NCT01224548

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
292

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Oct 2010

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 20, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

8 months

First QC Date

August 30, 2010

Last Update Submit

January 23, 2013

Conditions

DiabetesOverweight

Keywords

vegandietdiabetesoverweightworkplacenutritiondiabetes and/or overweight

Outcome Measures

Primary Outcomes (3)

  • weight

    body weight at baseline

    0 months

  • weight

    body weight at the end of 4 months

    18 weeks

  • weight

    body weight at the end of 12 months

    10 months

Secondary Outcomes (23)

  • blood pressure

    0 months

  • blood pressure

    18 weeks

  • blood pressure

    10 months

  • waist circumference

    0 month

  • waist circumference

    18 weeks

  • +18 more secondary outcomes

Study Arms (2)

vegan group

EXPERIMENTAL

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

Other: vegan instruction and food accessibilityOther: control

control group

NO INTERVENTION

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

Interventions

vegan instruction and food accessibilityOTHER

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

vegan group
controlOTHER

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

vegan group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Tucson

Tucson, Arizona, 85710, United States

Location

San Diego

San Diego, California, 92064, United States

Location

Lakeland

Lakeland, Florida, 33811, United States

Location

Macon

Macon, Georgia, 31295, United States

Location

Chevy Chase

Chevy Chase, Maryland, 20815, United States

Location

Buffalo

Buffalo, New York, 14068, United States

Location

Woodbury

Woodbury, New York, 11797, United States

Location

Dallas

Dallas, Texas, 75244, United States

Location

Fredericksburg

Fredericksburg, Virginia, 22412, United States

Location

Virginia Beach

Virginia Beach, Virginia, 23454, United States

Location

MeSH Terms

Conditions

Diabetes MellitusOverweight

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Neal Barnard, M.D.

    Washington Center for Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2010

First Posted

October 20, 2010

Study Start

October 1, 2010

Primary Completion

June 1, 2011

Study Completion

October 1, 2011

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

US(10)