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

February 17, 2009 updated by: Hadassah Medical Organization

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Medical Center
        • Principal Investigator:
          • Ram Weiss, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in the results of the nutrition quality questionnaire
Time Frame: 3 and 12 months
3 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in anthropometric measures Changes in physical activity levels
Time Frame: 3 and 12 months
3 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

February 16, 2009

First Submitted That Met QC Criteria

February 17, 2009

First Posted (Estimate)

February 18, 2009

Study Record Updates

Last Update Posted (Estimate)

February 18, 2009

Last Update Submitted That Met QC Criteria

February 17, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMO- 0584-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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