Lifestyle Interventions for Long Term Diabetes Control

Type 2 Diabetes Clinical Trial

Official title:

Improving Control With Activity and Nutrition

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00364312
• Other study ID #: R18DK062942
• Status: Active, not recruiting
• Phase: N/A
• First received: August 11, 2006
• Last updated: August 11, 2006
• Start date: May 2004
• Est. completion date: December 2009

Study information

• Verified date: August 2006
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 390
• Est. completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Intervention

Behavioral:
• diet and physical activity

Locations

Country	Name	City	State
United States	University of Virginia School of Medicine	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c
Primary	Waist circumference
Primary	Body mass index
Primary	Lipids
Primary	Health care utilization
Primary	Quality of life
Secondary	Diet
Secondary	Physical activity
Secondary	Diabetes knowledge
Secondary	Social support
Secondary	Self-efficacy