Abdominal Obesity
Conditions
Keywords
Pedal Desk, Workplace Intervention, Physical Activity, Energy Expenditure
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.
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).
Sponsors
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visceral Adipose Tissue (VAT), Measured in kg | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in Body Weight | 3-month-long controlled trial | Weight will be measured to the nearest 0.1 kg using a standard stadiometer. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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.
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). | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Control Group | Total | Intervention Group |
|---|---|---|---|
| Age, Continuous | 46.7 years STANDARD_DEVIATION 9.8 | 46.4 years STANDARD_DEVIATION 10.5 | 46.2 years STANDARD_DEVIATION 11.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 12 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 28 Participants | 13 Participants |
| Sex: Female, Male Female | 14 Participants | 31 Participants | 17 Participants |
| Sex: Female, Male Male | 6 Participants | 9 Participants | 3 Participants |
| Weight | 86.1 kg STANDARD_DEVIATION 14 | 87.7 kg STANDARD_DEVIATION 15.14 | 89.6 kg STANDARD_DEVIATION 16.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Control Group | Change in Visceral Adipose Tissue (VAT), Measured in kg | .04 kg |
| Intervention Group | Change in Visceral Adipose Tissue (VAT), Measured in kg | -0.10 kg |
Secondary
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Control Group | Changes in Body Weight | -0.3 kg |
| Intervention Group | Changes in Body Weight | -0.9 kg |