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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00573482
Other study ID # DK02-021 (completed)
Secondary ID 5R01HL073775
Status Completed
Phase N/A
First received December 12, 2007
Last updated February 24, 2010
Start date September 2002
Est. completion date February 2007

Study information

Verified date February 2010
Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The dramatic rise in overweight and obesity during the past several decades can be explained by environmental changes that foster increased energy intake and decreased energy expenditure. There are several reasons to suggest that the most effective approach to weight gain prevention is the incorporate reduced-fat eating into an overall strategy of lowering the energy density of the diet. Our energy density manipulations will be designed to reduce both the fat content and the caloric density of foods served at a cafeteria, which serves as the "food environment" for hospital employees.


Recruitment information / eligibility

Status Completed
Enrollment 106
Est. completion date February 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 65 Years
Eligibility Inclusion Criteria:

- works at one of the two hospitals and eats lunch in the cafeteria 2x per week

- BMI between 23 and 25

Exclusion Criteria:

- current diagnosis of a chronic disease or condition known to affect appetite or body weight

- currently taking medication known to affect appetite or body weight

- current pregnancy or plans to become pregnant within the next 24 months

- current enrollment or plans to enroll within the next 24 months in an organized weight management program

- plans to terminate employment at the hospital within the next 12 months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
REDE
The intervention group received the education in REDE techniques. The intervention in this study comprised four components: Four group education sessions to introduce the REDE principles of eating; Approximately 10 new lower energy-dense foods were introduced in the employee cafeteria daily at lunchtime; Food labels for all foods sold in the employee cafeteria at lunch time, which provided the energy density, calories, and macronutrient content of the prepared cafeteria foods. Prior to the intervention almost no foods had food labels. Price reductions for lower energy density items. Both groups were exposed to the food labels and the new lower ED foods, but only the intervention group received the education sessions about how to take advantage of the new labels and cafeteria foods and only they were eligible for the price reductions.
control
The control group received no REDE intervention at all. Both groups were exposed to the food labels and the new lower ED foods, but the control group did not receive the education sessions.

Locations

Country Name City State
United States Local Hospitals Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weight 36 months No
Secondary Caloric and macro-nutrient intake 36 months No
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