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Worksite Nutrition Study

Primary Purpose

Overweight, Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
low-fat, vegan diet
Sponsored by
Physicians Committee for Responsible Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring overweight, obesity, type 2 diabetes, diabetes, worksite cost, nutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • employee at the intervention worksite or the control worksite;
  • BMI > 25 or a diagnosis of type 2 diabetes mellitus, as defined by a fasting plasma glucose concentration > 126 mg/dl on two occasions or a prior physician's diagnosis of type 2 diabetes with the use of hypoglycemic medications for at least six months;
  • male or female;
  • age at least 18 years;
  • ability and willingness to participate in all components of the study; and
  • a willingness to be assigned to a low-fat, vegan diet or control group.

Exclusion Criteria:

  • a history of alcohol abuse or dependency followed by any current use;
  • current or unresolved past drug abuse;
  • pregnancy;
  • history of severe mental illness;
  • unstable medical status;
  • already following a low-fat, vegetarian diet;
  • an inordinate fear of blood draw; and
  • A1c <7 or >10.5% (for volunteers with diabetes).

Sites / Locations

  • Washington Center for Clinical Research

Outcomes

Primary Outcome Measures

Assignment to a diet intervention program promotes clinically significant weight loss, compared to a control group.
Assignment to the diet intervention program improves indices of cardiovascular risk, including plasma lipid concentrations and blood pressure, compared to a control group.
Assignment to the diet intervention program improves glycemia in a sub-group of participants with type 2 diabetes, as indicated by mean A1c, relative to matched participants with type 2 diabetes in the control group.
Assignment to the diet intervention, decreases the prevalence of work absenteeism, as measured by the proportion of days that a participant is absent from work, compared with assignment to a control group.

Secondary Outcome Measures

Assignment to the diet intervention improves quality of life measures, including general mental and physical health, relative to assignment to a control group.
Assignment to the diet intervention program promotes adherence and acceptability.

Full Information

First Posted
May 31, 2007
Last Updated
August 6, 2012
Sponsor
Physicians Committee for Responsible Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00481897
Brief Title
Worksite Nutrition Study
Official Title
Worksite Nutrition Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Physicians Committee for Responsible Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Type 2 Diabetes
Keywords
overweight, obesity, type 2 diabetes, diabetes, worksite cost, nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
low-fat, vegan diet
Intervention Description
Diet that excludes animal products (i.e. meat, dairy, eggs) and keeps oils to a minimum.
Primary Outcome Measure Information:
Title
Assignment to a diet intervention program promotes clinically significant weight loss, compared to a control group.
Time Frame
22 weeks
Title
Assignment to the diet intervention program improves indices of cardiovascular risk, including plasma lipid concentrations and blood pressure, compared to a control group.
Time Frame
22 weeks
Title
Assignment to the diet intervention program improves glycemia in a sub-group of participants with type 2 diabetes, as indicated by mean A1c, relative to matched participants with type 2 diabetes in the control group.
Time Frame
22 weeks
Title
Assignment to the diet intervention, decreases the prevalence of work absenteeism, as measured by the proportion of days that a participant is absent from work, compared with assignment to a control group.
Time Frame
22 weeks
Secondary Outcome Measure Information:
Title
Assignment to the diet intervention improves quality of life measures, including general mental and physical health, relative to assignment to a control group.
Time Frame
22 weeks
Title
Assignment to the diet intervention program promotes adherence and acceptability.
Time Frame
22 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: employee at the intervention worksite or the control worksite; BMI > 25 or a diagnosis of type 2 diabetes mellitus, as defined by a fasting plasma glucose concentration > 126 mg/dl on two occasions or a prior physician's diagnosis of type 2 diabetes with the use of hypoglycemic medications for at least six months; male or female; age at least 18 years; ability and willingness to participate in all components of the study; and a willingness to be assigned to a low-fat, vegan diet or control group. Exclusion Criteria: a history of alcohol abuse or dependency followed by any current use; current or unresolved past drug abuse; pregnancy; history of severe mental illness; unstable medical status; already following a low-fat, vegetarian diet; an inordinate fear of blood draw; and A1c <7 or >10.5% (for volunteers with diabetes).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hope Ferdowsian, M.D., M.P.H.
Organizational Affiliation
Washington Center for Clinical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neal Barnard, M.D.
Organizational Affiliation
Washington Center for Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington Center for Clinical Research
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20074388
Citation
Levin SM, Ferdowsian HR, Hoover VJ, Green AA, Barnard ND. A worksite programme significantly alters nutrient intakes. Public Health Nutr. 2010 Oct;13(10):1629-35. doi: 10.1017/S136898000999303X. Epub 2010 Jan 15.
Results Reference
result
PubMed Identifier
20389060
Citation
Katcher HI, Ferdowsian HR, Hoover VJ, Cohen JL, Barnard ND. A worksite vegan nutrition program is well-accepted and improves health-related quality of life and work productivity. Ann Nutr Metab. 2010;56(4):245-52. doi: 10.1159/000288281. Epub 2010 Apr 14.
Results Reference
result
PubMed Identifier
20594095
Citation
Ferdowsian HR, Barnard ND, Hoover VJ, Katcher HI, Levin SM, Green AA, Cohen JL. A multicomponent intervention reduces body weight and cardiovascular risk at a GEICO corporate site. Am J Health Promot. 2010 Jul-Aug;24(6):384-7. doi: 10.4278/ajhp.081027-QUAN-255.
Results Reference
result

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Worksite Nutrition Study

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