Multicenter Worksite Nutrition Study

Study Overview
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Brief Summary
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The purpose of this study is to study the potential benefits of low fat vegan diet in a randomized, controlled and multi-centered workplace setting, the investigators will enroll participants from 10 worksites of Government Employee Insurance Company (GEICO). After randomization, 5 will be the vegan sites and 5 will be the control sites for 10 month study. The vegan sites will receive low fat vegan diet instructions and weekly group sessions starting from year 1. no intervention is done to the control sites until the week 18 when the identical program will be given. At various time points, health measurements will be give to all participants.

Detailed Description
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The purpose of this study is to study the weight loss and other potential benefits of low fat vegan diet as compared to the standard American diet in a randomized, controlled and multi-centered workplace setting. The 10 months study involves 5 vegan sites and 5 control sites generated through a random process after recruitment. The vegan sites will receive low fat vegan diet instructions and weekly group sessions starting from the January, 2011. The control sites will also receive identical instructions starting from the 5th month and lasting for 18 weeks. For each participant at baseline and week 18 a blood test will be conducted, along with blood pressure, weight, hip and waist measurements. A questionnaire will also be administered during these time points to assess dietary intake, work productivity, quality of life, and healthcare utilization. At the end of one year, information about health insurance utilization will be obtained from Health Maintenance Organization(HMO) or Preferred Provider Organization(PPO) for each participant.

Official Title
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Multicenter Worksite Nutrition Study

Conditions
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Diabetes, Overweight

Intervention / Treatment
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* Other: vegan instruction and food accessibility
* Other: control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Paid employee at a participating GEICO worksite for at least 6 months Currently a full-time employee at GEICO working for GEICO (at least 38.75 hours/week) Age of at least 18 years Ability and willingness to participate in all components of the study A willingness to be assigned to the vegan diet group or the control group Body mass index ≥ 25 kg/m2 and/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 Exclusion Criteria: A history of alcohol abuse or dependency followed by any current use Current or unresolved past drug abuse Pregnancy or plans to become pregnant in the next 12 months Intention to leave GEICO in the next 12 months History of severe mental illness Unstable medical status Already following a low-fat, vegetarian diet An inordinate fear of blood draws Previously participated in GEICO two site study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vegan group<br>participants from sites of this group will receive vegan nutritional intervention starting from Feb 2011 | Other: vegan instruction and food accessibility<br>* weekly 1-hr instructions including vegan nutritional information and cooking instructions. vegan menu will be made available at the cafeteria<br>Other: control<br>* no intervention in until June 2011. The control group start vegan diet in July 2011.<br>|
| No Intervention: control group<br>participants from sites of the control group will not receive the same nutritional information until June 2011 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight | body weight at baseline | 0 months | 
| weight | body weight at the end of 4 months | 18 weeks | 
| weight | body weight at the end of 12 months | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure | diastolic and systolic blood pressures at baseline | 0 months | 
| blood pressure | diastolic and systolic blood pressures at the end of 4 months | 18 weeks | 
| blood pressure | diastolic and systolic blood pressures at the end of 12 months | 10 months | 
| waist circumference | measurement of waist circumference at baseline | 0 month | 
| waist circumference | measurement of waist circumference at 4 months | 18 weeks | 
| waist circumference | measurement of waist circumference at 12 months | 10 months | 
| absenteeism | number of days absent because of sickness over the past 6 months, surveyed at baseline | 0 month | 
| absenteeism | number of days absent because of sickness over the past 4 months, surveyed at the end of 4 months. | 18 weeks | 
| absenteeism | number of days absent because of sickness over the past 6 months, surveyed at the end of 12 months. | 10 months | 
| health insurance utilization | categorized payments by health insurance company for health-related coverage over the past 12 months, surveyed at baseline | 0 month | 
| healthy insurance utilization | categorized payments by health insurance company for health-related coverage over the past 12 months, surveyed at the end of 12 months | 12 months | 
| blood lipid panel | blood test of Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), total cholesterol, and triglyceride at baseline | 0 month | 
| blood lipid panel | blood test of Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), total cholesterol, and triglyceride at the end of 4 months | 18 weeks | 
| blood lipid panel | blood test of Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), total cholesterol, and triglyceride at the end of 12 months | 10 months | 
| quality of life | questionnaire on quality of life measurements surveyed at baseline | 0 month | 
| quality of life | questionnaire on quality of life measurements surveyed at the end of 4 months | 18 weeks | 
| quality of life | questionnaire on quality of life measurements surveyed at the end of 12 months | 10 months | 
| hemoglobin A1c | blood test of hemoglobin A1c level (for diabetic participants only) at baseline | 0 month | 
| hemoglobin A1c | blood test of hemoglobin A1c level (for diabetic participants only) at the end of 4 months | 18 weeks | 
| hemoglobin A1c | blood test of hemoglobin A1c level (for diabetic participants only) at the end of 12 months | 10 months | 
| hip circumference | measurement of hip circumference at baseline | 0 month | 
| hip circumference | measurement of hip circumference at the end of 4 months | 18 weeks | 
| hip circumference | measurement of hip circumference at the end of 12 months | 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vegan, diet, diabetes, overweight, workplace, nutrition, diabetes and/or overweight