Worksite Nutrition Study

Type 2 Diabetes Clinical Trial

Official title: Worksite Nutrition Study

Status Completed

Clinical Trial 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.

Clinical Trial 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 U.S. 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, n=60) at a specified worksite will be assigned to the diet intervention program, which prescribes a low-fat, vegan diet. A control group (Group 2, n=60) 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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Overweight
• Type 2 Diabetes

• NCT number: NCT00481897
• Study type: Interventional
• Source: Physicians Committee for Responsible Medicine
• Status: Completed
• Phase: N/A
• Start date: May 2007
• Completion date: July 2008