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Worksite Nutrition Study

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ClinicalTrials.gov Identifier: NCT00481897
Recruitment Status : Completed
First Posted : June 4, 2007
Last Update Posted : August 7, 2012
Sponsor:
Information provided by (Responsible Party):
Physicians Committee for Responsible Medicine

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.

Condition or disease Intervention/treatment Phase
Overweight Type 2 Diabetes Behavioral: low-fat, vegan diet Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Worksite Nutrition Study
Study Start Date : May 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Behavioral: low-fat, vegan diet
    Diet that excludes animal products (i.e. meat, dairy, eggs) and keeps oils to a minimum.


Primary Outcome Measures :
  1. Assignment to a diet intervention program promotes clinically significant weight loss, compared to a control group. [ Time Frame: 22 weeks ]
  2. 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 ]
  3. 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 ]
  4. 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 Measures :
  1. 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 ]
  2. Assignment to the diet intervention program promotes adherence and acceptability. [ Time Frame: 22 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00481897


Locations
United States, District of Columbia
Washington Center for Clinical Research
Washington, District of Columbia, United States, 20016
Sponsors and Collaborators
Physicians Committee for Responsible Medicine
Investigators
Principal Investigator: Hope Ferdowsian, M.D., M.P.H. Washington Center for Clinical Research
Principal Investigator: Neal Barnard, M.D. Washington Center for Clinical Research

Publications of Results:
Responsible Party: Physicians Committee for Responsible Medicine
ClinicalTrials.gov Identifier: NCT00481897     History of Changes
Other Study ID Numbers: WCCR-07065-01
First Posted: June 4, 2007    Key Record Dates
Last Update Posted: August 7, 2012
Last Verified: August 2012

Keywords provided by Physicians Committee for Responsible Medicine:
overweight
obesity
type 2 diabetes
diabetes
worksite cost
nutrition

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Overweight
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Signs and Symptoms