Integrating Lifestyle Therapy for Diabetes Prevention Into Primary Care

Cook County Health

Status: Completed

Conditions: Type 2 Diabetes; Pre-Diabetes; Metabolic Syndrome

Treatments: Behavioral: Lifestyle intervention and provider feedback

Study type: Interventional

Funder types: Other

Identifiers

NCT00853801

MetSyn-PDM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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114 participants in 2 patient groups

Provider/Patient Intervention Arm

Experimental group

Description:

Lifestyle modification education and counseling for intervention patients. Diagnosis and treatment education and feedback on performance for providers of intervention patients.

Treatment:

Behavioral: Lifestyle intervention and provider feedback

Provider/Patient Control Arm

No Intervention group

Description:

Pts will be informed that they have MetSyn and asked to speak with their PCP with any questions.