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

Primary Purpose

Pre-diabetes, Diabetes Risk Score, Motivation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
diabetic risk score
Sponsored by
59th Medical Wing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre-diabetes focused on measuring pre-diabetes, diabetes risk score, motivation, Air Force, Military, Lifestyle change

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • David Grant Medical Center
  • Andrews Military Medical Center
  • Nellis Family Medicine
  • Wright Patterson Medical Center
  • Wilford Hall Ambulatory Surgical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control - diabetes risk score

Intervention - diabetes risk score

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Attendance rates
Attendance rates (percentage of subjects attending the classes) of the two groups will be compared.
Change in weight
change in weight from baseline to 12 weeks and 24 weeks will be compared between groups.
Change in BMI
change in BMI from baseline to 12 weeks and 24 weeks will be compared between groups.
Change in abdominal circumference
change in abdominal circumference from baseline to 12 weeks and 24 weeks will be compared between groups.

Secondary Outcome Measures

Change in blood pressure
change in blood pressure from baseline to 12 weeks and 24 weeks will be compared between groups.
Change in HgA1c
change in HgA1c from baseline to 12 weeks and 24 weeks will be compared between groups.
Change in fasting blood glucose
change in fasting blood glucose from baseline to 12 weeks and 24 weeks will be compared between groups.
Change in cholesterol
change in cholesterol from baseline to 12 weeks and 24 weeks will be compared between groups.
Change in diabetes risk score
change in diabetes risk score from baseline to 12 weeks and 24 weeks will be compared between groups.

Full Information

First Posted
August 21, 2013
Last Updated
August 27, 2013
Sponsor
59th Medical Wing
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1. Study Identification

Unique Protocol Identification Number
NCT01932866
Brief Title
Impact of a Diabetes Risk Score on Lifestyle Education and Patient Adherence
Acronym
IDEA
Official Title
Impact of a Diabetes Risk Score on Lifestyle Education and Patient Adherence (IDEA Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
59th Medical Wing

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-diabetes, Diabetes Risk Score, Motivation
Keywords
pre-diabetes, diabetes risk score, motivation, Air Force, Military, Lifestyle change

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
223 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control - diabetes risk score
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intervention - diabetes risk score
Arm Type
Experimental
Arm Description
the subjects in the intervention arm received their diabetes risk scores at the beginning of the trial, 12 weeks and 24 weeks.
Intervention Type
Other
Intervention Name(s)
diabetic risk score
Primary Outcome Measure Information:
Title
Attendance rates
Description
Attendance rates (percentage of subjects attending the classes) of the two groups will be compared.
Time Frame
6 months
Title
Change in weight
Description
change in weight from baseline to 12 weeks and 24 weeks will be compared between groups.
Time Frame
baseline, 12 weeks, 24 weeks
Title
Change in BMI
Description
change in BMI from baseline to 12 weeks and 24 weeks will be compared between groups.
Time Frame
baseline, 12 weeks, 24 weeks
Title
Change in abdominal circumference
Description
change in abdominal circumference from baseline to 12 weeks and 24 weeks will be compared between groups.
Time Frame
baseline, 12 weeks, 24 weeks
Secondary Outcome Measure Information:
Title
Change in blood pressure
Description
change in blood pressure from baseline to 12 weeks and 24 weeks will be compared between groups.
Time Frame
baseline, 12 weeks, 24 weeks
Title
Change in HgA1c
Description
change in HgA1c from baseline to 12 weeks and 24 weeks will be compared between groups.
Time Frame
baseline, 12 weeks, 24 weeks
Title
Change in fasting blood glucose
Description
change in fasting blood glucose from baseline to 12 weeks and 24 weeks will be compared between groups.
Time Frame
baseline, 12 weeks, 24 weeks
Title
Change in cholesterol
Description
change in cholesterol from baseline to 12 weeks and 24 weeks will be compared between groups.
Time Frame
baseline, 12 weeks, 24 weeks
Title
Change in diabetes risk score
Description
change in diabetes risk score from baseline to 12 weeks and 24 weeks will be compared between groups.
Time Frame
baseline, 12 weeks, and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark W True, MD
Organizational Affiliation
US Air Force
Official's Role
Principal Investigator
Facility Information:
Facility Name
David Grant Medical Center
City
Travis AFB
State/Province
California
ZIP/Postal Code
94535
Country
United States
Facility Name
Andrews Military Medical Center
City
Andrews AFB
State/Province
Maryland
ZIP/Postal Code
20762
Country
United States
Facility Name
Nellis Family Medicine
City
Nellis AFB
State/Province
Nevada
ZIP/Postal Code
89191
Country
United States
Facility Name
Wright Patterson Medical Center
City
Wright Patterson AFB
State/Province
Ohio
ZIP/Postal Code
45324
Country
United States
Facility Name
Wilford Hall Ambulatory Surgical Center
City
Lackland AFB
State/Province
Texas
ZIP/Postal Code
78236
Country
United States

12. IPD Sharing Statement

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

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