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The purpose of this study is to conduct a randomized pilot trial of a mobile intervention that targets obesity and binge eating.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Condition 1 | Experimental | Behavioral weight loss intervention |
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| Condition 2 | Experimental | Behavioral weight loss intervention and decrease negative affect |
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| Condition 3 | Experimental | Behavioral weight loss intervention and decrease unhealthy weight control practices |
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| Condition 4 | Experimental | Behavioral weight loss intervention, decrease unhealthy weight control practices, and decrease negative affect |
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| Condition 5 | Experimental | Behavioral weight loss intervention and decrease overvaluation of weight and shape |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral weight loss | Behavioral | Participants will receive behavioral weight loss intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Weight | Changes in weight | Measured at baseline, post-intervention (16-weeks) |
| Binge Eating Episodes | Changes in episodes of binge eating (past 28 days) | Measured at baseline, post-intervention (16-weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Condition 1 | Behavioral weight loss intervention Behavioral weight loss: Participants will receive behavioral weight loss intervention |
| FG001 | Condition 2 | Behavioral weight loss intervention and decrease negative affect Behavioral weight loss: Participants will receive behavioral weight loss intervention Intervention component: Decrease negative affect: Participants will receive an intervention component to decrease negative affect |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 14, 2022 | Dec 20, 2023 |
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| Condition 6 | Experimental | Behavioral weight loss intervention, decrease overvaluation of weight and shape, and decrease negative affect |
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| Condition 7 | Experimental | Behavioral weight loss intervention, decrease overvaluation of weight and shape, and decrease unhealthy weight control practices |
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| Condition 8 | Experimental | Behavioral weight loss intervention, decrease overvaluation of weight and shape, decrease unhealthy weight control practices, and decrease negative affect |
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| Intervention component: Decrease overvaluation of weight and shape | Behavioral | Participants will receive an intervention component to decrease overvaluation of weight and shape |
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| Intervention component: Decrease unhealthy weight control practices | Behavioral | Participants will receive an intervention component to decrease unhealthy weight control practices |
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| Intervention component: Decrease negative affect | Behavioral | Participants will receive an intervention component to decrease negative affect |
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| FG002 | Condition 3 | Behavioral weight loss intervention and decrease unhealthy weight control practices Behavioral weight loss: Participants will receive behavioral weight loss intervention Intervention component: Decrease unhealthy weight control practices: Participants will receive an intervention component to decrease unhealthy weight control practices |
| FG003 | Condition 4 | Behavioral weight loss intervention, decrease unhealthy weight control practices, and decrease negative affect Behavioral weight loss: Participants will receive behavioral weight loss intervention Intervention component: Decrease unhealthy weight control practices: Participants will receive an intervention component to decrease unhealthy weight control practices Intervention component: Decrease negative affect: Participants will receive an intervention component to decrease negative affect |
| FG004 | Condition 5 | Behavioral weight loss intervention and decrease overvaluation of weight and shape Behavioral weight loss: Participants will receive behavioral weight loss intervention Intervention component: Decrease overvaluation of weight and shape: Participants will receive an intervention component to decrease overvaluation of weight and shape |
| FG005 | Condition 6 | Behavioral weight loss intervention, decrease overvaluation of weight and shape, and decrease negative affect Behavioral weight loss: Participants will receive behavioral weight loss intervention Intervention component: Decrease overvaluation of weight and shape: Participants will receive an intervention component to decrease overvaluation of weight and shape Intervention component: Decrease negative affect: Participants will receive an intervention component to decrease negative affect |
| FG006 | Condition 7 | Behavioral weight loss intervention, decrease overvaluation of weight and shape, and decrease unhealthy weight control practices Behavioral weight loss: Participants will receive behavioral weight loss intervention Intervention component: Decrease overvaluation of weight and shape: Participants will receive an intervention component to decrease overvaluation of weight and shape Intervention component: Decrease unhealthy weight control practices: Participants will receive an intervention component to decrease unhealthy weight control practices |
| FG007 | Condition 8 | Behavioral weight loss intervention, decrease overvaluation of weight and shape, decrease unhealthy weight control practices, and decrease negative affect Behavioral weight loss: Participants will receive behavioral weight loss intervention Intervention component: Decrease overvaluation of weight and shape: Participants will receive an intervention component to decrease overvaluation of weight and shape Intervention component: Decrease unhealthy weight control practices: Participants will receive an intervention component to decrease unhealthy weight control practices Intervention component: Decrease negative affect: Participants will receive an intervention component to decrease negative affect |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Condition 1 | Behavioral weight loss intervention Behavioral weight loss: Participants will receive behavioral weight loss intervention |
| BG001 | Condition 2 | Behavioral weight loss intervention and decrease negative affect Behavioral weight loss: Participants will receive behavioral weight loss intervention Intervention component: Decrease negative affect: Participants will receive an intervention component to decrease negative affect |
| BG002 | Condition 3 | Behavioral weight loss intervention and decrease unhealthy weight control practices Behavioral weight loss: Participants will receive behavioral weight loss intervention Intervention component: Decrease unhealthy weight control practices: Participants will receive an intervention component to decrease unhealthy weight control practices |
| BG003 | Condition 4 | Behavioral weight loss intervention, decrease unhealthy weight control practices, and decrease negative affect Behavioral weight loss: Participants will receive behavioral weight loss intervention Intervention component: Decrease unhealthy weight control practices: Participants will receive an intervention component to decrease unhealthy weight control practices Intervention component: Decrease negative affect: Participants will receive an intervention component to decrease negative affect |
| BG004 | Condition 5 | Behavioral weight loss intervention and decrease overvaluation of weight and shape Behavioral weight loss: Participants will receive behavioral weight loss intervention Intervention component: Decrease overvaluation of weight and shape: Participants will receive an intervention component to decrease overvaluation of weight and shape |
| BG005 | Condition 6 | Behavioral weight loss intervention, decrease overvaluation of weight and shape, and decrease negative affect Behavioral weight loss: Participants will receive behavioral weight loss intervention Intervention component: Decrease overvaluation of weight and shape: Participants will receive an intervention component to decrease overvaluation of weight and shape Intervention component: Decrease negative affect: Participants will receive an intervention component to decrease negative affect |
| BG006 | Condition 7 | Behavioral weight loss intervention, decrease overvaluation of weight and shape, and decrease unhealthy weight control practices Behavioral weight loss: Participants will receive behavioral weight loss intervention Intervention component: Decrease overvaluation of weight and shape: Participants will receive an intervention component to decrease overvaluation of weight and shape Intervention component: Decrease unhealthy weight control practices: Participants will receive an intervention component to decrease unhealthy weight control practices |
| BG007 | Condition 8 | Behavioral weight loss intervention, decrease overvaluation of weight and shape, decrease unhealthy weight control practices, and decrease negative affect Behavioral weight loss: Participants will receive behavioral weight loss intervention Intervention component: Decrease overvaluation of weight and shape: Participants will receive an intervention component to decrease overvaluation of weight and shape Intervention component: Decrease unhealthy weight control practices: Participants will receive an intervention component to decrease unhealthy weight control practices Intervention component: Decrease negative affect: Participants will receive an intervention component to decrease negative affect |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Changes in weight | Posted | Mean | Standard Deviation | pounds | Measured at baseline, post-intervention (16-weeks) |
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| Primary | Binge Eating Episodes | Changes in episodes of binge eating (past 28 days) | Posted | Mean | Standard Deviation | Change in number of episodes | Measured at baseline, post-intervention (16-weeks) |
|
7 months
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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 | Condition 1 | Behavioral weight loss intervention Behavioral weight loss: Participants will receive behavioral weight loss intervention | 0 | 10 | 0 | 10 | 0 | 10 |
| EG001 | Condition 2 | Behavioral weight loss intervention and decrease negative affect Behavioral weight loss: Participants will receive behavioral weight loss intervention Intervention component: Decrease negative affect: Participants will receive an intervention component to decrease negative affect | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Condition 3 | Behavioral weight loss intervention and decrease unhealthy weight control practices Behavioral weight loss: Participants will receive behavioral weight loss intervention Intervention component: Decrease unhealthy weight control practices: Participants will receive an intervention component to decrease unhealthy weight control practices | 0 | 10 | 0 | 10 | 0 | 10 |
| EG003 | Condition 4 | Behavioral weight loss intervention, decrease unhealthy weight control practices, and decrease negative affect Behavioral weight loss: Participants will receive behavioral weight loss intervention Intervention component: Decrease unhealthy weight control practices: Participants will receive an intervention component to decrease unhealthy weight control practices Intervention component: Decrease negative affect: Participants will receive an intervention component to decrease negative affect | 0 | 10 | 0 | 10 | 0 | 10 |
| EG004 | Condition 5 | Behavioral weight loss intervention and decrease overvaluation of weight and shape Behavioral weight loss: Participants will receive behavioral weight loss intervention Intervention component: Decrease overvaluation of weight and shape: Participants will receive an intervention component to decrease overvaluation of weight and shape | 0 | 11 | 0 | 11 | 0 | 11 |
| EG005 | Condition 6 | Behavioral weight loss intervention, decrease overvaluation of weight and shape, and decrease negative affect Behavioral weight loss: Participants will receive behavioral weight loss intervention Intervention component: Decrease overvaluation of weight and shape: Participants will receive an intervention component to decrease overvaluation of weight and shape Intervention component: Decrease negative affect: Participants will receive an intervention component to decrease negative affect | 0 | 10 | 0 | 10 | 0 | 10 |
| EG006 | Condition 7 | Behavioral weight loss intervention, decrease overvaluation of weight and shape, and decrease unhealthy weight control practices Behavioral weight loss: Participants will receive behavioral weight loss intervention Intervention component: Decrease overvaluation of weight and shape: Participants will receive an intervention component to decrease overvaluation of weight and shape Intervention component: Decrease unhealthy weight control practices: Participants will receive an intervention component to decrease unhealthy weight control practices | 0 | 10 | 0 | 10 | 0 | 10 |
| EG007 | Condition 8 | Behavioral weight loss intervention, decrease overvaluation of weight and shape, decrease unhealthy weight control practices, and decrease negative affect Behavioral weight loss: Participants will receive behavioral weight loss intervention Intervention component: Decrease overvaluation of weight and shape: Participants will receive an intervention component to decrease overvaluation of weight and shape Intervention component: Decrease unhealthy weight control practices: Participants will receive an intervention component to decrease unhealthy weight control practices Intervention component: Decrease negative affect: Participants will receive an intervention component to decrease negative affect | 0 | 10 | 0 | 10 | 0 | 10 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrea Graham | Northwestern University | 312-503-5266 | andrea.graham@northwestern.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 20, 2023 | Sep 16, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D002032 | Bulimia |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006963 | Hyperphagia |
| D012817 | Signs and Symptoms, Digestive |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG005 | Negative Affect (no) | Did not receive the negative affect intervention component |
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