Lifestyle Interventions for Long Term Diabetes Control

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2006 by University of Virginia.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00364312
First received: August 11, 2006
Last updated: NA
Last verified: August 2006
History: No changes posted
  Purpose

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 Intervention
Type 2 Diabetes
Behavioral: diet and physical activity

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Control With Activity and Nutrition

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • HbA1c
  • Waist circumference
  • Body mass index
  • Lipids
  • Health care utilization
  • Quality of life

Secondary Outcome Measures:
  • Diet
  • Physical activity
  • Diabetes knowledge
  • Social support
  • Self-efficacy

Estimated Enrollment: 390
Study Start Date: May 2004
Estimated Study Completion Date: December 2009
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00364312

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

No publications provided

ClinicalTrials.gov Identifier: NCT00364312     History of Changes
Other Study ID Numbers: R18 DK062942
Study First Received: August 11, 2006
Last Updated: August 11, 2006
Health Authority: United States: Federal Government

Keywords provided by University of Virginia:
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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 30, 2014