Lifestyle Interventions for Long Term Diabetes Control

Not Applicable

• Conditions: Type 2 Diabetes

• Registration Number: NCT00364312
• Lead Sponsor: University of Virginia

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2004-05
• Status Verified: 2006-08
• Study First Submitted: 2006-08-11
• Study First Submitted QC: 2006-08-11
• Last Update Submitted: 2006-08-11
• Study First Posted: 2006-08-15
• Last Update Posted: 2006-08-15
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Quality of life
HbA1c
Body mass index
Waist circumference
Health care utilization
Lipids

Secondary Outcome Measures

Name	Time	Method
Diet
Physical activity
Self-efficacy
Diabetes knowledge
Social support

Trial Locations

Locations (1)

University of Virginia School of Medicine; 🇺🇸 Charlottesville, Virginia, United States