NCT05730348

Brief 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). 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

September 11, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 27, 2025

Status Verified

March 1, 2025

Enrollment Period

1.8 years

First QC Date

February 7, 2023

Last Update Submit

June 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    Two weeks

Study Arms (1)

Patients with eating disorders

Behavioral: Post mealtime activity

Interventions

Therapist lead movement post meals

Patients with eating disorders

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • All patients admitted to the Regional Department for Eating Disorders adult in-patient unit (\>16 years old) will be invited to participate.

You may not qualify if:

  • Patients who receive tube feeding for all meals during the study period will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital, Regional Department for Eating Disorders

Oslo, Norway

RECRUITING

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Kristin Stedal, PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin Stedal, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

February 7, 2023

First Posted

February 15, 2023

Study Start

September 11, 2023

Primary Completion

July 1, 2025

Study Completion

December 1, 2025

Last Updated

June 27, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations