Clinical trial NCT00364312: Lifestyle Interventions for Long Term Diabetes Control
Official title: Improving Control With Activity and Nutrition
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: behavior therapy
dietary control
exercise
diabetes mellitus
behavior modification
blood glucose
clinical trial
diabetes education
health behavior
health care service utilization
obesity
quality of life
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2006-08-15
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: HbA1c
measure: Waist circumference
measure: Body mass index
measure: Lipids
measure: Health care utilization
measure: Quality of life
Secondary outcomes:
measure: Diet
measure: Physical activity
measure: Diabetes knowledge
measure: Social support
measure: Self-efficacy
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia School of Medicine
state: Virginia
Study officials:
affiliation: University of Virginia
name: Viktor E Bovbjerg, PhD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia
name: Jayne Q Crowther, RN MSN
role: STUDY_DIRECTOR
References: