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CompletedNCT02561611WorkACTIVE-PUpdated Dec 19, 2024Results posted

Multi-component Workplace Energy Balance Intervention

An interventional study of Intervention Group in Abdominal Obesity, sponsored by Pennington Biomedical Research Center. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2024-12-19.

Sponsored by Pennington Biomedical Research Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Abdominal Obesity

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Keywords

  • Pedal Desk
  • Workplace Intervention
  • Physical Activity
  • Energy Expenditure
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In context

Obesity, Abdominal

274 studies on the registry are indexed under Obesity, Abdominal; 44 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 216 interventional studies indexed under Obesity, Abdominal.

Browse Obesity, Abdominal studies →

Lead sponsor

Pennington Biomedical Research Center is the lead sponsor of 277 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralIntervention 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).

    Also known as: Walk More and Pedal Desk Group, WMPD

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What researchers measure

Primary outcomes

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

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

    Time frame: 3 -month-long controlled trial

Secondary outcomes

  1. Changes in Body Weight

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

    Time frame: 3-month-long controlled trial

07

Results

Posted Dec 19, 2024

Participant flow

Participant flow — Overall Study
MilestoneControl GroupIntervention Group
Started2020
Completed2020
Not completed00

Outcome measures

PrimaryChange in Visceral Adipose Tissue (VAT), Measured in kg

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

Time frame:
3 -month-long controlled trial
Reported as:
Least squares mean · kg
Change in Visceral Adipose Tissue (VAT), Measured in kg
kgControl GroupIntervention Group
Change in Visceral Adipose Tissue (VAT), Measured in kg.04 (-0.07 to 0.15)-0.10 (-0.22 to 0.01)
SecondaryChanges in Body Weight

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

Time frame:
3-month-long controlled trial
Reported as:
Least squares mean · kg
Changes in Body Weight
kgControl GroupIntervention Group
Changes in Body Weight-0.3 (-1.3 to 0.6)-0.9 (-1.8 to 0.1)

Adverse events

Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Control Group0/20 (0%)0/20 (0%)0/20 (0%)
Intervention Group0/20 (0%)0/20 (0%)0/20 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Control GroupIntervention GroupTotal
Mean46.7 ± 9.846.2 ± 11.446.4 ± 10.5
Sex: Female, Male
Sex: Female, Male(Participants)Control GroupIntervention GroupTotal
Female141731
Male639
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Control GroupIntervention GroupTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American5712
White151328
More than one race000
Unknown or Not Reported000
Weight
Weight(kg)Control GroupIntervention GroupTotal
Mean86.1 ± 14.089.6 ± 16.687.7 ± 15.14
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Study locations

1 site
  • Pennington Biomedical Research Center
    Baton Rouge, Louisiana 70808, United States
09

References and documents

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. PubMed 33451268 ↗

Study documents

  • Protocol and statistical analysis plan · Nov 11, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02561611
Lead sponsor
Pennington Biomedical Research Center
Responsible party
Corby K. Martin (Professor, Pennington Biomedical Research Center) — Principal investigator
First posted
Sep 28, 2015
Start date
Jun 2016
Primary completion
May 2018
Completion
May 2018
Results posted
Dec 19, 2024
Last update
Dec 19, 2024

Study contacts

Corby K Martin, PhD
principal investigator · Pennington Biomedical Research Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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