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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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The purpose of the study is to investigate the effectiveness of three lifestyle treatment programs varying in level of intensiveness on prevention of pioglitazone-induced weight gain and to measure the composition of the change in body weight.
The three lifestyle interventions were usual care (1 visit), standard care (4 total visits) and intensive care (10 total visits)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | No Intervention | usual care. Subjects had one 90 minute visit with registered dietitian | |
| 2. | Active Comparator | Standard care. Subjects had 4 sessions with registered dietitian |
|
| 3 | Active Comparator | Intensive care. subjects had 10 visits with registered dietitian |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle modification | Behavioral | lifestyle intervention includes meal planning, food preparation, food label reading, dining out, and physical activity counseling |
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| Measure | Description | Time Frame |
|---|---|---|
| change in body weight | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change in body composition | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert F Kushner, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital Wellness Institute | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D015430 | Weight Gain |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |