ClinicalTrials.gg
RecruitingNCT07807774Updated Oct 7, 2026

FlexED: National Substudy

An interventional study of FlexED in Eating Disorders and Body Image, sponsored by Duke University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Duke University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Updated Oct 7, 2026Primary outcomes revisedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 25 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 15 studies in Feeding and Eating Disorders by Duke University — 5 open to participants now, 5 under way, none of them phase 3. Feeding and Eating Disorders · Duke University.

Planned enrollment
7th of 12
100 · median 112
Started
2026
with 2 others
No phase
12 of 15
5 open now
Registered
15th of 15
by date

Among the 15 studies in Feeding and Eating Disorders by Duke University, this one is the 7th largest by planned enrollment of the 12 interventional ones that give a count, is one of 3 that started in 2026, is one of 12 with no phase, and was the 15th registered.

Feeding and Eating Disorders

645 studies on the registry are indexed under Feeding and Eating Disorders; 153 are open to participants now.

Browse Feeding and Eating Disorders studies →

Open to participants now

5 of the 15 studies in Feeding and Eating Disorders by Duke University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

Where they have run

Who these studies take

Of the 101 Feeding and Eating Disorders studies recruiting now, 31 (31%) set no upper age limit and 68 (67%) stop at 75 or younger; 46 take children under 18; 21 take healthy volunteers.

This study: 18 Years to 25 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 15 studies in Feeding and Eating Disorders by Duke University, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Eating Disorders
  • Body Image

Keywords

  • Body Image Flexibility
  • Eating Disorders
  • Acceptance and Commitment Therapy
  • Psychological Flexibility
  • Early Intervention
04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female between the age of 18-25 years old.

Exclusion criteria

Exclusion Criteria:

  • Non-English speaking
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    FlexED

    Seven 20-minute sessions of an online, multimedia application that teaches psychological flexibility with body-image related thoughts and feelings.

    Behavioral: FlexED

Interventions

  • BehavioralFlexED

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, Week 4, Week 8, Week 12

  2. 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.

    Time frame: Baseline, Week 4, Week 8, Week 12

  3. 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.

    Time frame: Baseline, Week 8, Week 12

  4. 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.

    Time frame: Baseline, Week 8, Week 12

  5. Acceptability of the Intervention

    Session completion rates

    Time frame: 8 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Data and data dictionaries will be made available at the time of publication.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Jul 2028, 22 months after the start.

Of 269 non-industry interventional studies with no phase under Feeding and Eating Disorders, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 49. This study's planned 22 months is below that.

Counting every sponsor, half of 274 studies reached it within 28 months; a quarter within 14 and three quarters within 49.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 2, 2026
First posted
Sep 8, 2026
StartActual
Aug 24, 2026
Primary completionEst.
Jul 15, 2028
CompletionEst.
Jul 31, 2028
Last update
Oct 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary outcomes
1 edited, 3 description edited
What changed in the outcomes
  • EditedChange from Baseline in the Eating Disorder Examination Questionnaire - Questionnaire Short Form (EDE-Q-SFQS)Time frame: Baseline, Week 8, Week 12
  • DescriptionChange from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ)-5: how it is measured was reworded
  • DescriptionChange from Baseline in the Comprehensive Assessment of Acceptance and Commitment Therapy Processes -10 (CompACT-10): how it is measured was reworded
  • DescriptionChange in Weight Concern Scale Score: how it is measured was reworded
Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    Primary outcomes 1 edited, 3 description edited
    What changed in the outcomes
    • EditedChange from Baseline in the Eating Disorder Examination Questionnaire - Questionnaire Short Form (EDE-Q-SFQS)Time frame: Baseline, Week 8, Week 12
    • DescriptionChange from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ)-5: how it is measured was reworded
    • DescriptionChange from Baseline in the Comprehensive Assessment of Acceptance and Commitment Therapy Processes -10 (CompACT-10): how it is measured was reworded
    • DescriptionChange in Weight Concern Scale Score: how it is measured was reworded

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07807774
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Sep 8, 2026
Start date
Aug 24, 2026
Primary completion
Jul 15, 2028 (estimated)
Completion
Jul 31, 2028 (estimated)
Last update
Oct 7, 2026

Study contacts

Dottie R Mayo
Contact
drm72@duke.edu
919-668-1935
Dottie R Mayo
principal investigator · Duke University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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