Eating DisordersNCT05730348
Mealtime Anxiety in Eating Disorders
An observational study of Eating Disorders, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The goal of this observational study is to assess mealtime anxiety in patients with eating disorders receiving treatment at an in-patient unit. Anxiety wil be assessed using ecological momentary assessment (EMA). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Post mealtime activity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 33 participants
- Where
- 1 siteNorway
- Study dates
- 11 Sep 2023to 28 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will be patients suffering from eating disorders, treated at a specialized eating disorder unit, at tertiary level of health care. The population is expected to primarily consist of individuals suffering from anorexia nervosa, but all patients admitted to the ward will be invited to participate, independent of eating disorder diagnosis.
Who may be able to join
- All patients admitted to the Regional Department for Eating Disorders adult in-patient unit (>16 years old) will be invited to participate.
Who cannot join
- Patients who receive tube feeding for all meals during the study period will be excluded.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Oslo University Hospital, Regional Department for Eating Disorders
Oslo
About this study
Official title: Mealtime Anxiety in Eating Disorders: An Ecological Momentary Assessment (EMA) Project
The goal of this observational study is to assess mealtime anxiety in patients with eating disorders receiving treatment at an in-patient unit. Anxiety wil be assessed using ecological momentary assessment (EMA). The main research question is:
- Does post meal activity reduce anxiety in patients with eating disorders?
Study participation will last for two weeks. Participants will be reporting current levels of anxiety/distress on an EMA mobile app during treatment as usual. During one of the two study participation weeks, the participants will perform post mealtime activity.
- Conditions
- Eating Disorders
- Being tested
- Post mealtime activity
- 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.
Post mealtime activityBehavioural
Therapist lead movement post meals
| Study group | Role | What they receive |
|---|---|---|
| Patients with eating disorders | Not described Receives: Behavioral: Post mealtime activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self Reported Anxiety During Treatment as Usual vs Treatment as Usual plus Post-Mealtime Activity
Anxiety will be measured using the Subjective Units of Distress Scale (SUDS). Higher scores indicate higher levels of distress. The Affect Grid will also be used to assess current mood. Measures will be collected using Ecological Momentary Assessment (EMA).
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start11 Sep 2023
- Primary completion28 Apr 2025
- Study completion28 Apr 2025
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 Oslo University HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Dam Foundation
- Responsible party
- Principal investigator, Kristin Stedal, Oslo University Hospital
- Investigators
- Kristin Stedal, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730348
- Sponsor's protocol ID
- 541774
- Status last verified
- Oct 2026
- First submitted
- 7 Feb 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mealtime Anxiety in Eating Disorders: An Ecological Momentary Assessment (EMA) Project
- ClinicalTrials.gov ID
- NCT05730348
- Acronym / sponsor ID
- 541774
- Conditions
- Eating Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- The Dam Foundation
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 15 Feb 2023 (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 goal of this observational study is to assess mealtime anxiety in patients with eating disorders receiving treatment at an in-patient unit. Anxiety wil be assessed using ecological momentary assessment (EMA). The main research question is:
- Does post meal activity reduce anxiety in patients with eating disorders?
Study participation will last for two weeks. Participants will be reporting current levels of anxiety/distress on an EMA mobile app during treatment as usual. During one of the two study participation weeks, the participants will perform post mealtime activity.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with eating disorders | – | Behavioral: Post mealtime activity |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will be patients suffering from eating disorders, treated at a specialized eating disorder unit, at tertiary level of health care. The population is expected to primarily consist of individuals suffering from anorexia nervosa, but all patients admitted to the ward will be invited to participate, independent of eating disorder diagnosis.
Key inclusion criteria (1 listed)
- All patients admitted to the Regional Department for Eating Disorders adult in-patient unit (>16 years old) will be invited to participate.
Key exclusion criteria (1 listed)
- Patients who receive tube feeding for all meals during the study period will be excluded.
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 |
|---|---|---|
| Post mealtime activityTherapist lead movement post meals | Behavioural | Patients with eating disorders |
Primary outcome
Change in Self Reported Anxiety During Treatment as Usual vs Treatment as Usual plus Post-Mealtime Activity
Time frame: Two weeks
Anxiety will be measured using the Subjective Units of Distress Scale (SUDS). Higher scores indicate higher levels of distress. The Affect Grid will also be used to assess current mood. Measures will be collected using Ecological Momentary Assessment (EMA).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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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.
Kristin Stedal, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eating Disorders, run by Oslo University Hospital at 1 site in Norway.
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: finished, as of the sponsor's last update on 16 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Self Reported Anxiety During Treatment as Usual vs Treatment as Usual plus Post-Mealtime Activity (time frame: Two weeks). 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 16 Oct 2026; AzTrials last refreshed its copy on 1 Nov 2026.