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

August 30, 2010
January 23, 2013
October 2010
June 2011   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01224548 on ClinicalTrials.gov Archive Site
  • 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
  • blood pressure [ Time Frame: 0 months ] [ Designated as safety issue: No ]
    diastolic and systolic blood pressures at baseline
  • blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    diastolic and systolic blood pressures at the end of 6 months
  • blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    diastolic and systolic blood pressures at the end of 12 months
  • blood pressure [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    diastolic and systolic blood pressures at the end of 24 months
  • waist circumference [ Time Frame: 0 month ] [ Designated as safety issue: No ]
    measurement of waist circumference at baseline
  • waist circumference [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    measurement of waist circumference at 6 months
  • waist circumference [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    measurement of waist circumference at 12 months
  • waist circumference [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    measurement of waist circumference at 24 months
  • Food Acceptability [ Time Frame: 0 month ] [ Designated as safety issue: No ]
    Questionnaire about Food intake at baseline
  • Food Acceptability [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Questionnaire about Food intake at 6 months
  • Food Acceptability [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Questionnaire about Food intake at 12 months
  • Food Acceptability [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Questionnaire about Food intake at 24 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: 6 months ] [ Designated as safety issue: No ]
    number of days absent because of sickness over the past 6 months, surveyed at the end of 6 months.
  • absenteeism [ Time Frame: 12 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.
  • absenteeism [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    number of days absent because of sickness over the past 6 months, surveyed at the end of 24 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
  • healthy insurance utilization [ Time Frame: 24 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 24 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: 6 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 6 months
  • blood lipid panel [ Time Frame: 12 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
  • blood lipid panel [ Time Frame: 24 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 24 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: 6 months ] [ Designated as safety issue: No ]
    questionnaire on quality of life measurements surveyed at the end of 6 months
  • quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    questionnaire on quality of life measurements surveyed at the end of 12 months
  • quality of life [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    questionnaire on quality of life measurements surveyed at the end of 24 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: 6 months ] [ Designated as safety issue: No ]
    blood test of hemoglobin A1c level (for diabetic participants only) at the end of 6 months
  • hemoglobin A1c [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    blood test of hemoglobin A1c level (for diabetic participants only) at the end of 12 months
  • hemoglobin A1c [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    blood test of hemoglobin A1c level (for diabetic participants only) at the end of 24 months
  • hip circumference [ Time Frame: 0 month ] [ Designated as safety issue: No ]
    measurement of hip circumference at baseline
  • hip circumference [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    measurement of hip circumference at the end of 6 months
  • hip circumference [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    measurement of hip circumference at the end of 12 months
  • hip circumference [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    measurement of hip circumference at the end of 24 months
Not Provided
Not Provided
 
Multicenter Worksite Nutrition Study
Multicenter Worksite Nutrition Study

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Diabetes
  • Overweight
  • 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.
  • Experimental: vegan group
    participants from sites of this group will receive vegan nutritional intervention starting from Feb 2011
    Interventions:
    • Other: vegan instruction and food accessibility
    • Other: control
  • No Intervention: control group
    participants from sites of the control group will not receive the same nutritional information until June 2011
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
292
October 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01224548
WCCR-WNS2
Yes
Physicians Committee for Responsible Medicine
Physicians Committee for Responsible Medicine
Not Provided
Principal Investigator: Neal Barnard, M.D. Washington Center for Clinical Research
Physicians Committee for Responsible Medicine
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP