Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00481897
Status:
COMPLETED
Last Update Posted:
2012-08-07
First Post:
2007-05-31
Brief Title:
Worksite Nutrition Study
Sponsor:
Physicians Committee for Responsible Medicine
Organization:
Physicians Committee for Responsible Medicine
Study Overview
Official Title:
Worksite Nutrition Study
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Worksite Nutrition Study is 22-week translational study aimed at determining how well a worksite-based nutrition program as compared to a control group is able to 1 produce clinically significant weight-loss 2 improve cardiovascular factors 3 decrease work absenteeism 4 improve overall quality of life 5 improve diabetes control in participants with diabetes and 6 promote dietary adherence and acceptability The nutrition program for the intervention group consists of once-weekly group meetings where participants will receive group support and nutrition education on a low-fat vegan diet
Detailed Description:
Approximately 65 percent of Americans are overweight or obese They are at increased risk for diabetes hypertension dyslipidemia cardiovascular disease arthritis respiratory disorders pregnancy complications and premature death Research has demonstrated that weight status is associated with certain types of malignancies including endometrial colon gall bladder prostate kidney and postmenopausal breast cancer The total direct and indirect costs attributed to overweight and obesity amounted to 117 billion US dollars in 2000
The 22-week Worksite Nutrition Study will 1 test whether a worksite intervention which prescribes a low-fat vegan diet is effective in promoting clinically significant weight loss 2 evaluate whether the intervention reduces cardiovascular risk particularly blood pressure and lipid concentrations 3 assess whether the intervention improves glycemic control in individuals with type 2 diabetes and 4 examine how the intervention affects work impairment and absenteeism
Participants Group 1 n60 at a specified worksite will be assigned to the diet intervention program which prescribes a low-fat vegan diet A control group Group 2 n60 will be designated at a separate worksite The participants in the control group will not receive an active intervention during the designated study period Participants in the active intervention will attend weekly group meetings for nutrition education on the intervention diet
Diets will be assessed in order to monitor adherence and for the purposes of comparison in the intervention and control groups at baseline and at weeks 11 and 22 using a 3-day dietary record Dependent measures including body weight blood pressure lipid concentrations quality-of-life measures and A1c for those with diabetes will be assessed in the intervention and control groups at weeks 0 11 and 22
The 22-week Worksite Nutrition Study will 1 test whether a worksite intervention which prescribes a low-fat vegan diet is effective in promoting clinically significant weight loss 2 evaluate whether the intervention reduces cardiovascular risk particularly blood pressure and lipid concentrations 3 assess whether the intervention improves glycemic control in individuals with type 2 diabetes and 4 examine how the intervention affects work impairment and absenteeism
Participants Group 1 n60 at a specified worksite will be assigned to the diet intervention program which prescribes a low-fat vegan diet A control group Group 2 n60 will be designated at a separate worksite The participants in the control group will not receive an active intervention during the designated study period Participants in the active intervention will attend weekly group meetings for nutrition education on the intervention diet
Diets will be assessed in order to monitor adherence and for the purposes of comparison in the intervention and control groups at baseline and at weeks 11 and 22 using a 3-day dietary record Dependent measures including body weight blood pressure lipid concentrations quality-of-life measures and A1c for those with diabetes will be assessed in the intervention and control groups at weeks 0 11 and 22
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None