Mealtime Anxiety in Eating Disorders

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.

Study Overview

• Status: Recruiting
• Conditions: Eating Disorders
• Intervention / Treatment: Behavioral: Post mealtime activity

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Kristin Stedal, PhD; Phone Number: +47 23027344; Email: krsted@ous-hf.no

Study Locations

• Norway
  • Oslo, Norway
    • Recruiting
    • Oslo University Hospital, Regional Department for Eating Disorders
    • Contact: Kristin Stedal, PhD; Phone Number: +4791321971; Email: krsted@ous-hf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with eating disorders	Behavioral: Post mealtime activity; Therapist lead movement post meals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: The Dam Foundation
• Investigators: Principal Investigator: Kristin Stedal, PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders
• Other Study ID Numbers: 541774

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No