Pre-diabetesIDEANCT01932866
Impact of a Diabetes Risk Score on Lifestyle Education and Patient Adherence
A study testing diabetic risk score in people with Pre-diabetes and Diabetes Risk Score, run by 59th Medical Wing at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Pre-diabetes, Diabetes Risk Score, Motivation
- What is being tested?
- diabetic risk score
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2010to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Andrews Military Medical Center
Andrews Air Force Base, Maryland, 20762
Wilford Hall Ambulatory Surgical Center
Lackland Air Force Base, Texas, 78236
Nellis Family Medicine
Nellis Air Force Base, Nevada, 89191
David Grant Medical Center
Travis AFB, California, 94535
Wright Patterson Medical Center
Wright-Patterson AFB, Ohio, 45324
About this study
Official title: Impact of a Diabetes Risk Score on Lifestyle Education and Patient Adherence (IDEA Trial)
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
- Being tested
- diabetic risk score
- Keywords
- pre-diabetes, diabetes risk score, motivation, Air Force, Military, Lifestyle change
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diabetic risk scoreOther
| Study group | Role | What they receive |
|---|---|---|
| Control - diabetes risk score | Active comparator | 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. Receives: Other: diabetic risk score |
| Intervention - diabetes risk score | Experimental | the subjects in the intervention arm received their diabetes risk scores at the beginning of the trial, 12 weeks and 24 weeks. Receives: Other: diabetic risk score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance rates
Attendance rates (percentage of subjects attending the classes) of the two groups will be compared.
Measured: 6 months
Change in weight
change in weight from baseline to 12 weeks and 24 weeks will be compared between groups.
Measured: baseline, 12 weeks, 24 weeks
Change in BMI
change in BMI from baseline to 12 weeks and 24 weeks will be compared between groups.
Measured: baseline, 12 weeks, 24 weeks
Change in abdominal circumference
change in abdominal circumference from baseline to 12 weeks and 24 weeks will be compared between groups.
Measured: baseline, 12 weeks, 24 weeks
Secondary outcomes (5)
Change in blood pressure
change in blood pressure from baseline to 12 weeks and 24 weeks will be compared between groups.
Measured: baseline, 12 weeks, 24 weeks
Change in HgA1c
change in HgA1c from baseline to 12 weeks and 24 weeks will be compared between groups.
Measured: baseline, 12 weeks, 24 weeks
Change in fasting blood glucose
change in fasting blood glucose from baseline to 12 weeks and 24 weeks will be compared between groups.
Measured: baseline, 12 weeks, 24 weeks
Change in cholesterol
change in cholesterol from baseline to 12 weeks and 24 weeks will be compared between groups.
Measured: baseline, 12 weeks, 24 weeks
Change in diabetes risk score
change in diabetes risk score from baseline to 12 weeks and 24 weeks will be compared between groups.
Measured: baseline, 12 weeks, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startJun 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- 59th Medical Wing
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Mark True, MD, 59th Medical Wing
- Investigators
- Mark W True, MD, Principal investigator, US Air Force
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932866
- Sponsor's protocol ID
- IDEA Trial
- Acronym
- IDEA
- Status last verified
- Aug 2013
- First submitted
- 21 Aug 2013
- Last updated
- 30 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Diabetes Risk Score on Lifestyle Education and Patient Adherence (IDEA Trial)
- ClinicalTrials.gov ID
- NCT01932866
- Acronym / sponsor ID
- IDEA / IDEA Trial
- Conditions
- Pre-diabetes, Diabetes Risk Score, Motivation
- Keywords
- pre-diabetes, diabetes risk score, motivation, Air Force, Military, Lifestyle change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- 59th Medical WingUS federal agency
- Study start
- Jun 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 30 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control - diabetes risk score | Active comparator | Other: diabetic risk scorethe 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. |
| Intervention - diabetes risk score | Experimental | Other: diabetic risk scorethe subjects in the intervention arm received their diabetes risk scores at the beginning of the trial, 12 weeks and 24 weeks. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diabetic risk score | Other | Control - diabetes risk score, Intervention - diabetes risk score |
Primary outcome
Attendance rates
Time frame: 6 months
Attendance rates (percentage of subjects attending the classes) of the two groups will be compared.
Change in weight
Time frame: baseline, 12 weeks, 24 weeks
change in weight from baseline to 12 weeks and 24 weeks will be compared between groups.
Change in BMI
Time frame: baseline, 12 weeks, 24 weeks
change in BMI from baseline to 12 weeks and 24 weeks will be compared between groups.
Change in abdominal circumference
Time frame: baseline, 12 weeks, 24 weeks
change in abdominal circumference from baseline to 12 weeks and 24 weeks will be compared between groups.
5 secondary outcomes
Change in blood pressure
Time frame: baseline, 12 weeks, 24 weeks
Change in HgA1c
Time frame: baseline, 12 weeks, 24 weeks
Change in fasting blood glucose
Time frame: baseline, 12 weeks, 24 weeks
Change in cholesterol
Time frame: baseline, 12 weeks, 24 weeks
Change in diabetes risk score
Time frame: baseline, 12 weeks, and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark W True, MD principal investigator
US Air Force
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diabetic risk score in people with Pre-diabetes and Diabetes Risk Score, run by 59th Medical Wing at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance rates (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2013.