ObesityCafeteriaNCT00573482
A Cafeteria Based Study of Weight Gain Prevention
A study testing REDE in people with Obesity and Overweight, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- REDE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Feb 2007
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- works at one of the two hospitals and eats lunch in the cafeteria 2x per week
- BMI between 23 and 25
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Obesity, Overweight
- Being tested
- REDE, control
- Keywords
- weight gain prevention, obesity, overweight, 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.
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REDEBehavioural
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.
controlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Control (only exposure to the food labels and the new lower ED foods). Receives: Behavioral: control |
| intervention group | Experimental | Education in REDE techniques plus exposure to the food labels and the new lower ED foods. Receives: Behavioral: REDE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measured: 36 months
Secondary outcomes (1)
Caloric and macro-nutrient intake
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startSep 2002
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Michael R Lowe, Ph.D., Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573482
- Sponsor's protocol ID
- DK02-021 (completed)
- Other IDs
- 5R01HL073775
- Acronym
- Cafeteria
- Status last verified
- Feb 2010
- First submitted
- 12 Dec 2007
- Last updated
- 25 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cafeteria Based Study of Weight Gain Prevention
- ClinicalTrials.gov ID
- NCT00573482
- Acronym / sponsor ID
- Cafeteria / DK02-021 (completed)
- Conditions
- Obesity, Overweight
- Keywords
- weight gain prevention, obesity, overweight, 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.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Sep 2002
- Study completion
- Feb 2007 (actual)
- First posted
- 14 Dec 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 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Behavioral: controlControl (only exposure to the food labels and the new lower ED foods). |
| intervention group | Experimental | Behavioral: REDEEducation in REDE techniques plus exposure to the food labels and the new lower ED foods. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- works at one of the two hospitals and eats lunch in the cafeteria 2x per week
- BMI between 23 and 25
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| REDEThe 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. | Behavioural | intervention group |
| controlThe 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. | Behavioural | control group |
Primary outcome
Weight
Time frame: 36 months
1 secondary outcome
Caloric and macro-nutrient intake
Time frame: 36 months
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 25 Feb 2010.
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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.
Michael R Lowe, Ph.D. principal investigator
Drexel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REDE in people with Obesity and Overweight, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 2 inclusion and 5 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 25 Feb 2010. 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?
Weight (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2010.