Eating DisordersNCT07807774
FlexED: National Substudy
A study testing FlexED in people with Eating Disorders and Body Image, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to test the feasibility of disseminating an intervention broadly. "FlexED" is a digital gamified intervention targeting eating disorder symptoms in young women and girls at risk by changing how they experience thoughts and feelings about their body. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Eating Disorders, Body Image
- What is being tested?
- FlexED
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Female between the age of 18-25 years old.
Who cannot join
- Non-English speaking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27705
Dottie R Mayo, 919-668-1935, drm72@duke.edu
Rhonda M Merwin, PhD
About this study
Official title: FlexED: A Digital Gamified Early Intervention for Eating Disorders
The purpose of this study is to test the feasibility of disseminating an intervention broadly. "FlexED" is a digital gamified intervention targeting eating disorder symptoms in young women and girls at risk by changing how they experience thoughts and feelings about their body. The digital intervention is based on Acceptance and Commitment Therapy (ACT).
Participants complete seven 20-minute sessions of the intervention using their smartphone over about 8 weeks. Participants also complete questionnaires bi-weekly as they go through the intervention. A final measurement is taken one month after the last digital intervention session. These surveys are all conducted online. Participants are in the study for up to 12 weeks.
- Conditions
- Eating Disorders, Body Image
- Being tested
- FlexED
- Keywords
- Body Image Flexibility, Eating Disorders, Acceptance and Commitment Therapy, Psychological Flexibility, Early Intervention
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlexEDBehavioural
Intervention consists of seven 20-minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn psychological flexibility skills for body-image distress by completing interactive exercises and games with a relatable character and story line and receive rewards that reinforce learning.
| Study group | Role | What they receive |
|---|---|---|
| FlexED | Experimental | Seven 20-minute sessions of an online, multimedia application that teaches psychological flexibility with body-image related thoughts and feelings. Receives: Behavioral: FlexED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ)-5
Self-report measure of body-image psychological flexibility. The measure consists of 5 items that ask about the degree to which thoughts and feelings about the body interfere with living. Scores range from 5-35, with higher scores indicating greater flexibility/adaptability.
Measured: Baseline, Week 4, Week 8, Week 12
Change from Baseline in the Comprehensive Assessment of Acceptance and Commitment Therapy Processes -10 (CompACT-10)
A 10-item measure of psychological flexibility as a multidimensional construct with subscales of Openness, Awareness and Engagement. Openness scores range from 0-18, Awareness 0-18, and Engagement 0-24. Higher scores indicate greater flexibility/adaptability.
Measured: Baseline, Week 4, Week 8, Week 12
Change in Weight Concern Scale Score
5-item measure of weight concerns (worry about weight, fear of weight gain, dieting history, importance of weight, fear of fatness). Scores range from 0-100, with elevated scores (scores >= 47) having been associated with an increased risk of developing an eating disorder.
Measured: Baseline, Week 8, Week 12
Change from Baseline in the Eating Disorder Examination Questionnaire - Short (EDE-QS)
Short questionnaire format (12 items) of the clinician-administered interview assessing eating disorder symptom severity. Scores range from 0-36, with higher scores indicating greater symptomatology.
Measured: Baseline, Week 8, Week 12
Acceptability of the Intervention
Session completion rates
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start24 Aug 2026
- Primary completion15 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Dottie R Mayo, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807774
- Sponsor's protocol ID
- Pro00111571_2
- Other IDs
- 4R33MH127137-03
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data and data dictionaries will be made available at the time of publication.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FlexED: A Digital Gamified Early Intervention for Eating Disorders
- ClinicalTrials.gov ID
- NCT07807774
- Acronym / sponsor ID
- Pro00111571_2
- Conditions
- Eating Disorders, Body Image
- Keywords
- Body Image Flexibility, Eating Disorders, Acceptance and Commitment Therapy, Psychological Flexibility, Early Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 24 Aug 2026 (actual)
- Primary completion
- 15 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the feasibility of disseminating an intervention broadly. "FlexED" is a digital gamified intervention targeting eating disorder symptoms in young women and girls at risk by changing how they experience thoughts and feelings about their body. The digital intervention is based on Acceptance and Commitment Therapy (ACT).
Participants complete seven 20-minute sessions of the intervention using their smartphone over about 8 weeks. Participants also complete questionnaires bi-weekly as they go through the intervention. A final measurement is taken one month after the last digital intervention session. These surveys are all conducted online. Participants are in the study for up to 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FlexED | Experimental | Behavioral: FlexEDSeven 20-minute sessions of an online, multimedia application that teaches psychological flexibility with body-image related thoughts and feelings. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female between the age of 18-25 years old.
Key exclusion criteria (1 listed)
- Non-English speaking
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 |
|---|---|---|
| FlexEDIntervention consists of seven 20-minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn psychological flexibility skills for body-image distress by completing interactive exercises and games with a relatable character and story line and receive rewards that reinforce learning. | Behavioural | FlexED |
Primary outcome
Change from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ)-5
Time frame: Baseline, Week 4, Week 8, Week 12
Self-report measure of body-image psychological flexibility. The measure consists of 5 items that ask about the degree to which thoughts and feelings about the body interfere with living. Scores range from 5-35, with higher scores indicating greater flexibility/adaptability.
Change from Baseline in the Comprehensive Assessment of Acceptance and Commitment Therapy Processes -10 (CompACT-10)
Time frame: Baseline, Week 4, Week 8, Week 12
A 10-item measure of psychological flexibility as a multidimensional construct with subscales of Openness, Awareness and Engagement. Openness scores range from 0-18, Awareness 0-18, and Engagement 0-24. Higher scores indicate greater flexibility/adaptability.
Change in Weight Concern Scale Score
Time frame: Baseline, Week 8, Week 12
5-item measure of weight concerns (worry about weight, fear of weight gain, dieting history, importance of weight, fear of fatness). Scores range from 0-100, with elevated scores (scores >= 47) having been associated with an increased risk of developing an eating disorder.
Change from Baseline in the Eating Disorder Examination Questionnaire - Short (EDE-QS)
Time frame: Baseline, Week 8, Week 12
Short questionnaire format (12 items) of the clinician-administered interview assessing eating disorder symptom severity. Scores range from 0-36, with higher scores indicating greater symptomatology.
Acceptability of the Intervention
Time frame: 8 weeks
Session completion rates
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Yes. Data and data dictionaries will be made available at the time of publication.
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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.
Dottie R Mayo principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FlexED in people with Eating Disorders and Body Image, run by Duke University 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 7 Oct 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dottie R Mayo (919-668-1935, drm72@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ)-5 (time frame: Baseline, Week 4, Week 8, Week 12). The study lists 5 primary outcomes in all. 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 7 Oct 2026.