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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00845793
• Other study ID #: HMO- 0584-08
• Status: Not yet recruiting
• Phase: N/A
• First received: February 16, 2009
• Last updated: February 17, 2009
• Start date: April 2009
• Est. completion date: December 2011

Study information

• Verified date: February 2009
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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).

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the results of the nutrition quality questionnaire		3 and 12 months	No
Secondary	Changes in anthropometric measures Changes in physical activity levels		3 and 12 months	No