Lifestyle Interventions for Long Term Diabetes Control

Phase

N/A

Condition

Diabetes Prevention

Diabetes Mellitus Types I And Ii

Diabetes And Hypertension

Treatment

N/A

Clinical Study ID

NCT00364312

R18DK062942

Ages > 18
All Genders
Accepts Healthy Volunteers

Study Summary

Lifestyle interventions have been shown to reduce heart disease risk and improve blood sugar control in clinical trials. This project will investigate whether those lifestyle interventions can be implemented long-term, in usual practice settings, by using dietitian case managers to coordinate lifestyle change in cooperation with fitness instructors and primary care clinicians.

Eligibility Criteria

Inclusion

Inclusion Criteria:

treated for type 2 diabetes within one year prior to their entry into the trial, havea BMI at or above 30, and are 18 years of age or older

Exclusion

Exclusion Criteria:

1. end-stage renal disease (defined as being on dialysis), 2) active foot ulcers orinfections (defined as an open wound or requiring drug therapy), 3) pulmonary,cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic and malignantdisease (other than non-melanoma skin cancer) that precludes diet and physicalactivity changes

Study Design

May 01, 2004

December 31, 2009

Study Description

The proposed randomized trial investigates the effectiveness of lifestyle case management to encourage long-term lifestyle modifications in diet and physical activity, improve control of type 2 diabetes, reduce risk factors for progression of type 2 diabetes and cardiovascular disease, and improve quality of life, among health plan enrollees with type 2 diabetes and obesity. Patients agreeing to participate are randomly assigned to one of two conditions: 1) lifestyle case management, in which initial 12 month intensive diet and physical activity intervention is followed by 30 months of active maintenance directed by dietitians and physical trainers (the “lifestyle case management” group); 2) lifestyle intervention, in which there is no formal maintenance following the intensive lifestyle intervention (the “lifestyle intervention” group). Because the lifestyle case management intervention incorporates the content of the lifestyle intervention, we will be able to assess the incremental effectiveness of providing post-intervention lifestyle case management on glycemic control, cardiovascular risk, body composition, diet and physical activity habits, and health care utilization.

Connect with a study center

University of Virginia School of Medicine
Charlottesville, Virginia 22908
United States
Site Not Available

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