NCT05539807

Brief Summary

This prospective one-arm study aims to examine short and long-term changes in dysfunctional eating among individuals who signed up for an 8-week, group based, low threshold, mindfulness-based intervention. The study is an extension of a quality assurance project which was provided by a nation-wide self-help organization for people with self-identified eating problems. Eating disorder symptoms and the proposed predictors (self-kindness, self-judgment and mindfulness) were registered online at 12 measurement time points. In the current study we will invite the same participants to complete the same measures four years after the intervention.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
197

participants targeted

Target at P75+ for not_applicable

Timeline
51mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Progress46%
Oct 2022Aug 2030

First Submitted

Initial submission to the registry

August 24, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2030

Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

3.8 years

First QC Date

August 24, 2022

Last Update Submit

July 24, 2025

Conditions

Keywords

Eating DisorderMindfulnessSelf-compassionLongitudinalWithin-personLong-term

Outcome Measures

Primary Outcomes (2)

  • Change in eating disorder symptoms measured by Eating Disorder Examination Questionnaire (EDE-Q)

    A self-report questionnaire measuring eating disorder symptoms by Fairburn and colleagues

    Pre, weekly during treatment - 8 weeks, post, 6 months follow-up, four years follow-up

  • Change in self-kindness, self-judgement and mindfulness from the Self-compassion scale

    Subscales from the self-compassion scale of Kristin Neff and colleagues. Self-kindness indicates the tendency to respond with kindness to own feelings of distress and failure (e.g. I try to be understanding and patient towards those aspects of my personality I don't like). Self-judgment indicates the tendency to respond with self-judgment to own feelings of distress and failure (self-judgment, e.g. I'm disapproving and judgmental about my own flaws and inadequacies). Mindfulness indicates the tendency to respond with balanced awareness to own feelings of distress and failure. E.g.: "When something painful happens I try to take a balanced view of the situation".

    Pre, weekly during treatment - 8 weeks, post, 6 months follow-up, four years follow-up

Secondary Outcomes (2)

  • Change in mindful eating as measured by the Mindful Eating Questionnaire

    Pre, post, 6 months follow up, four-years follow-up

  • Change in relationship and life Satisfaction

    Pre, post, 6 months follow up, four-years follow-up

Study Arms (1)

Intervention

EXPERIMENTAL

All participants receive the intervention

Behavioral: Mindful Eating Conscious Living

Interventions

MECL is a 8 week mindfulness-based group intervention. Each session is of 2.5-3 hours duration. During the sessions, theories about eating-related difficulties in general are presented, participants are guided in mindfulness practices and participants who want to share their experiences in the group can do so. Topics include: (1) What is mindfulness, why and how can we use mindfulness in relation to eating (2) slowing down, taking breaks and noticing different types of "hunger" (e.g. physical hunger and the "hunger" for comfort - "heart hunger) (3) working with satiety and satisfaction (4) becoming aware of patterns associated with one's eating behaviors, (5) awareness of feelings and bodily sensations (6) Food and mood (7) craving, and finally (8) working with "heart hunger" and emotional eating. Six to 10 participants participated in each group.

Intervention

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Self-identifying as having a binge-eating related problem and being 16 years or older.

You may not qualify if:

  • High suicidal risk, serious self-harm, active psychosis, active major depressive episode, anorexia nervosa, BMI \< 18, or debilitating social anxiety.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bergen

Bergen, Bergen, 5009, Norway

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ingrid Dundas, PhD

    University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 24, 2022

First Posted

September 14, 2022

Study Start

October 1, 2022

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2030

Last Updated

July 29, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Deidentified quantitative data will be shared.

Time Frame
After completion of the study and for five years.
Access Criteria
Data will be deposited in relevant data depositories and shared with researchers with legitimate interest who's research seems ethically sound.

Locations