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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2009 by Hadassah Medical Organization.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Hadassah Medical Organization

ClinicalTrials.gov Identifier:

NCT00845793

First received: February 16, 2009

Last updated: February 17, 2009

Last verified: February 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	February 16, 2009
Last Updated Date	February 17, 2009
Start Date ^ICMJE	April 2009
Estimated Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 17, 2009)	Changes in the results of the nutrition quality questionnaire [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00845793 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 17, 2009)	Changes in anthropometric measures Changes in physical activity levels [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Meal Tray as a Tool and Platform to Change Eating Habits Among Hospitalized Diabetic Patients - An Intervention Study
Official Title ^ICMJE	The Meal Tray as a Tool and Platform to Change Eating Habits Among Hospitalized Diabetic Patients - An Intervention Study
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.
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 ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research
Condition ^ICMJE	Type 2 Diabetes
Intervention ^ICMJE	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).
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	500
Estimated Completion Date	December 2011
Estimated Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	20 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT00845793
Other Study ID Numbers ^ICMJE	HMO- 0584-08
Has Data Monitoring Committee	No
Responsible Party	Ram Weiss MD PhD, Hadassah Medical Organization
Study Sponsor ^ICMJE	Hadassah Medical Organization
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Hadassah Medical Organization
Verification Date	February 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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