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| ID | Type | Description | Link |
|---|---|---|---|
| R21OH010785-01A1 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention |
| |
| Intervention Group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Body Weight | Weight will be measured to the nearest 0.1 kg using a standard stadiometer. | 3-month-long controlled trial |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corby K Martin, PhD | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33451268 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group |
|
| FG001 | Intervention Group |
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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group |
|
| BG001 | Intervention Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Least Squares Mean | 95% Confidence Interval | kg | 3 -month-long controlled trial |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Corby Martin | Pennington Biomedical Research Center | 225-763-2585 | Corby.Martin@pbrc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 11, 2019 | Dec 17, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D056128 | Obesity, Abdominal |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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|
|
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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
|
|
| Secondary | Changes in Body Weight | Weight will be measured to the nearest 0.1 kg using a standard stadiometer. | Posted | Least Squares Mean | 95% Confidence Interval | kg | 3-month-long controlled trial |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Intervention Group |
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). | 0 | 20 | 0 | 20 | 0 | 20 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |