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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DK080909 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
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The purpose of this study is to compare standard Behavior Therapy (BT), BT plus Meal Replacements (MR) and a condition focusing on the nutritional changes to the home food environment (HFE) on weight loss, weight loss maintenance, nutritional composition of the diet and psychosocial outcomes. A second aim is to determine the degree to which the specific targets of the experimental interventions do in fact change in the anticipated direction during the intervention and to evaluate whether such changes might account for improvements in weight loss maintenance. This study is important because it could provide the first evidence that the current standard of care for obesity lifestyle treatment could be improved by the addition of MRs or a program of comprehensive nutritional change.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavior Therapy | Active Comparator | Behavioral treatment strategies will be utilized to facilitate adherence to the treatment goals in all three treatments. Participants in the BT condition will receive only the BT intervention. Strategies that will be emphasized are listed below:
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| Behavior Therapy + Meal Replacements | Experimental | The BT +MR condition will implement behavioral treatment strategies in a way that is nearly identical to that of the BT condition. However, participants in this condition also will use MRs during weight loss and weight loss maintenance. |
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| Nutritrol | Experimental | Participants in this condition will be informed about the evidence indicating that the availability, structure and composition of foods they encounter or seek out in their daily lives will play a major role in determining their ability to maintain the weight they lose. We will present the treatment as an opportunity to make numerous changes to their "personal food environment" involving the variety, energy density, nutritional composition, and portion size of the foods they encounter in every day life. The Nutritrol condition is comprised of several components:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavior Therapy | Behavioral | Weight loss using CBT and continued CBT during weight loss maintenance. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Body weight over time. | Change in body weight measured on electronic scale. | Baseline, 6 months, 12 months, 18 months, 24 months, 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael R Lowe, Ph.D. | Drexel University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Drexel University | Philadelphia | Pennsylvania | 19102 | United States | ||
| University of Pennsylvania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29381791 | Derived | Lowe MR, Butryn ML, Zhang F. Evaluation of meal replacements and a home food environment intervention for long-term weight loss: a randomized controlled trial. Am J Clin Nutr. 2018 Jan 1;107(1):12-19. doi: 10.1093/ajcn/nqx005. | |
| 28845608 | Derived | Feig EH, Lowe MR. Variability in Weight Change Early in Behavioral Weight Loss Treatment: Theoretical and Clinical Implications. Obesity (Silver Spring). 2017 Sep;25(9):1509-1515. doi: 10.1002/oby.21925. |
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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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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Meal Replacements | Dietary Supplement | Weight loss using CBT and meal replacements. |
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| Nutritrol | Behavioral | To make widespread nutritional changes to participants personal food environments. |
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| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |