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Cardiovascular DiseasesNCT00142662

Cafeteria-Based Study of Weight Gain Prevention

A study testing diet and financial incentives in people with Cardiovascular Diseases and Heart Diseases, run by Drexel University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To investigate two cafeteria-based methods of weight gain prevention in overweight men and women. Read more about this study

Who is it for?
Ages 21 to 65 years
Conditions the study is for
Cardiovascular Diseases, Heart Diseases, Obesity
What is being tested?
diet and financial incentives
How many people
Not given
Where
No sites listed yet
Study dates
Sep 2002to Aug 2005
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
  • No healthy volunteers
  • Adult, Older adult

No eligibility criteria

About this study

To investigate two cafeteria-based methods of weight gain prevention in overweight men and women.

Read the detailed description

BACKGROUND:

Obesity is a risk factor for a number of adverse medical and psychosocial outcomes. Solving the obesity problem will require a much greater emphasis on prevention. Treatment research indicates that interventions focusing directly on the food environment (structured meals and control of food stimuli) have considerable promise for weight control. Prevention research has found little support for trying to modify characteristics (e.g., knowledge, beliefs, skills) of individuals, perhaps because this approach does little to modify the food environment. The research will be implemented in a workplace cafeteria where employees eat year-round and where the nutritional composition of the food can be modified.

The study was initiated in response to a Request for Applications issued in October, 2001 on "Environmental Approaches to the Prevention of Obesity". The Request for Applications was jointly issued by the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Environmental Health Sciences, the National Center for Minority Health and Health Disparities, the Office of Behavioral and Social Sciences Research, and the National Heart, Lung, and Blood Institute.

DESIGN NARRATIVE:

The influence of two promising interventions on food intake, weight change, and related outcomes will be investigated. The first intervention consists of a training program aimed at reducing the energy density of participants' diets inside and outside of the cafeteria. The second intervention consists of financial incentives to encourage the consumption of cafeteria foods lower in energy density. Participants will be 195 Caucasian and African-American men and women between the ages of 21 and 65. They will have a BMI of 23-35 and will have characteristics associated with an increased risk of weight gain. Selection and intake of lunch foods will be measured with digital photography and cashiers' computerized records of food purchases. Cafeteria patrons will be randomly assigned to 1) a measurement-only condition; 2) an intervention designed to teach participants how to reduce the energy density of their diets; or 3) the reduced energy density intervention plus financial incentives for choosing cafeteria foods low in energy density. The potential moderating influence of individual differences characteristics on outcome will also be evaluated. Outcome measures will be administered repeatedly during the intervention and at 9- and 18-month follow-ups. The assessments will include measures of anthropomorphic and blood lipid variables, nutritional intake (both in and out of the cafeteria), physical activity, overeating, eating self-efficacy, and weight-related quality of life.

Being tested
diet, financial incentives
Medical subject headings
Cardiovascular Diseases, Heart Diseases, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dietBehavioural

  • financial incentivesBehavioural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2005 (estimated)
  2. Study startSep 2002
  3. Primary completionAug 2005
  4. Study completionAug 2005

Resources

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
IDs, dates and publications
ClinicalTrials.gov ID
NCT00142662
Sponsor's protocol ID
252
Other IDs
R01HL073775
Status last verified
Jan 2008
First submitted
1 Sep 2005
Last updated
27 Mar 2014
Results posted
No

Publications

  • Lowe MR, Levine AS. Eating motives and the controversy over dieting: eating less than needed versus less than wanted. Obes Res. 2005 May;13(5):797-806. doi: 10.1038/oby.2005.90.

    PubMed 15919830

Questions about this trial

What is this clinical trial studying?

A study testing diet and financial incentives in people with Cardiovascular Diseases and Heart Diseases, run by Drexel University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 27 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00142662, which also lists 1 linked publication.

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 27 Mar 2014.

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