Worksite Nutrition Study

NCT00481897 | Completed DMC

• 1 other identifier: WCCR-07065-01
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief 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) 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.

Conditions

Overweight; Type 2 Diabetes

Keywords

overweight; obesity; type 2 diabetes; diabetes; worksite cost; nutrition

Outcome Measures

Primary Outcomes (4)

• Assignment to a diet intervention program promotes clinically significant weight loss, compared to a control group.

  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.

  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.

  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.

  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.

  22 weeks

• Assignment to the diet intervention program promotes adherence and acceptability.

  22 weeks

Interventions

low-fat, vegan diet BEHAVIORAL

Diet that excludes animal products (i.e. meat, dairy, eggs) and keeps oils to a minimum.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Physicians Committee for Responsible Medicine: lead

Study Sites (1)

Washington Center for Clinical Research

Washington D.C., District of Columbia, 20016, United States

Location

Related Publications (3)

• 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.

  PMID: 20074388 RESULT

• Katcher 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.

  PMID: 20389060 RESULT

• Ferdowsian 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.

  PMID: 20594095 RESULT

MeSH Terms

Conditions

Overweight; Diabetes Mellitus, Type 2; Obesity; Diabetes Mellitus

Interventions

Diet, Fat-Restricted; Diet, Vegan

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Diet, Vegetarian; Diet, Plant-Based

Study Officials

• Hope Ferdowsian, M.D., M.P.H.

  Washington Center for Clinical Research

  PRINCIPAL INVESTIGATOR

• Neal Barnard, M.D.

  Washington Center for Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2007
• First Posted: June 4, 2007
• Study Start: May 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: August 7, 2012

Record last verified: 2012-08

Locations

US (1)