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The purpose of this study is to conduct a pilot trial of a mobile intervention that targets binge eating and weight-related behaviors, to determine the feasibility, acceptability, and preliminary efficacy of the intervention among adults with recurrent binge eating, diabetes, and food insecurity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral intervention | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FoodSteps | Behavioral | Participants will get access to the FoodSteps digital intervention with coaching for 16 weeks and receive a weekly stipend benefit to aid with implementing health behavior changes |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | Feasibility assessed by study recruitment and retention rates | 16 weeks |
| Study Retention Rate | Feasibility assessed by study recruitment and retention rates | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | FoodSteps | Digital intervention with coaching for 16 weeks and a weekly stipend benefit |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FoodSteps | Digital intervention with coaching for 16 weeks and a weekly stipend benefit |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Race (NIH/OMB) | 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 | Recruitment Rate | Feasibility assessed by study recruitment and retention rates | Posted | Count of Participants | Participants | 16 weeks |
|
|
16 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 | FoodSteps | Digital intervention with coaching for 16 weeks and a weekly stipend benefit |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea Graham | Northwestern University Feinberg School of Medicine | 312-503-5266 | andrea.graham@northwestern.edu |
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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 | Jun 14, 2024 | Dec 11, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 15, 2025 | Jan 27, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002032 | Bulimia |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D006963 | Hyperphagia |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
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| Primary | Study Retention Rate | Feasibility assessed by study recruitment and retention rates | Posted | Count of Participants | Participants | 16 weeks |
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| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
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| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |