The Meal Tray as a Tool and Platform to Change Eating Habits Among Hospitalized Diabetic Patients - An Intervention Study
Primary Purpose
Type 2 Diabetes
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Nutritional guidance
Sponsored by
About this trial
This is an interventional health services research trial for Type 2 Diabetes focused on measuring Type 2 diabetes, Nutrition, Lifestyle modifications
Eligibility 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
Sites / Locations
- Hadassah Medical Center
Outcomes
Primary Outcome Measures
Changes in the results of the nutrition quality questionnaire
Secondary Outcome Measures
Changes in anthropometric measures Changes in physical activity levels
Full Information
NCT ID
NCT00845793
First Posted
February 16, 2009
Last Updated
February 17, 2009
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT00845793
Brief Title
The Meal Tray as a Tool and Platform to Change Eating Habits Among Hospitalized Diabetic Patients - An Intervention Study
Official Title
The Meal Tray as a Tool and Platform to Change Eating Habits Among Hospitalized Diabetic Patients - An Intervention Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 diabetes, Nutrition, Lifestyle modifications
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Nutritional guidance
Intervention Description
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 Measure Information:
Title
Changes in the results of the nutrition quality questionnaire
Time Frame
3 and 12 months
Secondary Outcome Measure Information:
Title
Changes in anthropometric measures Changes in physical activity levels
Time Frame
3 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ram Weiss, MD PhD
12. IPD Sharing Statement
Learn more about this trial
The Meal Tray as a Tool and Platform to Change Eating Habits Among Hospitalized Diabetic Patients - An Intervention Study
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