Multicenter Worksite Nutrition Study (WNS2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Physicians Committee for Responsible Medicine
ClinicalTrials.gov Identifier:
NCT01224548
First received: August 30, 2010
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Diabetes
Overweight
Other: vegan instruction and food accessibility
Other: control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Multicenter Worksite Nutrition Study

Resource links provided by NLM:


Further study details as provided by Physicians Committee for Responsible Medicine:

Primary Outcome Measures:
  • weight [ Time Frame: 0 months ] [ Designated as safety issue: No ]
    body weight at baseline

  • weight [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    body weight at the end of 4 months

  • weight [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    body weight at the end of 12 months


Secondary Outcome Measures:
  • blood pressure [ Time Frame: 0 months ] [ Designated as safety issue: No ]
    diastolic and systolic blood pressures at baseline

  • blood pressure [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    diastolic and systolic blood pressures at the end of 4 months

  • blood pressure [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    diastolic and systolic blood pressures at the end of 12 months

  • waist circumference [ Time Frame: 0 month ] [ Designated as safety issue: No ]
    measurement of waist circumference at baseline

  • waist circumference [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    measurement of waist circumference at 4 months

  • waist circumference [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    measurement of waist circumference at 12 months

  • absenteeism [ Time Frame: 0 month ] [ Designated as safety issue: No ]
    number of days absent because of sickness over the past 6 months, surveyed at baseline

  • absenteeism [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    number of days absent because of sickness over the past 4 months, surveyed at the end of 4 months.

  • absenteeism [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    number of days absent because of sickness over the past 6 months, surveyed at the end of 12 months.

  • health insurance utilization [ Time Frame: 0 month ] [ Designated as safety issue: No ]
    categorized payments by health insurance company for health-related coverage over the past 12 months, surveyed at baseline

  • healthy insurance utilization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0 month ] [ Designated as safety issue: No ]
    blood test of Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), total cholesterol, and triglyceride at baseline

  • blood lipid panel [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    blood test of Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), total cholesterol, and triglyceride at the end of 4 months

  • blood lipid panel [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    blood test of Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), total cholesterol, and triglyceride at the end of 12 months

  • quality of life [ Time Frame: 0 month ] [ Designated as safety issue: No ]
    questionnaire on quality of life measurements surveyed at baseline

  • quality of life [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    questionnaire on quality of life measurements surveyed at the end of 4 months

  • quality of life [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    questionnaire on quality of life measurements surveyed at the end of 12 months

  • hemoglobin A1c [ Time Frame: 0 month ] [ Designated as safety issue: No ]
    blood test of hemoglobin A1c level (for diabetic participants only) at baseline

  • hemoglobin A1c [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    blood test of hemoglobin A1c level (for diabetic participants only) at the end of 4 months

  • hemoglobin A1c [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    blood test of hemoglobin A1c level (for diabetic participants only) at the end of 12 months

  • hip circumference [ Time Frame: 0 month ] [ Designated as safety issue: No ]
    measurement of hip circumference at baseline

  • hip circumference [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    measurement of hip circumference at the end of 4 months

  • hip circumference [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    measurement of hip circumference at the end of 12 months


Enrollment: 292
Study Start Date: October 2010
Study Completion Date: October 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01224548

Locations
United States, Arizona
Tucson
Tucson, Arizona, United States, 85710
United States, California
San Diego
San Diego, California, United States, 92064
United States, Florida
Lakeland
Lakeland, Florida, United States, 33811
United States, Georgia
Macon
Macon, Georgia, United States, 31295
United States, Maryland
Chevy Chase
Chevy Chase, Maryland, United States, 20815
United States, New York
Buffalo
Buffalo, New York, United States, 14068
Woodbury
Woodbury, New York, United States, 11797
United States, Texas
Dallas
Dallas, Texas, United States, 75244
United States, Virginia
Fredericksburg
Fredericksburg, Virginia, United States, 22412
Virginia Beach
Virginia Beach, Virginia, United States, 23454
Sponsors and Collaborators
Physicians Committee for Responsible Medicine
Investigators
Principal Investigator: Neal Barnard, M.D. Washington Center for Clinical Research
  More Information

No publications provided

Responsible Party: Physicians Committee for Responsible Medicine
ClinicalTrials.gov Identifier: NCT01224548     History of Changes
Other Study ID Numbers: WCCR-WNS2
Study First Received: August 30, 2010
Last Updated: January 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Physicians Committee for Responsible Medicine:
vegan
diet
diabetes
overweight
workplace
nutrition
diabetes and/or overweight

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

ClinicalTrials.gov processed this record on August 21, 2014