The Meal Tray as a Tool and Platform to Change Eating Habits Among Hospitalized Diabetic Patients - An Intervention Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00845793
Recruitment Status : Unknown
Verified February 2009 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : February 18, 2009
Last Update Posted : February 18, 2009
Information provided by:
Hadassah Medical Organization

Brief Summary:

This protocol is intended to test whether a focused nutritional intervention in hospitalized patients with type 2 diabetes can have an impact on long term eating habits, physical activity and anthropometric parameters.

The rational is to use the food tray as a means of conveying simple and practical nutritonal and behavioral messages.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Nutritional guidance Not Applicable

Detailed Description:

Patients hospitalized at Hadassah Medical Center who have type 2 diabetes will relieve a focused nutritional intervention using mainly the food tray during the hospitalization. The intervention will be administered by the hospital nutrition team.

At baseline (upon admission) - medical data will be collected as well as nutritional and behavioral questionnaires will be administered. The intervention will take place during the hospitalization period. Follow up using the same tools will be performed at 3 and 12 month.

We believe that the hospitalization period, even for reasons non related to diabetes, is a window of opportunity to implement lifestyle changes.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Meal Tray as a Tool and Platform to Change Eating Habits Among Hospitalized Diabetic Patients - An Intervention Study
Study Start Date : April 2009
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Behavioral: Nutritional guidance
    The guidance will be performed using the food tray during the hospitalization and will consist of meeting the nutritionist and receiving brochures along with the meal tray focusing on constituents and elements of the diet. The served meals will consist of elements recommended for patients with T2DM (such as whole grains, low fat dairy products and canola oil).

Primary Outcome Measures :
  1. Changes in the results of the nutrition quality questionnaire [ Time Frame: 3 and 12 months ]

Secondary Outcome Measures :
  1. Changes in anthropometric measures Changes in physical activity levels [ Time Frame: 3 and 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 20-80 years
  • Diagnosis of type 2 diabetes
  • Speaking and reading Hebrew

Exclusion Criteria:

  • Chronic medical condition requiring a specific diet
  • Non Hebrew speaking
  • Pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00845793

Hadassah Medical Center Not yet recruiting
Jerusalem, Israel, 91120
Principal Investigator: Ram Weiss, MD PhD         
Sponsors and Collaborators
Hadassah Medical Organization

Responsible Party: Ram Weiss MD PhD, Hadassah Medical Organization Identifier: NCT00845793     History of Changes
Other Study ID Numbers: HMO- 0584-08
First Posted: February 18, 2009    Key Record Dates
Last Update Posted: February 18, 2009
Last Verified: February 2009

Keywords provided by Hadassah Medical Organization:
Type 2 diabetes
Lifestyle modifications

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases