vegan instruction and food accessibility
Otherweekly 1-hr instructions including vegan nutritional information and cooking instructions. vegan menu will be made available at the cafeteria
NCT Number: NCT01224548
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.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Tucson, Arizona, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
weekly 1-hr instructions including vegan nutritional information and cooking instructions. vegan menu will be made available at the cafeteria
no intervention in until June 2011. The control group start vegan diet in July 2011.
Time frame: 0 months
body weight at baseline
Time frame: 18 weeks
body weight at the end of 4 months
Time frame: 10 months
body weight at the end of 12 months
Time frame: 0 months
diastolic and systolic blood pressures at baseline
Time frame: 18 weeks
diastolic and systolic blood pressures at the end of 4 months
Time frame: 10 months
diastolic and systolic blood pressures at the end of 12 months
Time frame: 0 month
measurement of waist circumference at baseline
Time frame: 18 weeks
measurement of waist circumference at 4 months
Time frame: 10 months
measurement of waist circumference at 12 months
Time frame: 0 month
number of days absent because of sickness over the past 6 months, surveyed at baseline
Time frame: 18 weeks
number of days absent because of sickness over the past 4 months, surveyed at the end of 4 months.
Time frame: 10 months
number of days absent because of sickness over the past 6 months, surveyed at the end of 12 months.
Time frame: 0 month
categorized payments by health insurance company for health-related coverage over the past 12 months, surveyed at baseline
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
Time frame: 0 month
blood test of Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), total cholesterol, and triglyceride at baseline
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
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
Time frame: 0 month
questionnaire on quality of life measurements surveyed at baseline
Time frame: 18 weeks
questionnaire on quality of life measurements surveyed at the end of 4 months
Time frame: 10 months
questionnaire on quality of life measurements surveyed at the end of 12 months
Time frame: 0 month
blood test of hemoglobin A1c level (for diabetic participants only) at baseline
Time frame: 18 weeks
blood test of hemoglobin A1c level (for diabetic participants only) at the end of 4 months
Time frame: 10 months
blood test of hemoglobin A1c level (for diabetic participants only) at the end of 12 months
Time frame: 0 month
measurement of hip circumference at baseline
Time frame: 18 weeks
measurement of hip circumference at the end of 4 months
Time frame: 10 months
measurement of hip circumference at the end of 12 months
Physicians Committee for Responsible Medicine
Other
Acronym: WNS2
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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.
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