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| ID | Type | Description | Link |
|---|---|---|---|
| 1R56HL116517-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of this study is to learn the impact stress may have on weight management and emotional eating.
The investigator's long-term goal is to contribute to the development of empirically-based, clinically-useful weight loss and weight maintenance interventions. The objective in this application is to obtain proof of feasibility for a weight loss and maintenance intervention that addresses the underlying issue of stress, as an effective approach to long-term weight loss and maintenance. The central hypothesis for this application is that the weight management intervention utilizing stress management skills will produce weight loss and significant improvements in stress and metabolic syndrome biomarkers at 10 and 20 weeks follow-up. This hypothesis was formulated based upon data showing that stress is associated with increased risk of obesity and a few small studies that have shown this method of stress management can produce long-term weight loss and maintenance and decreased depression and stress. The rationale for the proposed studies is that proof of feasibility for such an intervention will enable subsequent definitive studies at the R01 level. If, however, the investigators were to unexpectedly disprove the concept, such a result would also be valuable because it would lead the investigators to shift focus and redistribute resources accordingly. To test the central hypothesis, and thereby accomplish the objective for this application, the following specific aims will be pursued:
At the completion of this study, the investigators expect to determine the type of intervention that produces the greatest weight loss in a community sample at 10 and 20 weeks follow-up. The investigators will also have determined what impact the two interventions have on secondary outcomes, including stress as measured by salivary cortisol and telomere length; depression, disordered eating patterns, dietary intake, and physical activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stress Management | Experimental | Approximately half of the participants will be randomized to a stress management arm. Participants will undergo Emotional Brain Training during a 90 minute session once per week for ten weeks in order to rewire the brain and improve stress management techniques. |
|
| standard behavioral weight loss | Active Comparator | Half of participants will receive a standard behavioral weight loss program in 90 minute sessions once per week for 10 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emotional brain training | Behavioral | Stress management based program |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Loss | Weight change from baseline to 20 weeks | Weight change from baseline to 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in Stress | Stress was measured by the Perceived Stress Scale (PSS). This scale measures stress on a scale of 0 to 40 points. The results are reported as a total score on the scale. Higher numbers indicate more stress than lower numbers. | PSS change from baseline to 20 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelly H Webber, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40506 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stress Management | Approximately half of the participants will be randomized to a stress management arm. Participants will undergo Emotional Brain Training during a 90 minute session once per week for ten weeks in order to rewire the brain and improve stress management techniques. Emotional brain training: Stress management based program |
| FG001 | Standard Behavioral Weight Loss | Half of participants will receive a standard behavioral weight loss program in 90 minute sessions once per week for 10 weeks Behavioral weight loss: Standard behavioral weight loss |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stress Management | Approximately half of the participants will be randomized to a stress management arm. Participants will undergo Emotional Brain Training during a 90 minute session once per week for ten weeks in order to rewire the brain and improve stress management techniques. Emotional brain training: Stress management based program |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight Loss | Weight change from baseline to 20 weeks | Posted | Mean | Standard Deviation | kg | Weight change from baseline to 20 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stress Management | Approximately half of the participants will be randomized to a stress management arm. Participants will undergo Emotional Brain Training during a 90 minute session once per week for ten weeks in order to rewire the brain and improve stress management techniques. Emotional brain training: Stress management based program |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly Webber, PhD, RD, LD | UKentucky | 859-257-4351 | 859 | kelly.webber@uky.edu |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D015431 | Weight Loss |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Behavioral weight loss |
| Behavioral |
Standard behavioral weight loss |
|
| BG001 |
| Standard Behavioral Weight Loss |
Half of participants will receive a standard behavioral weight loss program in 90 minute sessions once per week for 10 weeks Behavioral weight loss: Standard behavioral weight loss |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
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| Secondary | Decrease in Stress | Stress was measured by the Perceived Stress Scale (PSS). This scale measures stress on a scale of 0 to 40 points. The results are reported as a total score on the scale. Higher numbers indicate more stress than lower numbers. | Posted | Mean | 90% Confidence Interval | units on a scale | PSS change from baseline to 20 weeks |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Standard Behavioral Weight Loss | Half of participants will receive a standard behavioral weight loss program in 90 minute sessions once per week for 10 weeks Behavioral weight loss: Standard behavioral weight loss | 0 | 25 | 0 | 25 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |