Skip to main content
OpenTrials
Completed

NCT Number: NCT01224548

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tucson, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vegan instruction and food accessibility

Other

weekly 1-hr instructions including vegan nutritional information and cooking instructions. vegan menu will be made available at the cafeteria

Control

Other

no intervention in until June 2011. The control group start vegan diet in July 2011.

Primary outcomes

  1. weight

    Time frame: 0 months

    body weight at baseline

  2. weight

    Time frame: 18 weeks

    body weight at the end of 4 months

  3. weight

    Time frame: 10 months

    body weight at the end of 12 months

Secondary outcomes

  1. blood pressure

    Time frame: 0 months

    diastolic and systolic blood pressures at baseline

  2. blood pressure

    Time frame: 18 weeks

    diastolic and systolic blood pressures at the end of 4 months

  3. blood pressure

    Time frame: 10 months

    diastolic and systolic blood pressures at the end of 12 months

  4. waist circumference

    Time frame: 0 month

    measurement of waist circumference at baseline

  5. waist circumference

    Time frame: 18 weeks

    measurement of waist circumference at 4 months

  6. waist circumference

    Time frame: 10 months

    measurement of waist circumference at 12 months

  7. absenteeism

    Time frame: 0 month

    number of days absent because of sickness over the past 6 months, surveyed at baseline

  8. absenteeism

    Time frame: 18 weeks

    number of days absent because of sickness over the past 4 months, surveyed at the end of 4 months.

  9. absenteeism

    Time frame: 10 months

    number of days absent because of sickness over the past 6 months, surveyed at the end of 12 months.

  10. health insurance utilization

    Time frame: 0 month

    categorized payments by health insurance company for health-related coverage over the past 12 months, surveyed at baseline

  11. healthy insurance utilization

    Time frame: 12 months

    categorized payments by health insurance company for health-related coverage over the past 12 months, surveyed at the end of 12 months

  12. blood lipid panel

    Time frame: 0 month

    blood test of Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), total cholesterol, and triglyceride at baseline

  13. blood lipid panel

    Time frame: 18 weeks

    blood test of Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), total cholesterol, and triglyceride at the end of 4 months

  14. blood lipid panel

    Time frame: 10 months

    blood test of Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), total cholesterol, and triglyceride at the end of 12 months

  15. quality of life

    Time frame: 0 month

    questionnaire on quality of life measurements surveyed at baseline

  16. quality of life

    Time frame: 18 weeks

    questionnaire on quality of life measurements surveyed at the end of 4 months

  17. quality of life

    Time frame: 10 months

    questionnaire on quality of life measurements surveyed at the end of 12 months

  18. hemoglobin A1c

    Time frame: 0 month

    blood test of hemoglobin A1c level (for diabetic participants only) at baseline

  19. hemoglobin A1c

    Time frame: 18 weeks

    blood test of hemoglobin A1c level (for diabetic participants only) at the end of 4 months

  20. hemoglobin A1c

    Time frame: 10 months

    blood test of hemoglobin A1c level (for diabetic participants only) at the end of 12 months

  21. hip circumference

    Time frame: 0 month

    measurement of hip circumference at baseline

  22. hip circumference

    Time frame: 18 weeks

    measurement of hip circumference at the end of 4 months

  23. hip circumference

    Time frame: 10 months

    measurement of hip circumference at the end of 12 months

Sponsors and collaborators

Lead sponsor

Physicians Committee for Responsible Medicine

Other

Registry information

Acronym: WNS2

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 20, 2010
Registry last updated
Jan 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.