Integrating Lifestyle Therapy for Diabetes Prevention Into Primary Care

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by John H. Stroger Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
John H. Stroger Hospital
ClinicalTrials.gov Identifier:
NCT00853801
First received: February 27, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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 Intervention
Pre-Diabetes
Metabolic Syndrome
Type 2 Diabetes
Behavioral: Lifestyle intervention and provider feedback

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Prevention
Official Title: Detecting and Managing Metabolic Syndrome and Pre-Diabetes in General Medicine Clinic (Feasibility)

Resource links provided by NLM:


Further study details as provided by John H. Stroger Hospital:

Primary Outcome Measures:
  • Patients adopt healthy lifestyle behaviors leading to significant weight loss, thus reducing their risk of diabetes and heart disease [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Providers improve their ability to diagnose and treat metabolic syndrome/pre-diabetes. [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Develop a system-wide database of patients with metabolic syndrome/pre-diabetes to target for preventive care. [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Establish physician discussions and documentations encouraging lifestyle changes such as weight loss, healthy dietary changes and exercise. [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Involve nursing staff in waist circumference measurement along with vital signs. [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 112
Study Start Date: February 2006
Estimated Study Completion Date: December 2010
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00853801

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

No publications provided

Responsible Party: Leon Fogelfeld, MD, Chief, Division of Endocrinology, John H Stroger Hospital/Cook County Bureau of Health Services
ClinicalTrials.gov Identifier: NCT00853801     History of Changes
Other Study ID Numbers: MetSyn-PDM
Study First Received: February 27, 2009
Last Updated: February 27, 2009
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 26, 2014