NCT00845793

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Apr 2009

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 18, 2009

Status Verified

February 1, 2009

Enrollment Period

2.7 years

First QC Date

February 16, 2009

Last Update Submit

February 17, 2009

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetesNutritionLifestyle modifications

Outcome Measures

Primary Outcomes (1)

  • Changes in the results of the nutrition quality questionnaire

    3 and 12 months

Secondary Outcomes (1)

  • Changes in anthropometric measures Changes in physical activity levels

    3 and 12 months

Interventions

Nutritional guidanceBEHAVIORAL

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).

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 20-80 years
  • Diagnosis of type 2 diabetes
  • Speaking and reading Hebrew

You may not qualify if:

  • Chronic medical condition requiring a specific diet
  • Non Hebrew speaking
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 16, 2009

First Posted

February 18, 2009

Study Start

April 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

February 18, 2009

Record last verified: 2009-02

Locations

IL(1)