Multicenter Worksite Nutrition Study

Diabetes Clinical Trial

— WNS2  

Official title:

Multicenter Worksite Nutrition Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224548
• Other study ID #: WCCR-WNS2
• Status: Completed
• Phase: N/A
• First received: August 30, 2010
• Last updated: January 23, 2013
• Start date: October 2010
• Est. completion date: October 2011

Study information

• Verified date: January 2013
• Source: Physicians Committee for Responsible Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 292
• Est. completion date: October 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes
• Overweight

Intervention

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

Locations

Country	Name	City	State
United States	Buffalo	Buffalo	New York
United States	Chevy Chase	Chevy Chase	Maryland
United States	Dallas	Dallas	Texas
United States	Fredericksburg	Fredericksburg	Virginia
United States	Lakeland	Lakeland	Florida
United States	Macon	Macon	Georgia
United States	San Diego	San Diego	California
United States	Tucson	Tucson	Arizona
United States	Virginia Beach	Virginia Beach	Virginia
United States	Woodbury	Woodbury	New York

Sponsors (1)

Lead Sponsor	Collaborator
Physicians Committee for Responsible Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight	body weight at baseline	0 months	No
Primary	weight	body weight at the end of 4 months	18 weeks	No
Primary	weight	body weight at the end of 12 months	10 months	No
Secondary	blood pressure	diastolic and systolic blood pressures at baseline	0 months	No
Secondary	blood pressure	diastolic and systolic blood pressures at the end of 4 months	18 weeks	No
Secondary	blood pressure	diastolic and systolic blood pressures at the end of 12 months	10 months	No
Secondary	waist circumference	measurement of waist circumference at baseline	0 month	No
Secondary	waist circumference	measurement of waist circumference at 4 months	18 weeks	No
Secondary	waist circumference	measurement of waist circumference at 12 months	10 months	No
Secondary	absenteeism	number of days absent because of sickness over the past 6 months, surveyed at baseline	0 month	No
Secondary	absenteeism	number of days absent because of sickness over the past 4 months, surveyed at the end of 4 months.	18 weeks	No
Secondary	absenteeism	number of days absent because of sickness over the past 6 months, surveyed at the end of 12 months.	10 months	No
Secondary	health insurance utilization	categorized payments by health insurance company for health-related coverage over the past 12 months, surveyed at baseline	0 month	No
Secondary	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	12 months	No
Secondary	blood lipid panel	blood test of Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), total cholesterol, and triglyceride at baseline	0 month	No
Secondary	blood lipid panel	blood test of Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), total cholesterol, and triglyceride at the end of 4 months	18 weeks	No
Secondary	blood lipid panel	blood test of Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), total cholesterol, and triglyceride at the end of 12 months	10 months	No
Secondary	quality of life	questionnaire on quality of life measurements surveyed at baseline	0 month	No
Secondary	quality of life	questionnaire on quality of life measurements surveyed at the end of 4 months	18 weeks	No
Secondary	quality of life	questionnaire on quality of life measurements surveyed at the end of 12 months	10 months	No
Secondary	hemoglobin A1c	blood test of hemoglobin A1c level (for diabetic participants only) at baseline	0 month	No
Secondary	hemoglobin A1c	blood test of hemoglobin A1c level (for diabetic participants only) at the end of 4 months	18 weeks	No
Secondary	hemoglobin A1c	blood test of hemoglobin A1c level (for diabetic participants only) at the end of 12 months	10 months	No
Secondary	hip circumference	measurement of hip circumference at baseline	0 month	No
Secondary	hip circumference	measurement of hip circumference at the end of 4 months	18 weeks	No
Secondary	hip circumference	measurement of hip circumference at the end of 12 months	10 months	No