results Reference
derived

Learn more about this trial

Multi-component Workplace Energy Balance Intervention

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