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Lifestyle Interventions for Long Term Diabetes Control

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ClinicalTrials.gov Identifier: NCT00364312
Recruitment Status : Unknown
Verified August 2006 by University of Virginia.
Recruitment status was:  Active, not recruiting
First Posted : August 15, 2006
Last Update Posted : August 15, 2006
Information provided by:
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.

Condition or disease Intervention/treatment
Type 2 Diabetes Behavioral: diet and physical activity

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Control With Activity and Nutrition
Study Start Date : May 2004
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. HbA1c
  2. Waist circumference
  3. Body mass index
  4. Lipids
  5. Health care utilization
  6. Quality of life

Secondary Outcome Measures :
  1. Diet
  2. Physical activity
  3. Diabetes knowledge
  4. Social support
  5. Self-efficacy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00364312

United States, Virginia
University of Virginia School of Medicine
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Principal Investigator: Viktor E Bovbjerg, PhD MPH University of Virginia
Study Director: Jayne Q Crowther, RN MSN University of Virginia

ClinicalTrials.gov Identifier: NCT00364312     History of Changes
Other Study ID Numbers: R18DK062942 ( U.S. NIH Grant/Contract )
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: August 15, 2006
Last Verified: August 2006

Keywords provided by University of Virginia:
behavior therapy
dietary control
diabetes mellitus
behavior modification
blood glucose
clinical trial
diabetes education
health behavior
health care service utilization
quality of life

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases