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Integrating Lifestyle Therapy for Diabetes Prevention Into Primary Care

Primary Purpose

Pre-Diabetes, Metabolic Syndrome, Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle intervention and provider feedback
Sponsored by
Cook County Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre-Diabetes focused on measuring Pre-Diabetes, Metabolic Syndrome, Type 2 Diabetes, Diabetes Prevention, Lifestyle Modification, Diet Therapy, Provider Education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • John H Stroger Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Provider/Patient Intervention Arm

Provider/Patient Control Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

Patients adopt healthy lifestyle behaviors leading to significant weight loss, thus reducing their risk of diabetes and heart disease
Weight loss from baseline
Providers improve their ability to diagnose and treat metabolic syndrome/pre-diabetes.
Providers chart MetSyn in Problem List

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.
Patient verbalizes values leading to MetSyn diagnosis
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.
Multidisciplinary team created
Develop a system-wide database of patients with metabolic syndrome/pre-diabetes to target for preventive care.
Database developed
Establish physician discussions and documentations encouraging lifestyle changes such as weight loss, healthy dietary changes and exercise.
Documentation
Involve nursing staff in waist circumference measurement along with vital signs.
Waist measurements documented
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.
HOMA-IR calculated

Full Information

First Posted
February 27, 2009
Last Updated
June 22, 2023
Sponsor
Cook County Health
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1. Study Identification

Unique Protocol Identification Number
NCT00853801
Brief Title
Integrating Lifestyle Therapy for Diabetes Prevention Into Primary Care
Official Title
Detecting and Managing Metabolic Syndrome and Pre-Diabetes in General Medicine Clinic (Feasibility)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cook County Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Diabetes, Metabolic Syndrome, Type 2 Diabetes
Keywords
Pre-Diabetes, Metabolic Syndrome, Type 2 Diabetes, Diabetes Prevention, Lifestyle Modification, Diet Therapy, Provider Education

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Provider/Patient Intervention Arm
Arm Type
Experimental
Arm Description
Lifestyle modification education and counseling for intervention patients. Diagnosis and treatment education and feedback on performance for providers of intervention patients.
Arm Title
Provider/Patient Control Arm
Arm Type
No Intervention
Arm Description
Pts will be informed that they have MetSyn and asked to speak with their PCP with any questions.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle intervention and provider feedback
Intervention Description
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 Measure Information:
Title
Patients adopt healthy lifestyle behaviors leading to significant weight loss, thus reducing their risk of diabetes and heart disease
Description
Weight loss from baseline
Time Frame
1.5 years
Title
Providers improve their ability to diagnose and treat metabolic syndrome/pre-diabetes.
Description
Providers chart MetSyn in Problem List
Time Frame
1.5 years
Secondary Outcome Measure Information:
Title
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.
Description
Patient verbalizes values leading to MetSyn diagnosis
Time Frame
1.5 years
Title
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.
Description
Multidisciplinary team created
Time Frame
1.5 years
Title
Develop a system-wide database of patients with metabolic syndrome/pre-diabetes to target for preventive care.
Description
Database developed
Time Frame
1.5 years
Title
Establish physician discussions and documentations encouraging lifestyle changes such as weight loss, healthy dietary changes and exercise.
Description
Documentation
Time Frame
1.5 years
Title
Involve nursing staff in waist circumference measurement along with vital signs.
Description
Waist measurements documented
Time Frame
1.5 years
Title
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.
Description
HOMA-IR calculated
Time Frame
1.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leon Fogelfeld, MD
Organizational Affiliation
Cook County Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
John H Stroger Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

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Integrating Lifestyle Therapy for Diabetes Prevention Into Primary Care

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