- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00573482
A Cafeteria Based Study of Weight Gain Prevention (Cafeteria)
February 24, 2010 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
106
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States
- Local Hospitals
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: control group
Control (only exposure to the food labels and the new lower ED foods).
|
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.
|
Experimental: intervention group
Education in REDE techniques plus exposure to the food labels and the new lower ED foods.
|
The intervention group received the education in REDE techniques. The intervention in this study comprised four components:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Weight
Time Frame: 36 months
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Caloric and macro-nutrient intake
Time Frame: 36 months
|
36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2002
Study Completion (Actual)
February 1, 2007
Study Registration Dates
First Submitted
December 12, 2007
First Submitted That Met QC Criteria
December 13, 2007
First Posted (Estimate)
December 14, 2007
Study Record Updates
Last Update Posted (Estimate)
February 25, 2010
Last Update Submitted That Met QC Criteria
February 24, 2010
Last Verified
February 1, 2010
More Information
Terms related to this study
Keywords
- obesity
- overweight
- weight gain prevention
- food environment
- The intervention group received the education in REDE techniques
- The control group received no intervention at all.
- Both groups were exposed to the food labels and the new lower ED foods.
- Only the intervention group received the education sessions and only they were eligible for the price reductions.
Additional Relevant MeSH Terms
Other Study ID Numbers
- DK02-021 (completed)
- 5R01HL073775 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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