Integrating Lifestyle Therapy for Diabetes Prevention Into Primary Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00853801
Recruitment Status : Completed
First Posted : March 2, 2009
Last Update Posted : October 2, 2014
Information provided by (Responsible Party):
Leon Fogelfeld, John H. Stroger Hospital

Brief 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 increasing patients' awareness of healthy lifestyle behaviors results in positive patient health behaviors and outcomes.

Condition or disease Intervention/treatment Phase
Pre-Diabetes Metabolic Syndrome Type 2 Diabetes Behavioral: Lifestyle intervention and provider feedback Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Official Title: Detecting and Managing Metabolic Syndrome and Pre-Diabetes in General Medicine Clinic (Feasibility)
Study Start Date : February 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : December 2010

Arm Intervention/treatment
Experimental: 1
Lifestyle modification education and counseling for intervention patients. Diagnosis and treatment education and feedback on performance for providers of intervention patients.
Behavioral: Lifestyle intervention and provider feedback

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.

Primary Outcome Measures :
  1. Patients adopt healthy lifestyle behaviors leading to significant weight loss, thus reducing their risk of diabetes and heart disease [ Time Frame: 1.5 years ]
  2. Providers improve their ability to diagnose and treat metabolic syndrome/pre-diabetes. [ Time Frame: 1.5 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Develop a system-wide database of patients with metabolic syndrome/pre-diabetes to target for preventive care. [ Time Frame: 1.5 years ]
  4. Establish physician discussions and documentations encouraging lifestyle changes such as weight loss, healthy dietary changes and exercise. [ Time Frame: 1.5 years ]
  5. Involve nursing staff in waist circumference measurement along with vital signs. [ Time Frame: 1.5 years ]
  6. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00853801

United States, Illinois
John H Stroger Hospital
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
John H. Stroger Hospital
Principal Investigator: Leon Fogelfeld, MD John H. Stroger Hospital

Responsible Party: Leon Fogelfeld, Chair, Division of Endocrinology, John H. Stroger Hospital Identifier: NCT00853801     History of Changes
Other Study ID Numbers: MetSyn-PDM
First Posted: March 2, 2009    Key Record Dates
Last Update Posted: October 2, 2014
Last Verified: September 2014

Keywords provided by Leon Fogelfeld, John H. Stroger Hospital:
Metabolic Syndrome
Type 2 Diabetes
Diabetes Prevention
Lifestyle Modification
Diet Therapy
Provider Education

Additional relevant MeSH terms:
Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Diabetes Mellitus, Type 2
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Insulin Resistance