Clinical trial NCT01224548: Multicenter Worksite Nutrition Study
Official title: Multicenter Worksite Nutrition Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Overweight
Keywords: vegan
diet
diabetes
overweight
workplace
nutrition
diabetes and/or overweight
Lead sponsor: Physicians Committee for Responsible Medicine
Sponsor class: OTHER
First posted: 2010-10-20
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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 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

Primary outcomes:
measure: weight
timeFrame: 0 months
measure: weight
timeFrame: 18 weeks
measure: weight
timeFrame: 10 months
Secondary outcomes:
measure: blood pressure
timeFrame: 0 months
measure: blood pressure
timeFrame: 18 weeks
measure: blood pressure
timeFrame: 10 months
measure: waist circumference
timeFrame: 0 month
measure: waist circumference
timeFrame: 18 weeks
measure: waist circumference
timeFrame: 10 months
measure: absenteeism
timeFrame: 0 month
measure: absenteeism
timeFrame: 18 weeks
measure: absenteeism
timeFrame: 10 months
measure: health insurance utilization
timeFrame: 0 month
measure: healthy insurance utilization
timeFrame: 12 months
measure: blood lipid panel
timeFrame: 0 month
measure: blood lipid panel
timeFrame: 18 weeks
measure: blood lipid panel
timeFrame: 10 months
measure: quality of life
timeFrame: 0 month
measure: quality of life
timeFrame: 18 weeks
measure: quality of life
timeFrame: 10 months
measure: hemoglobin A1c
timeFrame: 0 month
measure: hemoglobin A1c
timeFrame: 18 weeks
measure: hemoglobin A1c
timeFrame: 10 months
measure: hip circumference
timeFrame: 0 month
measure: hip circumference
timeFrame: 18 weeks
measure: hip circumference
timeFrame: 10 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Tucson
state: Arizona
city: San Diego
country: United States
facility: San Diego
state: California
city: Lakeland
country: United States
facility: Lakeland
state: Florida
city: Macon
country: United States
facility: Macon
state: Georgia
city: Chevy Chase
country: United States
facility: Chevy Chase
state: Maryland
city: Buffalo
country: United States
facility: Buffalo
state: New York
city: Woodbury
country: United States
facility: Woodbury
state: New York
city: Dallas
country: United States
facility: Dallas
state: Texas
city: Fredericksburg
country: United States
facility: Fredericksburg
state: Virginia
city: Virginia Beach
country: United States
facility: Virginia Beach
state: Virginia
Study officials:
affiliation: Washington Center for Clinical Research
name: Neal Barnard, M.D.
role: PRINCIPAL_INVESTIGATOR
References: