NCT00198913

Brief Summary

Part 1 of this research demonstrated that type II diabetics are lacking in knowledge of how to best treat their illness with dietary controls. Most had little nutrition or diabetes knowledge. Part 2 demonstrated that providing a 40% reduction in fat intake across three meals versus all at one meal was more effective in glycemic control. Part 3 is designed to incorporate these findings into a long-term free living setting through education and behavior/dietary modification.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Jun 2002

Shorter than P25 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

September 20, 2005

Status Verified

April 1, 2003

First QC Date

September 13, 2005

Last Update Submit

September 13, 2005

Conditions

Type 2 Diabetes MellitusObesity

Outcome Measures

Primary Outcomes (2)

  • blood glucose control

  • weight

Secondary Outcomes (2)

  • body composition

  • psychometrics

Interventions

lower fat food supplied and educationBEHAVIORAL
gift cards for grocery foods and written educationBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 2 diabetic, age 18 and over, informed consent,

You may not qualify if:

  • type 1 diabetic or non-diabetic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Lutherville, Maryland, 21093, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Lawrence J Cheskin, MD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

June 1, 2002

Study Completion

February 1, 2003

Last Updated

September 20, 2005

Record last verified: 2003-04

Locations

US(1)