Integrating Lifestyle Therapy for Diabetes Prevention Into Primary Care
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00853801|
Recruitment Status : Completed
First Posted : March 2, 2009
Last Update Posted : October 2, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pre-Diabetes Metabolic Syndrome Type 2 Diabetes||Behavioral: Lifestyle intervention and provider feedback||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||112 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||Detecting and Managing Metabolic Syndrome and Pre-Diabetes in General Medicine Clinic (Feasibility)|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||December 2010|
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.
- Patients adopt healthy lifestyle behaviors leading to significant weight loss, thus reducing their risk of diabetes and heart disease [ Time Frame: 1.5 years ]
- Providers improve their ability to diagnose and treat metabolic syndrome/pre-diabetes. [ Time Frame: 1.5 years ]
- 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 ]
- 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 ]
- Develop a system-wide database of patients with metabolic syndrome/pre-diabetes to target for preventive care. [ Time Frame: 1.5 years ]
- Establish physician discussions and documentations encouraging lifestyle changes such as weight loss, healthy dietary changes and exercise. [ Time Frame: 1.5 years ]
- Involve nursing staff in waist circumference measurement along with vital signs. [ Time Frame: 1.5 years ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00853801
|United States, Illinois|
|John H Stroger Hospital|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Leon Fogelfeld, MD||John H. Stroger Hospital|