The Meal Tray as a Tool and Platform to Change Eating Hab... | NCT00845793

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

NCT00845793

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Feb 18, 2009Estimated

Enrollment

500Estimated

Phase

Not Applicable

Conditions

Type 2 Diabetes

Interventions

Nutritional guidance

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Dec 2011Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Feb 16, 2009

First Submission Date that Met QC Criteria

Feb 17, 2009

First Posted Date

Feb 18, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2009

Last Update Posted Date

Feb 18, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nutritional guidance	Behavioral	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).

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Center		Jerusalem		91120	Israel

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided