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

NCT ID: NCT01932866

Last Updated: 2013-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 223 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2013-06-30

Brief 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.

Conditions

Pre-diabetes; Diabetes Risk Score; Motivation

Keywords

pre-diabetes; diabetes risk score; motivation; Air Force; Military; Lifestyle change

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control - diabetes risk score

the participants in the control group did not receive their diabetes risk score at the beginning of the trial, but did receive their scores to include baseline at the 12 and 24 week points.

Group Type: ACTIVE_COMPARATOR

diabetic risk score

Intervention Type: OTHER

Intervention - diabetes risk score

the subjects in the intervention arm received their diabetes risk scores at the beginning of the trial, 12 weeks and 24 weeks.

Group Type: EXPERIMENTAL

diabetic risk score

Intervention Type: OTHER

Interventions

diabetic risk score

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

59th Medical Wing

FED

Sponsor Role: lead

Responsible Party

Mark True, MD

Program Director, Endocrinology Fellowship

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark W True, MD

Role: PRINCIPAL_INVESTIGATOR

US Air Force

Locations

David Grant Medical Center

Travis AFB, California, United States

Andrews Military Medical Center

Andrews Air Force Base Census Designated Place, Maryland, United States

Nellis Family Medicine

Nellis Air Force Base, Nevada, United States

Wright Patterson Medical Center

Wright-Patterson AFB, Ohio, United States

Wilford Hall Ambulatory Surgical Center

Lackland Air Force Base, Texas, United States

Countries

United States

Other Identifiers

IDEA Trial

Identifier Type: -

Identifier Source: org_study_id