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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
  Purpose

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 Intervention
Type 2 Diabetes
 Behavioral: Nutritional guidance

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Changes in the results of the nutrition quality questionnaire [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in anthropometric measures Changes in physical activity levels [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: April 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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).
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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845793

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

No publications provided

Responsible Party: Ram Weiss MD PhD, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00845793     History of Changes
Other Study ID Numbers: HMO- 0584-08
Study First Received: February 16, 2009
Last Updated: February 17, 2009
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 22, 2013