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| Name | Class |
|---|---|
| The Beverage Institute. | UNKNOWN |
| Temple University | OTHER |
| MRC Human Nutrition Research | OTHER_GOV |
| National Development and Research Institutes, Inc. |
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This study was designed to test the impact of a 12-week online behavioral modification program for weight loss, with or without a fortified beverage. Subjects are randomized to four conditions: 1) Online Basic Lifestyle Counseling (OBLI); 2) Online Lifestyle Counseling (OLC); 3) OBLI plus a beverage (BEV); 4) OLC + BEV. The three hypotheses were: 1)after 12 weeks, individuals in the OLC condition would lose more weight than those in OBLI; 2) after 12 weeks, the OLC + BEV condition would lose more weight than the OLC condition; and 3) after 12 weeks, the OBLI + BEV condition would lose more weight than the OBLI condition.
This study tests the impact of an innovative combination of a fortified beverage (a diet cola containing green tea extract, soluble dextrin fiber, and caffeine) and an online support weight loss program in a multi-center randomized clinical trial. The study compares the impact of all combinations of the beverage and the online behavioral modification treatment program over 12 weeks at three treatment center in the US and EU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Online basic lifestyle counseling (OBLI) | Experimental | Subjects receive one online informational class. |
|
| Online lifestyle counseling (OLC) | Experimental | Subjects receive 12 weekly online classes with a focus on behavior modification for weight loss. |
|
| OBLI intervention plus a fortified diet beverage (BEV) | Experimental | Subjects receive online basic lifestyle information (OBLI) plus a fortified diet beverage. |
|
| OLC plus fortified diet beverage (BEV) | Experimental | Subjects receive OLC plus diet beverage (BEV). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| online lifestyle counseling and a fortified diet beverage | Behavioral | The fortified diet beverage contains green tea extract (total catechin 167 mg), soluble dextrin fiber (10 g), and caffeine (100 mg). |
| Measure | Description | Time Frame |
|---|---|---|
| body weight | Body weight is assessed at baseline, 6 and 12 weeks. Body weight is determined using a calibrated scale. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| DEXA-determined fat mass | Body fat percent is determined by DEXA using a whole body scanner. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John P Foreyt, Ph.D. | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Temple University | Philadelphia | Pennsylvania | United States | |||
| Behavioral Medicine Research Center |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| OTHER |
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| Houston |
| Texas |
| 77030 |
| United States |
| MRC Human Nutrition Research | Cambridge | United Kingdom |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |