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Completed

NCT Number: NCT02561611

Multi-component Workplace Energy Balance Intervention

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention Group

Behavioral

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

Primary outcomes

  1. Change in Visceral Adipose Tissue (VAT), Measured in kg

    Time frame: 3 -month-long controlled trial

    Change (end of study minus baseline) in abdominal obesity operationalized as MRI-determined visceral adipose tissue (VAT) and measured in kg.

Secondary outcomes

  1. Changes in Body Weight

    Time frame: 3-month-long controlled trial

    Weight will be measured to the nearest 0.1 kg using a standard stadiometer.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Acronym: WorkACTIVE-P

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 28, 2015
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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