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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00481897 |
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Date of registration:
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31/05/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Worksite Nutrition Study
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Scientific title:
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Worksite Nutrition Study |
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Date of first enrolment:
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May 2007 |
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Target sample size:
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113 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00481897 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Hope Ferdowsian, M.D., M.P.H. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Washington Center for Clinical Research |
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Name:
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Neal Barnard, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Washington Center for Clinical Research |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Overweight
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Type 2 Diabetes
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Intervention(s)
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Behavioral: low-fat, vegan diet
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Primary Outcome(s)
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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]
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Assignment to a diet intervention program promotes clinically significant weight loss, compared to a control group.
[Time Frame: 22 weeks]
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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]
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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]
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Secondary Outcome(s)
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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]
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Assignment to the diet intervention program promotes adherence and acceptability.
[Time Frame: 22 weeks]
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Secondary ID(s)
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WCCR-07065-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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