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| Name | Class |
|---|---|
| Palo Alto Medical Foundation | OTHER |
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The trial will test whether the Alive multi-channel delivery health behavior program can positively affect weight and glucose level in pre-diabetics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| participation in Alive-PD | Experimental | Alive-PD lifestyle intervention with multi-channel delivery |
|
| Control | Placebo Comparator | Usual care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alive-PD | Behavioral | Weekly email/web goal-setting intervention to improve physical activity, diet and weight loss for pre-diabetics, with additional phone support |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in body weight | Mean weight loss and the proportion of subjects who achieve a 5% body weight loss at 3 and 6 months and maintain at 12 months | at 3 months, 6 months and one year |
| Change from baseline in diabetes risk markers | Change in blood glucose level and hemoglobin A1c (HbA1c) as measured in clinic at 3 and 6 months and maintain at 12 months | at 3 months, 6 months and one year |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in physical activity and dietary factors | Extent of change in physical activity and dietary factors as reported in questionnaires | 3 months and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gladys Block, PhD | Berkeley Analytics, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palo Alto Medical Foundation Research Institute | Palo Alto | California | 94301 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25608692 | Background | Block G, Azar KM, Block TJ, Romanelli RJ, Carpenter H, Hopkins D, Palaniappan L, Block CH. A Fully Automated Diabetes Prevention Program, Alive-PD: Program Design and Randomized Controlled Trial Protocol. JMIR Res Protoc. 2015 Jan 21;4(1):e3. doi: 10.2196/resprot.4046. | |
| 26499966 | Result | Block G, Azar KM, Romanelli RJ, Block TJ, Hopkins D, Carpenter HA, Dolginsky MS, Hudes ML, Palaniappan LP, Block CH. Diabetes Prevention and Weight Loss with a Fully Automated Behavioral Intervention by Email, Web, and Mobile Phone: A Randomized Controlled Trial Among Persons with Prediabetes. J Med Internet Res. 2015 Oct 23;17(10):e240. doi: 10.2196/jmir.4897. |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D003920 | Diabetes Mellitus |
| D009765 | Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Usual Care | Behavioral | Placebo Control |
|
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |