An interventional study of Feasibility/Efficacy Testing in Obesity, Binge-Eating Disorder and Binge Eating, sponsored by University of Pittsburgh. Active, not recruiting at 2 sites in United States. Open to participants aged 13 Years to 19 Years. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment
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:
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 50 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All participants will all be assigned to the experimental group in this single-arm open trial.
Behavioral: Feasibility/Efficacy Testing
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.
Usability of intervention
Perceptions that the intervention is or would be useful, useable, and satisfactory will be measured by the System Usability Scale.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Through study completion (up to 9 months)
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.
Time frame: Pre-intervention assessment
Intervention targets (activity patterns)
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).
Time frame: 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)
Time frame: 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).
Time frame: Through study completion (up to 9 months)
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Pittsburgh