Integrating Lifestyle Therapy for Diabetes Prevention Into Primary Care

NCT ID: NCT00853801

Last Updated: 2023-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2010-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Provider/Patient Intervention Arm

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

Group Type: EXPERIMENTAL

Lifestyle intervention and provider feedback

Intervention Type: BEHAVIORAL

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.

Provider/Patient Control Arm

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cook County Health

OTHER_GOV

Sponsor Role: lead

Responsible Party

Leon Fogelfeld MD

Chair, Division of Endocrinology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leon Fogelfeld, MD

Role: PRINCIPAL_INVESTIGATOR

Cook County Health

Locations

John H Stroger Hospital

Chicago, Illinois, United States

Countries

United States

Other Identifiers

MetSyn-PDM

Identifier Type: -

Identifier Source: org_study_id