DiabetesWNS2NCT01224548
Multicenter Worksite Nutrition Study
A study testing vegan instruction and food accessibility in people with Diabetes and Overweight, run by Physicians Committee for Responsible Medicine at 10 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes, Overweight
- What is being tested?
- vegan instruction and food accessibility
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 10 sitesUnited States
- Study dates
- Oct 2010to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Already following a low-fat, vegetarian diet
- An inordinate fear of blood draws
- Previously participated in GEICO two site study
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Buffalo
Buffalo, New York, 14068
Chevy Chase
Chevy Chase, Maryland, 20815
Dallas
Dallas, Texas, 75244
Fredericksburg
Fredericksburg, Virginia, 22412
Lakeland
Lakeland, Florida, 33811
Macon
Macon, Georgia, 31295
San Diego
San Diego, California, 92064
Tucson
Tucson, Arizona, 85710
Virginia Beach
Virginia Beach, Virginia, 23454
Woodbury
Woodbury, New York, 11797
About this study
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.
Read the 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.
- Conditions
- Diabetes, Overweight
- Being tested
- vegan instruction and food accessibility, control
- Keywords
- vegan, diet, diabetes, overweight, workplace, nutrition, diabetes and/or overweight
- Medical subject headings
- Diabetes Mellitus, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
controlOther
no intervention in until June 2011. The control group start vegan diet in July 2011.
| Study group | Role | What they receive |
|---|---|---|
| vegan group | Experimental | participants from sites of this group will receive vegan nutritional intervention starting from Feb 2011 Receives: Other: vegan instruction and food accessibility; Other: control |
| control group | No intervention | participants from sites of the control group will not receive the same nutritional information until June 2011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight
body weight at baseline
Measured: 0 months
weight
body weight at the end of 4 months
Measured: 18 weeks
weight
body weight at the end of 12 months
Measured: 10 months
Secondary outcomes (23)
blood pressure
diastolic and systolic blood pressures at baseline
Measured: 0 months
blood pressure
diastolic and systolic blood pressures at the end of 4 months
Measured: 18 weeks
blood pressure
diastolic and systolic blood pressures at the end of 12 months
Measured: 10 months
waist circumference
measurement of waist circumference at baseline
Measured: 0 month
waist circumference
measurement of waist circumference at 4 months
Measured: 18 weeks
waist circumference
measurement of waist circumference at 12 months
Measured: 10 months
absenteeism
number of days absent because of sickness over the past 6 months, surveyed at baseline
Measured: 0 month
absenteeism
number of days absent because of sickness over the past 4 months, surveyed at the end of 4 months.
Measured: 18 weeks
absenteeism
number of days absent because of sickness over the past 6 months, surveyed at the end of 12 months.
Measured: 10 months
health insurance utilization
categorized payments by health insurance company for health-related coverage over the past 12 months, surveyed at baseline
Measured: 0 month
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
Measured: 12 months
blood lipid panel
blood test of Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), total cholesterol, and triglyceride at baseline
Measured: 0 month
blood lipid panel
blood test of Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), total cholesterol, and triglyceride at the end of 4 months
Measured: 18 weeks
blood lipid panel
blood test of Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), total cholesterol, and triglyceride at the end of 12 months
Measured: 10 months
quality of life
questionnaire on quality of life measurements surveyed at baseline
Measured: 0 month
quality of life
questionnaire on quality of life measurements surveyed at the end of 4 months
Measured: 18 weeks
quality of life
questionnaire on quality of life measurements surveyed at the end of 12 months
Measured: 10 months
hemoglobin A1c
blood test of hemoglobin A1c level (for diabetic participants only) at baseline
Measured: 0 month
hemoglobin A1c
blood test of hemoglobin A1c level (for diabetic participants only) at the end of 4 months
Measured: 18 weeks
hemoglobin A1c
blood test of hemoglobin A1c level (for diabetic participants only) at the end of 12 months
Measured: 10 months
hip circumference
measurement of hip circumference at baseline
Measured: 0 month
hip circumference
measurement of hip circumference at the end of 4 months
Measured: 18 weeks
hip circumference
measurement of hip circumference at the end of 12 months
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Physicians Committee for Responsible Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neal Barnard, M.D., Principal investigator, Washington Center for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224548
- Sponsor's protocol ID
- WCCR-WNS2
- Acronym
- WNS2
- Status last verified
- Jan 2013
- First submitted
- 30 Aug 2010
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Worksite Nutrition Study
- ClinicalTrials.gov ID
- NCT01224548
- Acronym / sponsor ID
- WNS2 / WCCR-WNS2
- Conditions
- Diabetes, Overweight
- Keywords
- vegan, diet, diabetes, overweight, workplace, nutrition, diabetes and/or overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Physicians Committee for Responsible MedicineUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 20 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vegan group | Experimental | Other: vegan instruction and food accessibility, Other: controlparticipants from sites of this group will receive vegan nutritional intervention starting from Feb 2011 |
| control group | No intervention | –participants from sites of the control group will not receive the same nutritional information until June 2011 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vegan instruction and food accessibilityweekly 1-hr instructions including vegan nutritional information and cooking instructions. vegan menu will be made available at the cafeteria | Other | vegan group |
| controlno intervention in until June 2011. The control group start vegan diet in July 2011. | Other | vegan group |
Primary outcome
weight
Time frame: 0 months
body weight at baseline
weight
Time frame: 18 weeks
body weight at the end of 4 months
weight
Time frame: 10 months
body weight at the end of 12 months
23 secondary outcomes
blood pressure
Time frame: 0 months
blood pressure
Time frame: 18 weeks
blood pressure
Time frame: 10 months
waist circumference
Time frame: 0 month
waist circumference
Time frame: 18 weeks
waist circumference
Time frame: 10 months
absenteeism
Time frame: 0 month
absenteeism
Time frame: 18 weeks
absenteeism
Time frame: 10 months
health insurance utilization
Time frame: 0 month
healthy insurance utilization
Time frame: 12 months
blood lipid panel
Time frame: 0 month
blood lipid panel
Time frame: 18 weeks
blood lipid panel
Time frame: 10 months
quality of life
Time frame: 0 month
quality of life
Time frame: 18 weeks
quality of life
Time frame: 10 months
hemoglobin A1c
Time frame: 0 month
hemoglobin A1c
Time frame: 18 weeks
hemoglobin A1c
Time frame: 10 months
hip circumference
Time frame: 0 month
hip circumference
Time frame: 18 weeks
hip circumference
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neal Barnard, M.D. principal investigator
Washington Center for Clinical Research
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vegan instruction and food accessibility in people with Diabetes and Overweight, run by Physicians Committee for Responsible Medicine at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight (time frame: 0 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013.