Lifestyle Interventions for Long Term Diabetes Control

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Control With Activity and Nutrition

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: diet and physical activity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: diet and physical activity|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  |  | 
| Waist circumference |  |  | 
| Body mass index |  |  | 
| Lipids |  |  | 
| Health care utilization |  |  | 
| Quality of life |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diet |  |  | 
| Physical activity |  |  | 
| Diabetes knowledge |  |  | 
| Social support |  |  | 
| Self-efficacy |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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