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NCT04636840

Leveraging Social Media to Identify and Connect Teens With Eating Disorders to a Mobile Guided Self-Help Mobile Intervention

Completed Phase 1 Results posted Last updated 9 March 2026
What this trial tests

Phase 1 trial testing Space From Body and Eating Concerns- Teen in Eating Disorders in 161 participants. Completed in 18 December 2023.

Timeline
18 December 2020
Primary endpoint
16 December 2022
18 December 2023

Quick facts

Lead sponsorWashington University School of Medicine
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment161
Start date18 December 2020
Primary completion16 December 2022
Estimated completion18 December 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Washington University School of Medicine

Who can join

Adults 14 to 17, any sex, with Eating Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Eating Disorder Psychopathology Primary · Baseline, 6 weeks, 3 months, 6 months

Eating disorder psychopathology was assessed using the self-report Eating Disorder Examination Questionnaire (EDE-Q). The EDE-Q Global score was calculated as the mean of the Restraint, Eating Concern, Shape Concern, and Weight Concern subscales (items scored 0-6), with higher scores indicating greater severity of eating disorder symptoms.

Baseline
GroupValue95% CI
Experimental Group A- Mobile App With Social Networking Feature3.75± 1.11
Experimental Group B- Mobile App Only3.93± 1.07
Control Group3.71± 1.17
6-Week follow-up
GroupValue95% CI
Experimental Group A- Mobile App With Social Networking Feature3.50± 1.23
Experimental Group B- Mobile App Only3.30± 1.36
Control Group2.91± 1.19
3-Month follow-up (end of intervention)
GroupValue95% CI
Experimental Group A- Mobile App With Social Networking Feature2.92± 1.46
Experimental Group B- Mobile App Only2.89± 1.50
Control Group3.01± 1.31
6-Month follow-up (3-Month post intervention)
GroupValue95% CI
Experimental Group A- Mobile App With Social Networking Feature2.54± 1.61
Experimental Group B- Mobile App Only2.57± 1.50
Control Group2.78± 1.22
Quality of Life Scores Secondary · Baseline, 6 weeks, 3 months, 6 months

Health-related quality of life was assessed using the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales. The total score ranges from 0 to 100 and is calculated as the mean of all answered items (i.e., sum of transformed item scores divided by the number of items answered), with higher scores indicating better quality of life (fewer problems).

Baseline
GroupValue95% CI
Experimental Group A- Mobile App With Social Networking Feature50.63± 16.37
Experimental Group B- Mobile App Only54.37± 15.37
Control Group52.65± 19.01
6-week
GroupValue95% CI
Experimental Group A- Mobile App With Social Networking Feature55.97± 15.53
Experimental Group B- Mobile App Only53.29± 20.61
Control Group49.96± 14.95
3-month
GroupValue95% CI
Experimental Group A- Mobile App With Social Networking Feature58.32± 14.68
Experimental Group B- Mobile App Only56.30± 18.88
Control Group53.51± 16.73
6-month
GroupValue95% CI
Experimental Group A- Mobile App With Social Networking Feature65.36± 20.08
Experimental Group B- Mobile App Only61.47± 17.34
Control Group56.39± 16.81
Total Time Spent on the App Secondary · 3 months

Among participants who logged in at least once, the total time spent on the app was collected and measured in seconds.

GroupValue95% CI
Experimental Group A- Mobile App With Social Networking Feature30031175 – 7971
Experimental Group B- Mobile App Only2520.5358.00 – 8591
Control Group1490368 – 4186
Depression Symptoms Secondary · Baseline, 6 weeks, 3 months, 6 months

Participants' depression symptoms were assessed using the Patient Health Questionnaire (PHQ-8). This questionnaire includes eight items with scores ranging from 0 to 24 (the ninth item assessing suicidal ideation was removed, consistent with other remote and digital health studies among teens). The total score ranges from 0 to 24, with a higher score indicating more severe depressive symptoms.

Baseline
GroupValue95% CI
Experimental Group A- Mobile App With Social Networking Feature14.98± 5.43
Experimental Group B- Mobile App Only14.98± 5.44
Control Group14.86± 6.19
6-week
GroupValue95% CI
Experimental Group A- Mobile App With Social Networking Feature13.08± 5.54
Experimental Group B- Mobile App Only14.51± 6.50
Control Group13.21± 5.78
3-month
GroupValue95% CI
Experimental Group A- Mobile App With Social Networking Feature11.06± 6.12
Experimental Group B- Mobile App Only11.85± 7.42
Control Group12.19± 6.06
6-month
GroupValue95% CI
Experimental Group A- Mobile App With Social Networking Feature9.65± 6.71
Experimental Group B- Mobile App Only10.32± 6.12
Control Group10.68± 6.01
Anxiety Symptoms Secondary · Baseline, 6 weeks, 3 months, 6 months

Anxiety symptoms were assessed using the Screen for Child Anxiety Related Emotional Disorders (SCARED; 41 items). Participants rated each item based on how true it was for the last 3 months (0 = not true/hardly ever true, 1 = somewhat true/sometimes true, 2 = very true/often true). The total score is the sum of all items (range 0-82). Higher scores indicate more severe anxiety symptoms.

Baseline
GroupValue95% CI
Experimental Group A- Mobile App With Social Networking Feature47.60± 16.12
Experimental Group B- Mobile App Only42.27± 12.00
Control Group45.33± 19.07
6-week
GroupValue95% CI
Experimental Group A- Mobile App With Social Networking Feature39.29± 11.73
Experimental Group B- Mobile App Only45.21± 19.85
Control Group46.95± 17.55
3-month
GroupValue95% CI
Experimental Group A- Mobile App With Social Networking Feature36.86± 12.41
Experimental Group B- Mobile App Only43.56± 18.18
Control Group43.92± 17.30
6-month
GroupValue95% CI
Experimental Group A- Mobile App With Social Networking Feature34.30± 14.58
Experimental Group B- Mobile App Only36.89± 19.35
Control Group42.97± 17.68

Sponsor's own description

Clinical or subclinical eating disorders (EDs) impact 10% of individuals in their lifetime and are marked by significant functional impairment, early mortality, chronicity, and emotional distress. ED symptoms often emerge in adolescence, with peak onset age in the teenage years. Early recognition and treatment of these devastating illnesses are needed to prevent long-term consequences and a chronic course. Most (80%) individuals with EDs, including teens with EDs (TwEDs), do not receive treatment. Due to major barriers to access and to the delivery of treatment for TwEDs, there is a need for a new model of service delivery that can identify and help TwEDs. We demonstrated our ability to harness social media to identify and efficiently recruit large numbers of TwEDs. Our team has successfully developed a guided self-help cognitive behavioral therapy (CBT)-based mobile app for previous studies and have adapted this app to address the specific needs of TwEDs. In proposed study, we will test this updated mHealth intervention, which includes simplified language and tailored content relevant to adolescent issues and a social networking feature designed to facilitate group exchanges. This mHealth intervention will be investigated among 161 TwEDs recruited from Instagram/Facebook to test preliminary efficacy and feasibility of this mHealth intervention to improved eating disorder symptoms among TwEDs not currently engaged in treatment. We will also garnering feedback via a mixed methods approach on the efficiency, technical effectiveness, and satisfaction with mHealth intervention content and features. Participants will be randomized to one of 3 study arms, including a control group (self-help version of the app), a group with access to the coached mobile app only, and a group with access to the coached mobile app plus social networking feature. We hypothesized that those with access to the coached mobile app intervention will have improved ED outcomes in comparison to the control group, and that those with access to the additional social networking feature will have the most improvement in ED symptoms out of all three groups.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Eating disorder symptoms and comorbid mental health risk among teens recruited to a digital intervention research study via two online approaches.
    Kasson E, Szlyk HS, Li X, Constantino-Pettit A, et al · · 2024 · cited 3× · PMID 38445416 · DOI 10.1002/eat.24186

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04636840.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing