Lifestyle Interventions for Long Term Diabetes Control

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Type 2 Diabetes

Clinical Trial Details

NCT number	NCT00364312
Study type	Interventional
Source	University of Virginia
Contact
Status	Active, not recruiting
Phase	N/A
Start date	May 2004
Completion date	December 2009

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05219994` - Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum	N/A
Completed	`NCT04056208` - Pistachios Blood Sugar Control, Heart and Gut Health	Phase 2
Completed	`NCT02284893` - Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone	Phase 3
Completed	`NCT04274660` - Evaluation of Diabetes and WELLbeing Programme	N/A
Active, not recruiting	`NCT05887817` - Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR)	Phase 4
Active, not recruiting	`NCT05566847` - Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes	N/A
Recruiting	`NCT06007404` - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Completed	`NCT04965506` - A Study of IBI362 in Chinese Patients With Type 2 Diabetes	Phase 2
Recruiting	`NCT06115265` - Ketogenic Diet and Diabetes Demonstration Project	N/A
Active, not recruiting	`NCT03982381` - SGLT2 Inhibitor or Metformin as Standard Treatment of Early Stage Type 2 Diabetes	Phase 4
Completed	`NCT04971317` - The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages	N/A
Completed	`NCT04496154` - Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood	N/A
Completed	`NCT04023539` - Effect of Cinnamomum Zeylanicum on Glycemic Levels of Adult Patients With Type 2 Diabetes	N/A
Recruiting	`NCT05572814` - Transform: Teaching, Technology, and Teams	N/A
Enrolling by invitation	`NCT05530356` - Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
Completed	`NCT03960424` - Diabetes Management Program for Hispanic/Latino	N/A
Completed	`NCT04097600` - A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets	Phase 1
Completed	`NCT05378282` - Identification of Diabetic Nephropathy Biomarkers Through Transcriptomics
Active, not recruiting	`NCT06010004` - A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes	Phase 3
Completed	`NCT03653091` - Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes	N/A