Status:

COMPLETED

Multicenter Worksite Nutrition Study

Lead Sponsor:

Physicians Committee for Responsible Medicine

Conditions:

Diabetes

Overweight

Eligibility:

All Genders

18-70 years

Phase:

NA

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 ...

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 workpl...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2011

Estimated Enrollment :

292 Patients enrolled

Trial Details

Trial ID

NCT01224548

Start Date

October 1 2010

End Date

October 1 2011

Last Update

January 24 2013

Active Locations (10)

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Page 1 of 3 (10 locations)

1

Tucson

Tucson, Arizona, United States, 85710

2

San Diego

San Diego, California, United States, 92064

3

Lakeland

Lakeland, Florida, United States, 33811

4

Macon

Macon, Georgia, United States, 31295