OverweightNCT00481897
Worksite Nutrition Study
A study testing low-fat, vegan diet in people with Overweight and Type 2 Diabetes, run by Physicians Committee for Responsible Medicine at 1 site in United States.
Trial summary
The Worksite Nutrition Study is 22-week translational study aimed at determining how well a worksite-based nutrition program, as compared to a control group, is able to 1) produce clinically significant weight-loss, 2) improve cardiovascular factors, 3) decrease work absenteeism, 4) improve overall quality of life, 5)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight, Type 2 Diabetes
- What is being tested?
- low-fat, vegan diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jul 2008
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- employee at the intervention worksite or the control worksite;
- BMI > 25 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 with the use of hypoglycemic medications for at least six months;
- male or female;
- age at least 18 years;
- ability and willingness to participate in all components of the study; and
- a willingness to be assigned to a low-fat, vegan diet or control group.
Who cannot join
- a history of alcohol abuse or dependency followed by any current use;
- current or unresolved past drug abuse;
- pregnancy;
- history of severe mental illness;
- unstable medical status;
- already following a low-fat, vegetarian diet;
- an inordinate fear of blood draw; and
- A1c <7 or >10.5% (for volunteers with diabetes).
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Center for Clinical Research
Washington D.C., District of Columbia, 20016
About this study
The Worksite Nutrition Study is 22-week translational study aimed at determining how well a worksite-based nutrition program, as compared to a control group, is able to 1) produce clinically significant weight-loss, 2) improve cardiovascular factors, 3) decrease work absenteeism, 4) improve overall quality of life, 5) improve diabetes control in participants with diabetes, and 6) promote dietary adherence and acceptability. The nutrition program for the intervention group consists of once-weekly group meetings where participants will receive group support and nutrition education on a low-fat, vegan diet.
Read the detailed description
Approximately 65 percent of Americans are overweight or obese. They are at increased risk for diabetes, hypertension, dyslipidemia, cardiovascular disease, arthritis, respiratory disorders, pregnancy complications, and premature death. Research has demonstrated that weight status is associated with certain types of malignancies, including endometrial, colon, gall bladder, prostate, kidney, and postmenopausal breast cancer. The total direct and indirect costs attributed to overweight and obesity amounted to 117 billion U.S. dollars in 2000.
The 22-week Worksite Nutrition Study will (1) test whether a worksite intervention, which prescribes a low-fat vegan diet, is effective in promoting clinically significant weight loss, (2) evaluate whether the intervention reduces cardiovascular risk, particularly blood pressure and lipid concentrations, (3) assess whether the intervention improves glycemic control in individuals with type 2 diabetes, and (4) examine how the intervention affects work impairment and absenteeism.
Participants (Group 1, n=60) at a specified worksite will be assigned to the diet intervention program, which prescribes a low-fat, vegan diet. A control group (Group 2, n=60) will be designated at a separate worksite. The participants in the control group will not receive an active intervention during the designated study period. Participants in the active intervention will attend weekly group meetings for nutrition education on the intervention diet.
Diets will be assessed, in order to monitor adherence and for the purposes of comparison, in the intervention and control groups at baseline and at weeks 11 and 22 using a 3-day dietary record. Dependent measures, including body weight, blood pressure, lipid concentrations, quality-of-life measures, and A1c (for those with diabetes) will be assessed in the intervention and control groups at weeks 0, 11, and 22.
- Conditions
- Overweight, Type 2 Diabetes
- Being tested
- low-fat, vegan diet
- Keywords
- overweight, obesity, type 2 diabetes, diabetes, worksite cost, nutrition
- Medical subject headings
- Overweight, Diabetes Mellitus, Type 2, Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-fat, vegan dietBehavioural
Diet that excludes animal products (i.e. meat, dairy, eggs) and keeps oils to a minimum.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assignment to a diet intervention program promotes clinically significant weight loss, compared to a control group.
Measured: 22 weeks
Assignment to the diet intervention program improves indices of cardiovascular risk, including plasma lipid concentrations and blood pressure, compared to a control group.
Measured: 22 weeks
Assignment to the diet intervention program improves glycemia in a sub-group of participants with type 2 diabetes, as indicated by mean A1c, relative to matched participants with type 2 diabetes in the control group.
Measured: 22 weeks
Assignment to the diet intervention, decreases the prevalence of work absenteeism, as measured by the proportion of days that a participant is absent from work, compared with assignment to a control group.
Measured: 22 weeks
Secondary outcomes (2)
Assignment to the diet intervention improves quality of life measures, including general mental and physical health, relative to assignment to a control group.
Measured: 22 weeks
Assignment to the diet intervention program promotes adherence and acceptability.
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2007 (estimated)
- Study startMay 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Physicians Committee for Responsible Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hope Ferdowsian, M.D., M.P.H., Principal investigator, Washington Center for Clinical ResearchNeal Barnard, M.D., Principal investigator, Washington Center for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00481897
- Sponsor's protocol ID
- WCCR-07065-01
- Status last verified
- Aug 2012
- First submitted
- 31 May 2007
- Last updated
- 7 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Levin SM, Ferdowsian HR, Hoover VJ, Green AA, Barnard ND. A worksite programme significantly alters nutrient intakes. Public Health Nutr. 2010 Oct;13(10):1629-35. doi: 10.1017/S136898000999303X. Epub 2010 Jan 15.
PubMed 20074388Katcher HI, Ferdowsian HR, Hoover VJ, Cohen JL, Barnard ND. A worksite vegan nutrition program is well-accepted and improves health-related quality of life and work productivity. Ann Nutr Metab. 2010;56(4):245-52. doi: 10.1159/000288281. Epub 2010 Apr 14.
PubMed 20389060Ferdowsian HR, Barnard ND, Hoover VJ, Katcher HI, Levin SM, Green AA, Cohen JL. A multicomponent intervention reduces body weight and cardiovascular risk at a GEICO corporate site. Am J Health Promot. 2010 Jul-Aug;24(6):384-7. doi: 10.4278/ajhp.081027-QUAN-255.
PubMed 20594095
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Worksite Nutrition Study
- ClinicalTrials.gov ID
- NCT00481897
- Acronym / sponsor ID
- WCCR-07065-01
- Conditions
- Overweight, Type 2 Diabetes
- Keywords
- overweight, obesity, type 2 diabetes, diabetes, worksite cost, nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Physicians Committee for Responsible MedicineUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 4 Jun 2007 (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 Worksite Nutrition Study is 22-week translational study aimed at determining how well a worksite-based nutrition program, as compared to a control group, is able to 1) produce clinically significant weight-loss, 2) improve cardiovascular factors, 3) decrease work absenteeism, 4) improve overall quality of life, 5) improve diabetes control in participants with diabetes, and 6) promote dietary adherence and acceptability. The nutrition program for the intervention group consists of once-weekly group meetings where participants will receive group support and nutrition education on a low-fat, vegan diet.
Detailed description
Approximately 65 percent of Americans are overweight or obese. They are at increased risk for diabetes, hypertension, dyslipidemia, cardiovascular disease, arthritis, respiratory disorders, pregnancy complications, and premature death. Research has demonstrated that weight status is associated with certain types of malignancies, including endometrial, colon, gall bladder, prostate, kidney, and postmenopausal breast cancer. The total direct and indirect costs attributed to overweight and obesity amounted to 117 billion U.S. dollars in 2000.
The 22-week Worksite Nutrition Study will (1) test whether a worksite intervention, which prescribes a low-fat vegan diet, is effective in promoting clinically significant weight loss, (2) evaluate whether the intervention reduces cardiovascular risk, particularly blood pressure and lipid concentrations, (3) assess whether the intervention improves glycemic control in individuals with type 2 diabetes, and (4) examine how the intervention affects work impairment and absenteeism.
Participants (Group 1, n=60) at a specified worksite will be assigned to the diet intervention program, which prescribes a low-fat, vegan diet. A control group (Group 2, n=60) will be designated at a separate worksite. The participants in the control group will not receive an active intervention during the designated study period. Participants in the active intervention will attend weekly group meetings for nutrition education on the intervention diet.
Diets will be assessed, in order to monitor adherence and for the purposes of comparison, in the intervention and control groups at baseline and at weeks 11 and 22 using a 3-day dietary record. Dependent measures, including body weight, blood pressure, lipid concentrations, quality-of-life measures, and A1c (for those with diabetes) will be assessed in the intervention and control groups at weeks 0, 11, and 22.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- employee at the intervention worksite or the control worksite;
- BMI > 25 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 with the use of hypoglycemic medications for at least six months;
- male or female;
- age at least 18 years;
- ability and willingness to participate in all components of the study; and
Key exclusion criteria (8 listed)
- a history of alcohol abuse or dependency followed by any current use;
- current or unresolved past drug abuse;
- pregnancy;
- history of severe mental illness;
- unstable medical status;
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 |
|---|---|---|
| low-fat, vegan dietDiet that excludes animal products (i.e. meat, dairy, eggs) and keeps oils to a minimum. | Behavioural | – |
Primary outcome
Assignment to a diet intervention program promotes clinically significant weight loss, compared to a control group.
Time frame: 22 weeks
Assignment to the diet intervention program improves indices of cardiovascular risk, including plasma lipid concentrations and blood pressure, compared to a control group.
Time frame: 22 weeks
Assignment to the diet intervention program improves glycemia in a sub-group of participants with type 2 diabetes, as indicated by mean A1c, relative to matched participants with type 2 diabetes in the control group.
Time frame: 22 weeks
Assignment to the diet intervention, decreases the prevalence of work absenteeism, as measured by the proportion of days that a participant is absent from work, compared with assignment to a control group.
Time frame: 22 weeks
2 secondary outcomes
Assignment to the diet intervention improves quality of life measures, including general mental and physical health, relative to assignment to a control group.
Time frame: 22 weeks
Assignment to the diet intervention program promotes adherence and acceptability.
Time frame: 22 weeks
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 7 Aug 2012.
- Results publication: PubMed 20074388Levin SM, Ferdowsian HR, Hoover VJ, Green AA, Barnard ND. A worksite programme significantly alters nutrient intakes. Public Health Nutr. 2010 Oct;13(10):1629-35. doi: 10.1017/S136898000999303X. Epub 2010 Jan 15.
- Results publication: PubMed 20389060Katcher HI, Ferdowsian HR, Hoover VJ, Cohen JL, Barnard ND. A worksite vegan nutrition program is well-accepted and improves health-related quality of life and work productivity. Ann Nutr Metab. 2010;56(4):245-52. doi: 10.1159/000288281. Epub 2010 Apr 14.
- Results publication: PubMed 20594095Ferdowsian HR, Barnard ND, Hoover VJ, Katcher HI, Levin SM, Green AA, Cohen JL. A multicomponent intervention reduces body weight and cardiovascular risk at a GEICO corporate site. Am J Health Promot. 2010 Jul-Aug;24(6):384-7. doi: 10.4278/ajhp.081027-QUAN-255.
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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.
Hope Ferdowsian, M.D., M.P.H. principal investigator
Washington Center for Clinical Research
Neal Barnard, M.D. principal investigator
Washington Center for Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-fat, vegan diet in people with Overweight and Type 2 Diabetes, run by Physicians Committee for Responsible Medicine at 1 site 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 8 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 7 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Assignment to a diet intervention program promotes clinically significant weight loss, compared to a control group. (time frame: 22 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00481897, which also lists 3 linked publications.
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 7 Aug 2012.