Pre-DiabetesNCT00853801
Integrating Lifestyle Therapy for Diabetes Prevention Into Primary Care
A study testing Lifestyle intervention and provider feedback in people with Pre-Diabetes and Metabolic Syndrome, run by Cook County Health at 1 site in United States.
Trial summary
An educational intervention in the General Medicine Clinic aimed at both primary care providers (PCPs) and their patients with metabolic syndrome/pre-diabetes (MetSyn/PDM). Improving PCPs ability to detect and manage MetSyn/PDM, as measured by the increased incorporation of MetSyn/PDM into PCPs care plan, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pre-Diabetes, Metabolic Syndrome, Type 2 Diabetes
- What is being tested?
- Lifestyle intervention and provider feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Dec 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has metabolic syndrome as defined by three or more of the five risk factors:
- elevated blood pressure (BP) above 130 mm Hg systolic and/or 85 mm Hg diastolic or drug therapy for elevated blood pressure
- elevated waist circumference (WC)above 35" (female) or above 40" (male)
- reduced high-density lipoprotein (HDL) of below 40 mg/dl (male) or below 50 mg/dl (female) or drug therapy for reduced HDL
- elevated triglycerides (TG) of 150 mg/dl or above or drug therapy for elevated TG
- elevated fasting blood glucose (FBG) of 100 mg/dl and above and below 126 mg/dl)or pre-diabetes as defined as elevated FBG.
- Has a primary care provider in the General Medicine Clinic (GMC).
Who cannot join
- Has been diagnosed with any of the following:
- diabetes
- known CAD (MI, CABG, PTCA)
- congestive Heart Failure NYHA Class III or IV
- Life expectancy less than 2 years
- Non-English speaking patient
- Patient whose physician is a PGY-3 resident, graduating before projected completion of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detecting and Managing Metabolic Syndrome and Pre-Diabetes in General Medicine Clinic (Feasibility)
An educational intervention in the General Medicine Clinic aimed at both primary care providers (PCPs) and their patients with metabolic syndrome/pre-diabetes (MetSyn/PDM). Improving PCPs ability to detect and manage MetSyn/PDM, as measured by the increased incorporation of MetSyn/PDM into PCPs care plan, and increasing patients' awareness of healthy lifestyle behaviors results in positive patient health behaviors and outcomes.
Read the detailed description
The highest diabetes prevalence in the US is among African Americans (13.3%), American Indians (12.8%), and Mexican Americans (9.5%) with 8.7% of European Americans diagnosed with diabetes. In addition, certain minorities also have much higher rates of diabetes-related complications and death, in some instances by as much as 50% more than the general population, highlighting that the greatest need for preventive measures are amongst ethnic minorities.
The efficacy of lifestyle intervention in reducing the incidence of type 2 diabetes has been established by the Diabetes Prevention Program and other studies. The Cook County Bureau of Health Services, a publicly-funded healthcare system serving a primarily low-income, uninsured, ethnically diverse population in Chicago, IL, currently treats an estimated 40,000 patients annually for type 2 diabetes and estimates that another 85,000 to 100,000 patients are at risk for developing diabetes.
Our primary objective was to test the feasibility of integrating less intensive lifestyle intervention therapy into patient visits with their primary care provider to improve weight loss and decrease the intensity of metabolic syndrome and pre-diabetes risk factors. The site of the study is the General Medicine Clinic, a busy primary care outpatient site treating approximately 12,000 patients/year and 200 patients/day, staffed primarily by medical residents supervised by attending physicians.
- Conditions
- Pre-Diabetes, Metabolic Syndrome, Type 2 Diabetes
- Being tested
- Lifestyle intervention and provider feedback
- Keywords
- Pre-Diabetes, Metabolic Syndrome, Type 2 Diabetes, Diabetes Prevention, Lifestyle Modification, Diet Therapy, Provider Education
- Medical subject headings
- Glucose Intolerance, Metabolic Syndrome, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle intervention and provider feedbackBehavioural
Patients receive lifestyle education and counseling after each visit with their primary care provider. Lifestyle modification goals are set and progress monitored. Frequency is dependent on frequency of visits with primary care provider which can range from one month to nine months.
Primary care providers of the intervention patients receive one education session at the commencement of the study covering the diagnosis and treatment of metabolic syndrome and pre-diabetes. Feedback on provider performance as assessed by provider documentation of diagnosis and treatment recommendations compared to patient outcomes is given every six months.
| Study group | Role | What they receive |
|---|---|---|
| Provider/Patient Intervention Arm | Experimental | Lifestyle modification education and counseling for intervention patients. Diagnosis and treatment education and feedback on performance for providers of intervention patients. Receives: Behavioral: Lifestyle intervention and provider feedback |
| Provider/Patient Control Arm | No intervention | Pts will be informed that they have MetSyn and asked to speak with their PCP with any questions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients adopt healthy lifestyle behaviors leading to significant weight loss, thus reducing their risk of diabetes and heart disease
Weight loss from baseline
Measured: 1.5 years
Providers improve their ability to diagnose and treat metabolic syndrome/pre-diabetes.
Providers chart MetSyn in Problem List
Measured: 1.5 years
Secondary outcomes (6)
Improve patient understanding of the metabolic syndrome/pre-diabetes risk parameters and the impact of healthy lifestyle changes on reducing their risk of developing heart disease and diabetes.
Patient verbalizes values leading to MetSyn diagnosis
Measured: 1.5 years
Create a model multidisciplinary team (physician, nurse, dietitian, health educator) to conduct group visits, lifestyle intervention education and follow-up of patients with metabolic syndrome/pre-diabetes.
Multidisciplinary team created
Measured: 1.5 years
Develop a system-wide database of patients with metabolic syndrome/pre-diabetes to target for preventive care.
Database developed
Measured: 1.5 years
Establish physician discussions and documentations encouraging lifestyle changes such as weight loss, healthy dietary changes and exercise.
Documentation
Measured: 1.5 years
Involve nursing staff in waist circumference measurement along with vital signs.
Waist measurements documented
Measured: 1.5 years
Assess changes in insulin resistance using the HOMA-IR index and in vascular inflammation status using C-Reactive protein in the intervention and control groups.
HOMA-IR calculated
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2009 (estimated)
- Study startFeb 2006
- Primary completionNov 2007
- Study completionDec 2010
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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook County Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Leon Fogelfeld MD, Cook County Health
- Investigators
- Leon Fogelfeld, MD, Principal investigator, Cook County Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00853801
- Sponsor's protocol ID
- MetSyn-PDM
- Status last verified
- Jun 2023
- First submitted
- 27 Feb 2009
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting and Managing Metabolic Syndrome and Pre-Diabetes in General Medicine Clinic (Feasibility)
- ClinicalTrials.gov ID
- NCT00853801
- Acronym / sponsor ID
- MetSyn-PDM
- Conditions
- Pre-Diabetes, Metabolic Syndrome, Type 2 Diabetes
- Keywords
- Pre-Diabetes, Metabolic Syndrome, Type 2 Diabetes, Diabetes Prevention, Lifestyle Modification, Diet Therapy, Provider Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Cook County HealthOther government
- Study start
- Feb 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 2 Mar 2009 (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.
An educational intervention in the General Medicine Clinic aimed at both primary care providers (PCPs) and their patients with metabolic syndrome/pre-diabetes (MetSyn/PDM). Improving PCPs ability to detect and manage MetSyn/PDM, as measured by the increased incorporation of MetSyn/PDM into PCPs care plan, and increasing patients' awareness of healthy lifestyle behaviors results in positive patient health behaviors and outcomes.
Detailed description
The highest diabetes prevalence in the US is among African Americans (13.3%), American Indians (12.8%), and Mexican Americans (9.5%) with 8.7% of European Americans diagnosed with diabetes. In addition, certain minorities also have much higher rates of diabetes-related complications and death, in some instances by as much as 50% more than the general population, highlighting that the greatest need for preventive measures are amongst ethnic minorities.
The efficacy of lifestyle intervention in reducing the incidence of type 2 diabetes has been established by the Diabetes Prevention Program and other studies. The Cook County Bureau of Health Services, a publicly-funded healthcare system serving a primarily low-income, uninsured, ethnically diverse population in Chicago, IL, currently treats an estimated 40,000 patients annually for type 2 diabetes and estimates that another 85,000 to 100,000 patients are at risk for developing diabetes.
Our primary objective was to test the feasibility of integrating less intensive lifestyle intervention therapy into patient visits with their primary care provider to improve weight loss and decrease the intensity of metabolic syndrome and pre-diabetes risk factors. The site of the study is the General Medicine Clinic, a busy primary care outpatient site treating approximately 12,000 patients/year and 200 patients/day, staffed primarily by medical residents supervised by attending physicians.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Provider/Patient Intervention Arm | Experimental | Behavioral: Lifestyle intervention and provider feedbackLifestyle modification education and counseling for intervention patients. Diagnosis and treatment education and feedback on performance for providers of intervention patients. |
| Provider/Patient Control Arm | No intervention | –Pts will be informed that they have MetSyn and asked to speak with their PCP with any questions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has metabolic syndrome as defined by three or more of the five risk factors:
- Has a primary care provider in the General Medicine Clinic (GMC).
Key exclusion criteria (7 listed)
- Has been diagnosed with any of the following:
- Life expectancy less than 2 years
- Non-English speaking patient
- Patient whose physician is a PGY-3 resident, graduating before projected completion of 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 |
|---|---|---|
| Lifestyle intervention and provider feedbackPatients receive lifestyle education and counseling after each visit with their primary care provider. Lifestyle modification goals are set and progress monitored. Frequency is dependent on frequency of visits with primary care provider which can range from one month to nine months. Primary care providers of the intervention patients receive one education session at the commencement of the study covering the diagnosis and treatment of metabolic syndrome and pre-diabetes. Feedback on provider performance as assessed by provider documentation of diagnosis and treatment recommendations compared to patient outcomes is given every six months. | Behavioural | Provider/Patient Intervention Arm |
Primary outcome
Patients adopt healthy lifestyle behaviors leading to significant weight loss, thus reducing their risk of diabetes and heart disease
Time frame: 1.5 years
Weight loss from baseline
Providers improve their ability to diagnose and treat metabolic syndrome/pre-diabetes.
Time frame: 1.5 years
Providers chart MetSyn in Problem List
6 secondary outcomes
Improve patient understanding of the metabolic syndrome/pre-diabetes risk parameters and the impact of healthy lifestyle changes on reducing their risk of developing heart disease and diabetes.
Time frame: 1.5 years
Create a model multidisciplinary team (physician, nurse, dietitian, health educator) to conduct group visits, lifestyle intervention education and follow-up of patients with metabolic syndrome/pre-diabetes.
Time frame: 1.5 years
Develop a system-wide database of patients with metabolic syndrome/pre-diabetes to target for preventive care.
Time frame: 1.5 years
Establish physician discussions and documentations encouraging lifestyle changes such as weight loss, healthy dietary changes and exercise.
Time frame: 1.5 years
Involve nursing staff in waist circumference measurement along with vital signs.
Time frame: 1.5 years
Assess changes in insulin resistance using the HOMA-IR index and in vascular inflammation status using C-Reactive protein in the intervention and control groups.
Time frame: 1.5 years
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 26 Jun 2023.
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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.
Leon Fogelfeld, MD principal investigator
Cook County Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention and provider feedback in people with Pre-Diabetes and Metabolic Syndrome, run by Cook County Health at 1 site 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 7 inclusion and 7 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 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Patients adopt healthy lifestyle behaviors leading to significant weight loss, thus reducing their risk of diabetes and heart disease (time frame: 1.5 years). The study lists 2 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 26 Jun 2023.