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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK066759 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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After a three month weight loss phase involving the use of meal replacements, participants are randomized into different weight loss maintenance conditions. Aim 1: To test the hypothesis that the meal replacement (MR) and reduced energy density eating (REDE) interventions, when added separately to the LEARN program, will produce superior weight loss maintenance compared to a LEARN-only intervention. Aim 2: To test the hypothesis that the weight loss maintenance condition that combines MRs and REDE will produce better maintenance of weight losses than either individual component and than the LEARN-only condition. Aim 3: To test the hypothesis that the two conditions receiving the REDE intervention will experience longer-lasting improvements in the energy density and nutritional composition of the diet compared to the two non-REDE conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MR-/REDE- | Experimental | Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy for weight loss maintenance. |
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| MR+/REDE- | Experimental | Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy and use of meal replacements for weight loss maintenance. |
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| MR-/REDE+ | Experimental | Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy as well as Reduced Energy Density Education for weight loss maintenance. |
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| MR+/REDE+ | Experimental | Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy, as well as Reduced Energy Density Education and continued meal replacement use, for weight loss maintenance. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight Loss Phase | Behavioral | Weight loss using CBT and meal replacements |
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| Measure | Description | Time Frame |
|---|---|---|
| Weight | baseline, 3 months, 12 months, 24 months, 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition | baseline, 3 months, 12 months, 24 months, 36 months | |
| Blood work results | baseline, 3 months, 12 months, 24 months | |
| Scores on questionnaire-based measures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael R Lowe, PhD | Drexel University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Drexel University | Philadelphia | Pennsylvania | 19102 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Continued CBT | Behavioral | Using CBT during weight loss maintenance |
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| reduced energy density education | Behavioral | Additional nutritional learning |
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| continued use of meal replacements | Behavioral | continued use of meal replacements during weight loss maintenance |
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| baseline, 3 months, 12 months, 24 months, 36 months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |