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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK136540-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Northwestern University | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The aim of this project is to pilot test a novel mobile app intervention for adolescents with dysregulated eating behaviors and elevated weight status. This intervention will incorporate evidence-informed strategies targeting self-regulation into cognitive-behavioral treatment for maladaptive eating. Adolescents will use the app for 16 weeks and provide feedback on its usability and effectiveness in managing dysregulated eating.
This trial is part of a multi-phase project to create and test a mobile app intervention aimed at helping teenagers regulate their eating behaviors. Participation in this trial involves the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feasibility/Efficacy Testing Participants | Experimental | All participants will all be assigned to the experimental group in this single-arm open trial. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feasibility/Efficacy Testing | Behavioral | This digital intervention will include elements of adapted cognitive-behavioral treatment for adolescent binge eating and weight control, with a focus on self-regulation and skills use. |
| Measure | Description | Time Frame |
|---|---|---|
| Usability of intervention | Perceptions that the intervention is or would be useful, useable, and satisfactory will be measured by the System Usability Scale. | Week 16 |
| Acceptability of intervention | Perceptions that the intervention is or would be useful, useable, and satisfactory will be measured by the Usefulness, Satisfaction, and Ease of use questionnaire (USE). | Week 16 |
| Body mass index percentile | Adolescents will have their height and weight measured to calculate body mass index percentile using nationally representative growth charts and accompanying procedures. These data will be collected at each of the 4 major time points (pre-intervention assessment, mid-intervention assessment, post-intervention assessment, and 4-month follow up assessment). | Through study completion (up to 9 months) |
| Dysregulated eating | Dysregulated eating (overeating and loss of control eating episodes) will be measured using the Eating Disorder Examination (EDE; interview and questionnaire). The EDE features 4 subscales that are rated on a 7-point forced-choice format (0-6), with higher scores reflecting greater severity or frequency. These measures will be completed at each of the 4 major time points (pre-intervention assessment, mid-intervention assessment, post-intervention assessment, and 4-month follow up assessment). | Through study completion (up to 9 months) |
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| Measure | Description | Time Frame |
|---|---|---|
| Comorbid diagnoses | Comorbid psychiatric diagnoses will be reported by the adolescent's caregiver using the Child and Adolescent Symptom Inventory (CASI). Medical comorbid diagnoses will be reported by both the adolescent and their caregiver. | Pre-intervention assessment |
| Intervention targets (activity patterns) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea B Goldschmidt, Ph.D. | University of Pittsburgh | Principal Investigator |
| Andrea K Graham, Ph.D. | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60208 | United States | ||
| University of Pittsburgh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41421758 | Derived | Goldschmidt AB, Ortega A, Rooper IR, Obleada KT, Chapa DAN, Silverberg B, Stalvey E, Camino MK, Levine MD, Yu L, Eichen DM, Graham AK. Virtual Intervention for Binge Eating (VIBE): Study protocol for a user-informed mobile intervention for dysregulated eating and weight gain prevention in adolescents. Contemp Clin Trials. 2026 Feb;161:108192. doi: 10.1016/j.cct.2025.108192. Epub 2025 Dec 18. |
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Research data from participants may be shared with the broader scientific community after publication. We will make data and documentation available only under a data-sharing agreement that provides for a commitment to: (1) use the data for research purposes only; (2) secure the data using appropriate computer technology; (3) destroy or return the data after analyses are completed; and (4) not attempt to identify participants individually. Information shared with outside collaborators will link personal health information to a unique study ID in order to maintain participant anonymity.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 15, 2026 | Jul 6, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D056912 | Binge-Eating Disorder |
| D002032 | Bulimia |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Open trial
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Activity patterns (intervention target) will be measured using FitBit data during the intervention. Adolescents will track their activity using the FitBit over a 1-week period at each of the 4 major time points (pre-intervention assessment, mid-intervention assessment, post-intervention assessment, and 4-month follow up assessment). |
| Through study completion (up to 9 months) |
| Intervention targets (dietary patterns) | Dietary patterns (intervention target) will be measured using phone-based 24-hour dietary recalls. Adolescents will complete 3 food recalls over a 1-week period at each of the 4 major time points (pre-intervention assessment, mid-intervention assessment, post-intervention assessment, and 4-month follow up assessment) | Through study completion (up to 9 months) |
| Putative treatment mechanisms (general) | General self-regulation (putative mechanism) will be measured using the Self-Regulation Questionnaire. Items on the Self-Regulation Questionnaire are scored from 1 (strongly disagree) to 5 (strongly agree), with higher scores indicated higher self-regulation abilities. The questionnaire will be completed at each of the 4 major time points (pre-intervention assessment, mid-intervention assessment, post-intervention assessment, and 4-month follow up assessment). | Through study completion (up to 9 months) |
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
| D006963 | Hyperphagia |
| D012817 | Signs and Symptoms, Digestive |