Clinical trial NCT01932866: Impact of a Diabetes Risk Score on Lifestyle Education and Patient Adherence
Official title: Impact of a Diabetes Risk Score on Lifestyle Education and Patient Adherence (IDEA Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-diabetes
Diabetes Risk Score
Motivation
Keywords: pre-diabetes
diabetes risk score
motivation
Air Force
Military
Lifestyle change
Lead sponsor: 59th Medical Wing
Sponsor class: FED
First posted: 2013-08-30
Enrollment: 223
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Attendance rates
timeFrame: 6 months
measure: Change in weight
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change in BMI
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change in abdominal circumference
timeFrame: baseline, 12 weeks, 24 weeks
Secondary outcomes:
measure: Change in blood pressure
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change in HgA1c
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change in fasting blood glucose
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change in cholesterol
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change in diabetes risk score
timeFrame: baseline, 12 weeks, and 24 weeks
Other outcomes:
Locations:
city: Travis AFB
country: United States
facility: David Grant Medical Center
state: California
city: Andrews AFB
country: United States
facility: Andrews Military Medical Center
state: Maryland
city: Nellis AFB
country: United States
facility: Nellis Family Medicine
state: Nevada
city: Wright Patterson AFB
country: United States
facility: Wright Patterson Medical Center
state: Ohio
city: Lackland AFB
country: United States
facility: Wilford Hall Ambulatory Surgical Center
state: Texas
Study officials:
affiliation: US Air Force
name: Mark W True, MD
role: PRINCIPAL_INVESTIGATOR
References: