Integrating Lifestyle Therapy for Diabetes Prevention Into Primary Care

NCT00853801 | Completed DMC

• 1 other identifier: MetSyn-PDM
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-Diabetes; Metabolic Syndrome; Type 2 Diabetes

Keywords

Pre-Diabetes; Metabolic Syndrome; Type 2 Diabetes; Diabetes Prevention; Lifestyle Modification; Diet Therapy; Provider Education

Outcome Measures

Primary Outcomes (2)

• Patients adopt healthy lifestyle behaviors leading to significant weight loss, thus reducing their risk of diabetes and heart disease

  Weight loss from baseline

  1.5 years

• Providers improve their ability to diagnose and treat metabolic syndrome/pre-diabetes.

  Providers chart MetSyn in Problem List

  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.

  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.

  1.5 years

• Develop a system-wide database of patients with metabolic syndrome/pre-diabetes to target for preventive care.

  1.5 years

• Establish physician discussions and documentations encouraging lifestyle changes such as weight loss, healthy dietary changes and exercise.

  1.5 years

• Involve nursing staff in waist circumference measurement along with vital signs.

  1.5 years

Study Arms (2)

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.

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.

Interventions

Lifestyle intervention and provider feedback 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 Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Cook County Health: lead

Study Sites (1)

John H Stroger Hospital

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Glucose Intolerance; Metabolic Syndrome; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Leon Fogelfeld, MD

  Cook County Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Division of Endocrinology

Study Record Dates

• First Submitted: February 27, 2009
• First Posted: March 2, 2009
• Study Start: February 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: December 1, 2010
• Last Updated: June 26, 2023

Record last verified: 2023-06

Locations

US (1)