Multi-component Workplace Energy Balance Intervention

Abdominal Obesity Clinical Trial

— WorkACTIVE-P  

Official title:

Multi-component Workplace Energy Balance Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02561611
• Other study ID #: PBRC 2015-024
• Secondary ID: R21OH010785-01A1
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: May 2018

Study information

• Verified date: January 2020
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Obesity
• Obesity, Abdominal

Intervention

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).

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in abdominal obesity operationalized as MRI-determined visceral adipose tissue (VAT).	Change in MRI-measured abdominal obesity.	3 -month-long controlled trial
Secondary	Changes in body weight	Weight will be measured to the nearest 0.1 kg using a standard stadiometer.	3-month-long controlled trial