Mealtime Anxiety in Eating Disorders

Sponsor
Oslo University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05730348
Collaborator
The Dam Foundation (Other)
40
15

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Post mealtime activity

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Mealtime Anxiety in Eating Disorders: An Ecological Momentary Assessment (EMA) Project
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Patients with eating disorders

Behavioral: Post mealtime activity
Therapist lead movement post meals

Outcome Measures

Primary Outcome Measures

  1. Change in Self Reported Anxiety During Treatment as Usual vs Treatment as Usual plus Post-Mealtime Activity [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Oslo University Hospital
  • The Dam Foundation

Investigators

  • Principal Investigator: Kristin Stedal, PhD, Oslo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kristin Stedal, Researcher, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT05730348
Other Study ID Numbers:
  • 541774
First Posted:
Feb 15, 2023
Last Update Posted:
Feb 15, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 15, 2023