Lifestyle Interventions for Long Term Diabetes Control

August 11, 2006 updated by: University of Virginia

Improving Control With Activity and Nutrition

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment

390

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University Of Virginia School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Quality of life
HbA1c
Waist circumference
Health care utilization
Body mass index
Lipids

Secondary Outcome Measures

Outcome Measure
Self-efficacy
Social support
Diet
Physical activity
Diabetes knowledge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Viktor E Bovbjerg, PhD MPH, University of Virginia
  • Study Director: Jayne Q Crowther, RN MSN, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Completion

December 1, 2009

Study Registration Dates

First Submitted

August 11, 2006

First Submitted That Met QC Criteria

August 11, 2006

First Posted (Estimate)

August 15, 2006

Study Record Updates

Last Update Posted (Estimate)

August 15, 2006

Last Update Submitted That Met QC Criteria

August 11, 2006

Last Verified

August 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R18DK062942 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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