Trial Outcomes & Findings for Multi-component Workplace Energy Balance Intervention (NCT NCT02561611)
NCT ID: NCT02561611
Last Updated: 2024-12-19
Results Overview
Change (end of study minus baseline) in abdominal obesity operationalized as MRI-determined visceral adipose tissue (VAT) and measured in kg.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
3 -month-long controlled trial
Results posted on
2024-12-19
Participant Flow
Participant milestones
| Measure |
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.
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multi-component Workplace Energy Balance Intervention
Baseline characteristics by cohort
| Measure |
Control Group
n=20 Participants
* 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
n=20 Participants
* 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).
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.7 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
46.2 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
46.4 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Weight
|
86.1 kg
STANDARD_DEVIATION 14.0 • n=5 Participants
|
89.6 kg
STANDARD_DEVIATION 16.6 • n=7 Participants
|
87.7 kg
STANDARD_DEVIATION 15.14 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 -month-long controlled trialChange (end of study minus baseline) in abdominal obesity operationalized as MRI-determined visceral adipose tissue (VAT) and measured in kg.
Outcome measures
| Measure |
Control Group
n=20 Participants
* 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
n=20 Participants
* 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).
|
|---|---|---|
|
Change in Visceral Adipose Tissue (VAT), Measured in kg
|
.04 kg
Interval -0.07 to 0.15
|
-0.10 kg
Interval -0.22 to 0.01
|
SECONDARY outcome
Timeframe: 3-month-long controlled trialWeight will be measured to the nearest 0.1 kg using a standard stadiometer.
Outcome measures
| Measure |
Control Group
n=20 Participants
* 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
n=20 Participants
* 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).
|
|---|---|---|
|
Changes in Body Weight
|
-0.3 kg
Interval -1.3 to 0.6
|
-0.9 kg
Interval -1.8 to 0.1
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place