NCT02561611

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
6.6 years until next milestone

Results Posted

Study results publicly available

December 19, 2024

Completed
Last Updated

December 19, 2024

Status Verified

December 1, 2024

Enrollment Period

1.9 years

First QC Date

September 23, 2015

Results QC Date

October 31, 2024

Last Update Submit

December 17, 2024

Conditions

Abdominal Obesity

Keywords

Pedal DeskWorkplace InterventionPhysical ActivityEnergy Expenditure

Outcome Measures

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.

    3 -month-long controlled trial

Secondary Outcomes (1)

  • Changes in Body Weight

    3-month-long controlled trial

Study Arms (2)

Control Group

NO INTERVENTION

* 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.

Intervention Group

EXPERIMENTAL

* 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

Intervention GroupBEHAVIORAL

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
Intervention Group

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

  • 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.

    PMID: 33451268DERIVED

MeSH Terms

Conditions

Obesity, AbdominalMotor Activity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Results Point of Contact

Title
Corby Martin
Organization
Pennington Biomedical Research Center
Corby.Martin@pbrc.edu
225-763-2585

Study Officials

  • Corby K Martin, PhD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 23, 2015

First Posted

September 28, 2015

Study Start

June 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

December 19, 2024

Results First Posted

December 19, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)