Multicenter Worksite Nutrition Study (WNS2)

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Overweight
• Intervention / Treatment: Other: vegan instruction and food accessibility; Other: control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 292
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85710
      • Tucson
  • California
    • San Diego, California, United States, 92064
      • San Diego
  • Florida
    • Lakeland, Florida, United States, 33811
      • Lakeland
  • Georgia
    • Macon, Georgia, United States, 31295
      • Macon
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Chevy Chase
  • New York
    • Buffalo, New York, United States, 14068
      • Buffalo
    • Woodbury, New York, United States, 11797
      • Woodbury
  • Texas
    • Dallas, Texas, United States, 75244
      • Dallas
  • Virginia
    • Fredericksburg, Virginia, United States, 22412
      • Fredericksburg
    • Virginia Beach, Virginia, United States, 23454
      • Virginia Beach

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Physicians Committee for Responsible Medicine
• Investigators: Principal Investigator: Neal Barnard, M.D., Washington Center for Clinical Research

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: August 30, 2010
• First Submitted That Met QC Criteria: October 18, 2010
• First Posted (Estimate): October 20, 2010

Study Record Updates

• Last Update Posted (Estimate): January 24, 2013
• Last Update Submitted That Met QC Criteria: January 23, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: diabetes; overweight; nutrition; diet; vegan; workplace; diabetes and/or overweight
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: WCCR-WNS2