Eating DisordersNCT05539807
Mindfulness and Eating Disorder Symptoms
A study testing Mindful Eating Conscious Living in people with Eating Disorders, run by University of Bergen at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Mindful Eating Conscious Living
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteNorway
- Study dates
- 1 Oct 2022to Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Self-identifying as having a binge-eating related problem and being 16 years or older.
Who cannot join
- High suicidal risk, serious self-harm, active psychosis, active major depressive episode, anorexia nervosa, BMI < 18, or debilitating social anxiety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Short and Long-term Changes in Eating Disorder Symptoms During and After a Low-threshold Mindfulness-based Intervention Administered by a Self-help Organization in Norway
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.
Read the detailed description
Recent literature-reviews suggest that mindfulness-based interventions may be effective in treating problems related to dysfunctional eating such as binge eating and emotional eating. Less is known about the processes through which change happens. Moreover, long-term follow-up is scarce. The main aim of the current project is to examine the role of self-kindness and self-judgement in predicting changes in eating disorder symptoms four years after, and to analyze longitudinal data for the entire project. Measures were administrated before the intervention, each week during the intervention, after the intervention, at follow-up 6 months after the intervention and at a second follow up four years after the intervention.
The intervention is an 8-week mindfulness-based eating program (Mindful Eating Conscious Living). This intervention was administered by a nation-wide Norwegian self-help eating disorder organization. Participants who enrolled in the program (N=197) were asked to complete standardized self-report instruments at recruitment (T1), digitally during each of the 8-week sessions (T2-T9), after the intervention was completed (T10) and six months after the intervention was completed (T11).
The current study - a PhD project - will invite the same participants to complete the same measures four years after completing the program. This will provide a rich data set, collected over four years.
The main hypotheses are:
Self-kindness and self-judgment as predictors of ED symptoms
- During the intervention, self-kindness and self-judgment at a given week will predict eating disorder (ED) symptoms the following week (within-person).
- Level of self-kindness and self-judgement will predict the level of ED symptoms during the whole course (pre, each week during the intervention, post and four-year follow-up) (between-person).
- Pre-post changes in self-kindness and self-judgment will predict level of ED symptoms at six-month and four-year follow up (between-person changes)
Secondary hypotheses are:
- During the intervention, mindfulness (from the self-compassion scale) at a given week will predict ED symptoms the following week (within-person change) 5) Level of mindfulness will predict the level of ED symptoms during the whole course (pre, each week during the intervention, post and four-year follow-up) (between-person).
- Pre-post changes in mindfulness and mindful eating will predict changes in ED symptoms, and relationship and life-satisfaction, at six month and four-year follow-up (between-person changes).
- Pre-post changes in shame will predict changes in ED symptoms at six month and four-year follow-up (between-person change).
- During the intervention, expectations for positive effects of the intervention, will predict ED symptoms at the next week (within-person change).
- Who the instructor is, will predict pre-post changes in outcome. For each within-person hypothesis, the reverse effects will also be examined.
Qualitative part of study:
A randomly selected sub-group of 20 participants will be interviewed about their experiences during and after the intervention.
Statistical Analysis Plan These longitudinal data will be disaggregated so that within- and between-person effects can be studied separately Repeated measurements like the present one typically has drop-outs and missing data. Therefore, we will use mixed models instead of paired t-tests, repeated measures ANOVAs, and ordinary linear regression to analyze the data. Mixed models use maximum likelihood estimation, which is the state-of-the-art approach to handle missing data (Schafer \& Graham, 2002). Especially if data are missing at random, which is likely in our study, mixed models give more unbiased results than the other analytic methods.
In preliminary analyses, and for each of the dependent variables (EDE-Q, subscales form Self-compassion Scale), the combination of random effects and covariance structure of residuals that gives the best fit for the "empty" model (the model without fixed predictors except the intercept) will be chosen. Akaike's Information Criterion (AIC) will be used to compare the fit of different models. Models that give a reduction in AIC greater than 2 will be considered better (Burnham \& Anderson, 2004). The program SPSS version 28.0.1.1 (15) will be used.
Possible transformations:
All variables will be assessed in their original and validated format as is recommended practice, as long as this is possible with regards to statistical assumptions underlying the pre-defined analyses (i.e., multiple regression). However, if this is not possible with regards to the statistical assumptions behind the analyses, transformation (e.g., square root or log-transformations) may be needed to apply interval-based methods. The investigators will examine the degree of skewness and evaluate this against the assumptions and analyses before choosing the appropriate analysis. The pre-registered and planned analyses include multiple regression as long as assumptions are met. Alternatively, a non-parametric test will be used.
Inference criteria:
We pre-define the significance level: p < 0.05 to determine significance.
Missing data:
Maximum likelihood
- Conditions
- Eating Disorders
- Being tested
- Mindful Eating Conscious Living
- Keywords
- Eating Disorder, Mindfulness, Self-compassion, Longitudinal, Within-person, Long-term
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Eating Conscious LivingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | All participants receive the intervention Receives: Behavioral: Mindful Eating Conscious Living |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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".
Measured: 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
A self-report questionnaire developed by Framson et al asking respondents to indicate the extent to which they engage in mindful eating, e.g. with a nonjudgmental awareness of physical and emotional sensations associated with eating. Sample item: "I notice when there are subtle flavors in the foods I eat".
Measured: Pre, post, 6 months follow up, four-years follow-up
Change in relationship and life Satisfaction
Four items from the Norwegian directory of health's "minimum subjective check list"
Measured: Pre, post, 6 months follow up, four-years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start1 Oct 2022
- Primary completionAug 2026 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 197 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Modum Bad
- Responsible party
- Principal investigator, Ingrid Dundas, University of Bergen
- Investigators
- Ingrid Dundas, PhD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539807
- Sponsor's protocol ID
- REK353216
- Status last verified
- Jul 2025
- First submitted
- 24 Aug 2022
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified quantitative data will be shared.
Publications
Ohnstad A, Vrabel K, Danielsen YS, Binder PE, Dundas I. Self-compassion in flux: a four-year longitudinal study of intraindividual variations in self-compassion and disordered eating. J Eat Disord. 2026 Apr 19;14(1):143. doi: 10.1186/s40337-026-01605-x.
PubMed 42002810
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Long-term Changes in Eating Disorder Symptoms During and After a Low-threshold Mindfulness-based Intervention Administered by a Self-help Organization in Norway
- ClinicalTrials.gov ID
- NCT05539807
- Acronym / sponsor ID
- REK353216
- Conditions
- Eating Disorders
- Keywords
- Eating Disorder, Mindfulness, Self-compassion, Longitudinal, Within-person, Long-term
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 197 participants (estimated)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Modum Bad
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Recent literature-reviews suggest that mindfulness-based interventions may be effective in treating problems related to dysfunctional eating such as binge eating and emotional eating. Less is known about the processes through which change happens. Moreover, long-term follow-up is scarce. The main aim of the current project is to examine the role of self-kindness and self-judgement in predicting changes in eating disorder symptoms four years after, and to analyze longitudinal data for the entire project. Measures were administrated before the intervention, each week during the intervention, after the intervention, at follow-up 6 months after the intervention and at a second follow up four years after the intervention.
The intervention is an 8-week mindfulness-based eating program (Mindful Eating Conscious Living). This intervention was administered by a nation-wide Norwegian self-help eating disorder organization. Participants who enrolled in the program (N=197) were asked to complete standardized self-report instruments at recruitment (T1), digitally during each of the 8-week sessions (T2-T9), after the intervention was completed (T10) and six months after the intervention was completed (T11).
The current study - a PhD project - will invite the same participants to complete the same measures four years after completing the program. This will provide a rich data set, collected over four years.
The main hypotheses are:
Self-kindness and self-judgment as predictors of ED symptoms
- During the intervention, self-kindness and self-judgment at a given week will predict eating disorder (ED) symptoms the following week (within-person).
- Level of self-kindness and self-judgement will predict the level of ED symptoms during the whole course (pre, each week during the intervention, post and four-year follow-up) (between-person).
- Pre-post changes in self-kindness and self-judgment will predict level of ED symptoms at six-month and four-year follow up (between-person changes)
Secondary hypotheses are:
- During the intervention, mindfulness (from the self-compassion scale) at a given week will predict ED symptoms the following week (within-person change) 5) Level of mindfulness will predict the level of ED symptoms during the whole course (pre, each week during the intervention, post and four-year follow-up) (between-person).
- Pre-post changes in mindfulness and mindful eating will predict changes in ED symptoms, and relationship and life-satisfaction, at six month and four-year follow-up (between-person changes).
- Pre-post changes in shame will predict changes in ED symptoms at six month and four-year follow-up (between-person change).
- During the intervention, expectations for positive effects of the intervention, will predict ED symptoms at the next week (within-person change).
- Who the instructor is, will predict pre-post changes in outcome. For each within-person hypothesis, the reverse effects will also be examined.
Qualitative part of study:
A randomly selected sub-group of 20 participants will be interviewed about their experiences during and after the intervention.
Statistical Analysis Plan These longitudinal data will be disaggregated so that within- and between-person effects can be studied separately Repeated measurements like the present one typically has drop-outs and missing data. Therefore, we will use mixed models instead of paired t-tests, repeated measures ANOVAs, and ordinary linear regression to analyze the data. Mixed models use maximum likelihood estimation, which is the state-of-the-art approach to handle missing data (Schafer \& Graham, 2002). Especially if data are missing at random, which is likely in our study, mixed models give more unbiased results than the other analytic methods.
In preliminary analyses, and for each of the dependent variables (EDE-Q, subscales form Self-compassion Scale), the combination of random effects and covariance structure of residuals that gives the best fit for the "empty" model (the model without fixed predictors except the intercept) will be chosen. Akaike's Information Criterion (AIC) will be used to compare the fit of different models. Models that give a reduction in AIC greater than 2 will be considered better (Burnham \& Anderson, 2004). The program SPSS version 28.0.1.1 (15) will be used.
Possible transformations:
All variables will be assessed in their original and validated format as is recommended practice, as long as this is possible with regards to statistical assumptions underlying the pre-defined analyses (i.e., multiple regression). However, if this is not possible with regards to the statistical assumptions behind the analyses, transformation (e.g., square root or log-transformations) may be needed to apply interval-based methods. The investigators will examine the degree of skewness and evaluate this against the assumptions and analyses before choosing the appropriate analysis. The pre-registered and planned analyses include multiple regression as long as assumptions are met. Alternatively, a non-parametric test will be used.
Inference criteria:
We pre-define the significance level: p < 0.05 to determine significance.
Missing data:
Maximum likelihood
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Mindful Eating Conscious LivingAll participants receive the intervention |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Self-identifying as having a binge-eating related problem and being 16 years or older.
Key exclusion criteria (1 listed)
- High suicidal risk, serious self-harm, active psychosis, active major depressive episode, anorexia nervosa, BMI < 18, or debilitating social anxiety.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful Eating Conscious LivingMECL 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. | Behavioural | Intervention |
Primary outcome
Change in eating disorder symptoms measured by Eating Disorder Examination Questionnaire (EDE-Q)
Time frame: Pre, weekly during treatment - 8 weeks, post, 6 months follow-up, four years follow-up
A self-report questionnaire measuring eating disorder symptoms by Fairburn and colleagues
Change in self-kindness, self-judgement and mindfulness from the Self-compassion scale
Time frame: Pre, weekly during treatment - 8 weeks, post, 6 months follow-up, four years follow-up
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".
2 secondary outcomes
Change in mindful eating as measured by the Mindful Eating Questionnaire
Time frame: Pre, post, 6 months follow up, four-years follow-up
Change in relationship and life Satisfaction
Time frame: Pre, post, 6 months follow up, four-years follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Derived from this study: PubMed 42002810Ohnstad A, Vrabel K, Danielsen YS, Binder PE, Dundas I. Self-compassion in flux: a four-year longitudinal study of intraindividual variations in self-compassion and disordered eating. J Eat Disord. 2026 Apr 19;14(1):143. doi: 10.1186/s40337-026-01605-x.
- Individual participant dataSharing planned: Yes. Deidentified quantitative data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ingrid Dundas, PhD principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Eating Conscious Living in people with Eating Disorders, run by University of Bergen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in eating disorder symptoms measured by Eating Disorder Examination Questionnaire (EDE-Q) (time frame: Pre, weekly during treatment - 8 weeks, post, 6 months follow-up, four years follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05539807, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.