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Multicenter Worksite Nutrition Study (WNS2)

Primary Purpose

Diabetes, Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
vegan instruction and food accessibility
control
Sponsored by
Physicians Committee for Responsible Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes focused on measuring vegan, diet, diabetes, overweight, workplace, nutrition, diabetes and/or overweight

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tucson
  • San Diego
  • Lakeland
  • Macon
  • Chevy Chase
  • Buffalo
  • Woodbury
  • Dallas
  • Fredericksburg
  • Virginia Beach

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

vegan group

control group

Arm Description

participants from sites of this group will receive vegan nutritional intervention starting from Feb 2011

participants from sites of the control group will not receive the same nutritional information until June 2011

Outcomes

Primary Outcome Measures

weight
body weight at baseline
weight
body weight at the end of 4 months
weight
body weight at the end of 12 months

Secondary Outcome Measures

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

Full Information

First Posted
August 30, 2010
Last Updated
January 23, 2013
Sponsor
Physicians Committee for Responsible Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01224548
Brief Title
Multicenter Worksite Nutrition Study
Acronym
WNS2
Official Title
Multicenter Worksite Nutrition Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
October 2011 (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 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Overweight
Keywords
vegan, diet, diabetes, overweight, workplace, nutrition, diabetes and/or overweight

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
292 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vegan group
Arm Type
Experimental
Arm Description
participants from sites of this group will receive vegan nutritional intervention starting from Feb 2011
Arm Title
control group
Arm Type
No Intervention
Arm Description
participants from sites of the control group will not receive the same nutritional information until June 2011
Intervention Type
Other
Intervention Name(s)
vegan instruction and food accessibility
Intervention Description
weekly 1-hr instructions including vegan nutritional information and cooking instructions. vegan menu will be made available at the cafeteria
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
no intervention in until June 2011. The control group start vegan diet in July 2011.
Primary Outcome Measure Information:
Title
weight
Description
body weight at baseline
Time Frame
0 months
Title
weight
Description
body weight at the end of 4 months
Time Frame
18 weeks
Title
weight
Description
body weight at the end of 12 months
Time Frame
10 months
Secondary Outcome Measure Information:
Title
blood pressure
Description
diastolic and systolic blood pressures at baseline
Time Frame
0 months
Title
blood pressure
Description
diastolic and systolic blood pressures at the end of 4 months
Time Frame
18 weeks
Title
blood pressure
Description
diastolic and systolic blood pressures at the end of 12 months
Time Frame
10 months
Title
waist circumference
Description
measurement of waist circumference at baseline
Time Frame
0 month
Title
waist circumference
Description
measurement of waist circumference at 4 months
Time Frame
18 weeks
Title
waist circumference
Description
measurement of waist circumference at 12 months
Time Frame
10 months
Title
absenteeism
Description
number of days absent because of sickness over the past 6 months, surveyed at baseline
Time Frame
0 month
Title
absenteeism
Description
number of days absent because of sickness over the past 4 months, surveyed at the end of 4 months.
Time Frame
18 weeks
Title
absenteeism
Description
number of days absent because of sickness over the past 6 months, surveyed at the end of 12 months.
Time Frame
10 months
Title
health insurance utilization
Description
categorized payments by health insurance company for health-related coverage over the past 12 months, surveyed at baseline
Time Frame
0 month
Title
healthy insurance utilization
Description
categorized payments by health insurance company for health-related coverage over the past 12 months, surveyed at the end of 12 months
Time Frame
12 months
Title
blood lipid panel
Description
blood test of Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), total cholesterol, and triglyceride at baseline
Time Frame
0 month
Title
blood lipid panel
Description
blood test of Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), total cholesterol, and triglyceride at the end of 4 months
Time Frame
18 weeks
Title
blood lipid panel
Description
blood test of Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), total cholesterol, and triglyceride at the end of 12 months
Time Frame
10 months
Title
quality of life
Description
questionnaire on quality of life measurements surveyed at baseline
Time Frame
0 month
Title
quality of life
Description
questionnaire on quality of life measurements surveyed at the end of 4 months
Time Frame
18 weeks
Title
quality of life
Description
questionnaire on quality of life measurements surveyed at the end of 12 months
Time Frame
10 months
Title
hemoglobin A1c
Description
blood test of hemoglobin A1c level (for diabetic participants only) at baseline
Time Frame
0 month
Title
hemoglobin A1c
Description
blood test of hemoglobin A1c level (for diabetic participants only) at the end of 4 months
Time Frame
18 weeks
Title
hemoglobin A1c
Description
blood test of hemoglobin A1c level (for diabetic participants only) at the end of 12 months
Time Frame
10 months
Title
hip circumference
Description
measurement of hip circumference at baseline
Time Frame
0 month
Title
hip circumference
Description
measurement of hip circumference at the end of 4 months
Time Frame
18 weeks
Title
hip circumference
Description
measurement of hip circumference at the end of 12 months
Time Frame
10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
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
Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Lakeland
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33811
Country
United States
Facility Name
Macon
City
Macon
State/Province
Georgia
ZIP/Postal Code
31295
Country
United States
Facility Name
Chevy Chase
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14068
Country
United States
Facility Name
Woodbury
City
Woodbury
State/Province
New York
ZIP/Postal Code
11797
Country
United States
Facility Name
Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75244
Country
United States
Facility Name
Fredericksburg
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22412
Country
United States
Facility Name
Virginia Beach
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States

12. IPD Sharing Statement

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Multicenter Worksite Nutrition Study

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