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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diet and physical activity | Behavioral |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | ||
| Waist circumference | ||
| Body mass index | ||
| Lipids | ||
| Health care utilization | ||
| Quality of life |
| Measure | Description | Time Frame |
|---|---|---|
| Diet | ||
| Physical activity | ||
| Diabetes knowledge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Viktor E Bovbjerg, PhD MPH | University of Virginia | Principal Investigator |
| Jayne Q Crowther, RN MSN | University of Virginia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia School of Medicine | Charlottesville | Virginia | 22908 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009043 | Motor Activity |
| D003920 | Diabetes Mellitus |
| D015438 | Health Behavior |
| D010342 | Patient Acceptance of Health Care |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D009043 | Motor Activity |
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| Social support |
| Self-efficacy |
| D001519 | Behavior |
| D000074822 | Treatment Adherence and Compliance |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |