Impact of a Diabetes Risk Score on Lifestyle Education and Patient Adherence

Pre-diabetes Clinical Trial

— IDEA  

Official title:

Impact of a Diabetes Risk Score on Lifestyle Education and Patient Adherence (IDEA Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01932866
• Other study ID #: IDEA Trial
• Status: Completed
• Phase: N/A
• First received: August 21, 2013
• Last updated: August 27, 2013
• Start date: June 2010
• Est. completion date: June 2013

Study information

• Verified date: August 2013
• Source: Wilford Hall Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this randomized, controlled study is to evaluate whether the knowledge of a personalized diabetes risk score affects adherence to a 12-week diet and exercise lifestyle change program in prediabetic patients. The intervention group will receive diabetes risk score results at the beginning of the twelve weeks, and the control group will not receive these results. Both groups will review their baseline and 12-week diabetes risk score results at the conclusion of the program and will be followed for an additional twelve weeks. Attendance rates and changes in weight, BMI, abdominal circumference, blood pressure, HgA1c, fasting blood glucose, cholesterol, and diabetes risk score will be compared between the groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• Men and women of all ethnic groups

• =30 -75 years of age

• Pre-diabetic defined as follows: fasting plasma glucose (FPG) 100-125mg/dL, HbA1c 5.7% to 6.4%.

• Body Mass Index = 25 kg/m2

• Tricare beneficiary

Exclusion Criteria:

Diagnosis of type 1 or type 2 diabetes mellitus (defined as FPG =126 mg/dl on two different occasions or random blood sugar =200) If fasting glucose >= 126 only once, a second lab does not need to be arranged in an attempt to diagnose diabetes. It is acceptable for the patient to proceed in the trial. Also, Tethys lab results (e.g., fasting glucose and A1C) should not be used to make decisions about including or excluding patients in the trial. Only Air Force lab results should be used to make this determination.

• Active duty military members

• Patients with untreated hypothyroidism or previously diagnosed Cushing's syndrome

• Subjects previously treated with metformin or thiazolidinediones in the previous 12 months

• Psychological or physical disabilities deemed likely to interfere with participation in the study

• Patients currently using weight-loss medications or medications known to affect body weight (i.e. chronic corticosteroid use)

• Major medical conditions that prevent participation in the Group Lifestyle Balance Prevention Program (i.e. severe cardiovascular or cerebrovascular disease, severe renal or liver dysfunction, etc.)

• Concurrent participation in a different weight loss program

• Previous bariatric surgery

• Unwilling to agree with the study assignments or provide informed consent

• Participation in any other research project that would interfere with this protocol

• Unable to read and write English

• Pregnant or nursing patients

• Female patients unwilling to undergo a pregnancy test or report possible pregnancy promptly and unwilling to take precautions to avoid pregnancy if potentially fertile during the study course

Discontinuation Criteria:

• Consent is withdrawn

• Death occurs

• A woman becomes pregnant

• Severe impairment of manual dexterity, vision, or intellectual function

• They become lost to follow-up because of a move or transfer outside of the geographic area

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Risk Score
• Glucose Intolerance
• Motivation
• Pre-diabetes
• Prediabetic State

Intervention

Other:
• diabetic risk score

Locations

Country	Name	City	State
United States	Andrews Military Medical Center	Andrews AFB	Maryland
United States	Wilford Hall Ambulatory Surgical Center	Lackland AFB	Texas
United States	Nellis Family Medicine	Nellis AFB	Nevada
United States	David Grant Medical Center	Travis AFB	California
United States	Wright Patterson Medical Center	Wright Patterson AFB	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Wilford Hall Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attendance rates	Attendance rates (percentage of subjects attending the classes) of the two groups will be compared.	6 months	No
Primary	Change in weight	change in weight from baseline to 12 weeks and 24 weeks will be compared between groups.	baseline, 12 weeks, 24 weeks	No
Primary	Change in BMI	change in BMI from baseline to 12 weeks and 24 weeks will be compared between groups.	baseline, 12 weeks, 24 weeks	No
Primary	Change in abdominal circumference	change in abdominal circumference from baseline to 12 weeks and 24 weeks will be compared between groups.	baseline, 12 weeks, 24 weeks	No
Secondary	Change in blood pressure	change in blood pressure from baseline to 12 weeks and 24 weeks will be compared between groups.	baseline, 12 weeks, 24 weeks	No
Secondary	Change in HgA1c	change in HgA1c from baseline to 12 weeks and 24 weeks will be compared between groups.	baseline, 12 weeks, 24 weeks	No
Secondary	Change in fasting blood glucose	change in fasting blood glucose from baseline to 12 weeks and 24 weeks will be compared between groups.	baseline, 12 weeks, 24 weeks	No
Secondary	Change in cholesterol	change in cholesterol from baseline to 12 weeks and 24 weeks will be compared between groups.	baseline, 12 weeks, 24 weeks	No
Secondary	Change in diabetes risk score	change in diabetes risk score from baseline to 12 weeks and 24 weeks will be compared between groups.	baseline, 12 weeks, and 24 weeks	No