Multicenter Worksite Nutrition Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

292 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-10-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Diabetes Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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vegan group

participants from sites of this group will receive vegan nutritional intervention starting from Feb 2011

Group Type EXPERIMENTAL

vegan instruction and food accessibility

Intervention Type OTHER

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

control

Intervention Type OTHER

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

control group

participants from sites of the control group will not receive the same nutritional information until June 2011

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

control

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No