Mealtime Anxiety in Eating Disorders

Eating Disorders Clinical Trial

Official title:

Mealtime Anxiety in Eating Disorders: An Ecological Momentary Assessment (EMA) Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05730348
• Other study ID #: 541774
• Status: Recruiting
• Start date: September 11, 2023
• Est. completion date: June 2025

Study information

• Verified date: November 2023
• Source: Oslo University Hospital
• Contact: Kristin Stedal, PhD
• Phone: 23027344
• Email: krsted[@]ous-hf.no
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Eating Disorders
• Feeding and Eating Disorders

Intervention

Behavioral:
• Post mealtime activity
Therapist lead movement post meals

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Regional Department for Eating Disorders	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	The Dam Foundation

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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