Eating DisordersPhase 1NCT04636840
Leveraging Social Media to Identify and Connect Teens With Eating Disorders to a Mobile Guided Self-Help Mobile Intervention
A Phase 1 study testing Space From Body and Eating Concerns- Teen in people with Eating Disorders, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Space From Body and Eating Concerns- Teen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2020to 18 Dec 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- US Resident
- Owns or has daily access to an iOS or Android smartphone
- English-speaking
- Screen Positive for a DSM-5 subclinical/clinical eating disorder other than anorexia nervosa (AN) or at high risk for an eating disorder
Who cannot join
- Currently Engaged in eating disorder treatment
- Screen Positive for Anorexia Nervosa
- Wards of the State or Foster Children
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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.
- Conditions
- Eating Disorders
- Being tested
- Space From Body and Eating Concerns- Teen
- Keywords
- mHealth, eating disorders, bulimia nervosa, binge eating disorder, teens, adolescents, social media
- Medical subject headings
- Feeding and Eating Disorders, Bulimia Nervosa, Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Space From Body and Eating Concerns- TeenDevice
Mobile application with coaching component
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Access to a self-help version of Space From Body and Eating Concerns Program on SilverCloud Health App |
| Experimental Group A- Mobile App with Social Networking Feature | Experimental | Access to a coached Space From Body and Eating Concerns program on SilverCloud Health App with private social media group for social networking support. Receives: Device: Space From Body and Eating Concerns- Teen |
| Experimental Group B- Mobile App Only | Experimental | Access to a coached Space From Body and Eating Concerns program on SilverCloud Health App. Receives: Device: Space From Body and Eating Concerns- Teen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Disorder Psychopathology
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.
Measured: Baseline, 6 weeks, 3 months, 6 months
Secondary outcomes (2)
Quality of Life Scores
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).
Measured: Baseline, 6 weeks, 3 months, 6 months
Total Time Spent on the App
Among participants who logged in at least once, the total time spent on the app was collected and measured in seconds.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start18 Dec 2020
- Primary completion16 Dec 2022
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), SilverCloud Health, Palo Alto University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636840
- Sponsor's protocol ID
- 1R34MH119170-01
- Status last verified
- Feb 2026
- First submitted
- 13 Nov 2020
- Last updated
- 9 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All data will be deidentified and uploaded into data sharing structures on the NIMH Data Archive as compliant with funding source requirements.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Social Media to Identify and Connect Teens With Eating Disorders to a Mobile Guided Self-Help Mobile Intervention
- ClinicalTrials.gov ID
- NCT04636840
- Acronym / sponsor ID
- 1R34MH119170-01
- Conditions
- Eating Disorders
- Keywords
- mHealth, eating disorders, bulimia nervosa, binge eating disorder, teens, adolescents, social media
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), SilverCloud Health, Palo Alto University
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Posted 9 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Access to a self-help version of Space From Body and Eating Concerns Program on SilverCloud Health App |
| Experimental Group A- Mobile App with Social Networking Feature | Experimental | Device: Space From Body and Eating Concerns- TeenAccess to a coached Space From Body and Eating Concerns program on SilverCloud Health App with private social media group for social networking support. |
| Experimental Group B- Mobile App Only | Experimental | Device: Space From Body and Eating Concerns- TeenAccess to a coached Space From Body and Eating Concerns program on SilverCloud Health App. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- US Resident
- Owns or has daily access to an iOS or Android smartphone
- English-speaking
- Screen Positive for a DSM-5 subclinical/clinical eating disorder other than anorexia nervosa (AN) or at high risk for an eating disorder
Key exclusion criteria (3 listed)
- Currently Engaged in eating disorder treatment
- Screen Positive for Anorexia Nervosa
- Wards of the State or Foster Children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Space From Body and Eating Concerns- TeenMobile application with coaching component | Device | Experimental Group A- Mobile App with Social Networking Feature, Experimental Group B- Mobile App Only |
Primary outcome
Eating Disorder Psychopathology
Time frame: 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.
2 secondary outcomes
Quality of Life Scores
Time frame: Baseline, 6 weeks, 3 months, 6 months
Total Time Spent on the App
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All data will be deidentified and uploaded into data sharing structures on the NIMH Data Archive as compliant with funding source requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Space From Body and Eating Concerns- Teen in people with Eating Disorders, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Disorder Psychopathology (time frame: Baseline, 6 weeks, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.