ObesityWINNCT06922630
WIN: a Feasibility Study of a Weight-Neutral Health Intervention
A study testing WIN in people with Obesity, run by Carsten Dirksen at 1 site in Denmark.
Trial summary
The WIN intervention aims to improve the mental, social and physical health as well as quality of life of participants with BMI≥30 without focusing on their weight, and with no aim of weight loss. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- WIN
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Aug 2025to 31 Dec 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old at screening.
- BMI ≥30 kg/m2.
- Residence in the Capital Region of Denmark.
- Able to understand and communicate in Danish.
- Informed consent.
Who cannot join
- Intends to become pregnant during the intervention or is currently pregnant.
- Has used weight loss medications or GLP-1 agonist treatment within the past 6 months or intends to use weight loss medications or begin any other intensive weight loss treatment during the WIN intervention.
- Has severe psychiatric or physical conditions that may interfere with participation or may present a safety concern.
- Cannot transport themselves to the group sessions.
- Is deemed unable to complete a two-hour group session, as assessed by the investigator at the clinical screening interview.
- Takes part in other research involving weight loss treatment that would compromise participation in this study.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Research Unit for General Practice and Section of General Medicine, Department of Public Health, University of Copenhagen
Copenhagen
About this study
Official title: WIN: a Feasibility Study of a Weight-Neutral Health Intervention. Lighthouse Consortium on Obesity Management (LightCOM) Trial no 1.
The WIN intervention aims to improve the mental, social and physical health as well as quality of life of participants with BMI≥30 without focusing on their weight, and with no aim of weight loss. The WIN 6 months intervention is based on the principles and methods of the weight neutral movement Health at Every Size (HAES). The content is developed in a co-design process that involved Danish participants who have lived or professional experiences with such approaches.
The intervention uses the method of intuitive eating to align eating behaviours with internal cues of hunger and fullness rather than rules, restrictions and external cues. The intervention also draws on components from Acceptance and Commitment Therapy (ACT) to manage body image concerns and weight stigma.
Read the detailed description
The WIN group intervention comprises bi-weekly two-hour sessions with 11-12 participants and two WIN-therapists. Session 1 is an individual session and sessions 2-12 are group sessions. The programmes include psychoeducation, group discussions and homework about topics within the weight neutral approach such as intuitive eating, weight stigma, enjoyable movement and self-compassion.
Overview of sessions 1-12:
- Individual session with a WIN therapist to explore the participant's expectations and needs in relation to commencing intuitive eating and body acceptance.
- Introduction to weight-neutral health
- Your body, Your rules
- Intuitive eating I
- Intuitive eating II
- Body Respect and Weight Stigmatization
- Self-compassion and confronting your inner critical voice
- Body awareness, Rest and Movement - Yoga and Your strong body
- Body awareness, Rest and Movement, intimacy and sexuality
- Follow-up on intuitive eating
- Follow-up on challenges
- Strategies for resilience
Optional WIN elements include two support network events, up to 24 2-hour sessions of WIN-physical activity (Rest and Movement (12 sessions) and Competent Body Training (12 sessions)), and three individual online sessions.
- Conditions
- Obesity
- Being tested
- WIN
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WINBehavioural
Weight-neutral health intervention
| Study group | Role | What they receive |
|---|---|---|
| WIN | Experimental | Weight-neutral health intervention Receives: Behavioral: WIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary feasibility outcome: completion of follow-up
The proportion of participants who complete the follow-up examination, defined as answering the 'Mental health component' of the 36-item Short Form survey
Measured: 24 weeks after inclusion
Secondary outcomes (3)
Secondary feasibility outcome: recruitment proportion
The proportion of people who are enrolled as participants (numerator, n) out of all those who passed the initial telephone screening (denominator, N).
Measured: Inclusion
Secondary feasibility outcome: fidelity midway
Proportion of sessions attended by participants compared to the total number of sessions available
Measured: After group session 5 (study week 12)
Secondary feasibility outcome: fidelity end of intervention
Proportion of sessions attended by participants compared to the total number of sessions available
Measured: After group session 11 (study week 23)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start7 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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 ObesityStudies 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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carsten Dirksen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Copenhagen Trial Unit, Center for Clinical Intervention Research
- Responsible party
- Sponsor-investigator, Carsten Dirksen, Copenhagen University Hospital, Hvidovre
- Investigators
- Carsten Dirksen, Ass. Professor, Study chair, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922630
- Sponsor's protocol ID
- WIN feasibility study
- Other IDs
- NNF22SA0080921
- Acronym
- WIN
- Status last verified
- Nov 2025
- First submitted
- 3 Apr 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the results have been published, the aim is to make a depersonalised dataset publicly available on e.g. ClinicalTrials.gov and/or the European Union (EU) Zenodo database (https://zenodo.org/). The final choice will reflect which platform(s) that are compliant with current legislation at that time.
Publications
Sigurdardottir GA, Koster-Rasmussen R, Meyer LB, Sandholdt CT, Christiansen AL, Specht IO, Lindschou J, Engstrom J, Heitmann BL, Bojsen-Moller KN, Overbeck G, Kousgaard MB, Reventlow S, Jebb S, Dirksen C, Aveyard P, Waldorff FB; LightCOM team. Weight-Neutral Health Intervention (WIN) for adults with BMI >/=30 kg/m2: protocol for a single-arm feasibility study. BMJ Open. 2026 May 26;16(5):e116962. doi: 10.1136/bmjopen-2026-116962.
PubMed 42191203
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WIN: a Feasibility Study of a Weight-Neutral Health Intervention. Lighthouse Consortium on Obesity Management (LightCOM) Trial no 1.
- ClinicalTrials.gov ID
- NCT06922630
- Acronym / sponsor ID
- WIN / WIN feasibility study
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Carsten DirksenUniversity, hospital or other
- Collaborators
- University of Copenhagen, Copenhagen Trial Unit, Center for Clinical Intervention Research
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Apr 2025 (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.
The WIN intervention aims to improve the mental, social and physical health as well as quality of life of participants with BMI≥30 without focusing on their weight, and with no aim of weight loss. The WIN 6 months intervention is based on the principles and methods of the weight neutral movement Health at Every Size (HAES). The content is developed in a co-design process that involved Danish participants who have lived or professional experiences with such approaches.
The intervention uses the method of intuitive eating to align eating behaviours with internal cues of hunger and fullness rather than rules, restrictions and external cues. The intervention also draws on components from Acceptance and Commitment Therapy (ACT) to manage body image concerns and weight stigma.
Detailed description
The WIN group intervention comprises bi-weekly two-hour sessions with 11-12 participants and two WIN-therapists. Session 1 is an individual session and sessions 2-12 are group sessions. The programmes include psychoeducation, group discussions and homework about topics within the weight neutral approach such as intuitive eating, weight stigma, enjoyable movement and self-compassion.
Overview of sessions 1-12:
- Individual session with a WIN therapist to explore the participant's expectations and needs in relation to commencing intuitive eating and body acceptance.
- Introduction to weight-neutral health
- Your body, Your rules
- Intuitive eating I
- Intuitive eating II
- Body Respect and Weight Stigmatization
- Self-compassion and confronting your inner critical voice
- Body awareness, Rest and Movement - Yoga and Your strong body
- Body awareness, Rest and Movement, intimacy and sexuality
- Follow-up on intuitive eating
- Follow-up on challenges
- Strategies for resilience
Optional WIN elements include two support network events, up to 24 2-hour sessions of WIN-physical activity (Rest and Movement (12 sessions) and Competent Body Training (12 sessions)), and three individual online sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WIN | Experimental | Behavioral: WINWeight-neutral health intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years old at screening.
- BMI ≥30 kg/m2.
- Residence in the Capital Region of Denmark.
- Able to understand and communicate in Danish.
- Informed consent.
Key exclusion criteria (6 listed)
- Intends to become pregnant during the intervention or is currently pregnant.
- Has used weight loss medications or GLP-1 agonist treatment within the past 6 months or intends to use weight loss medications or begin any other intensive weight loss treatment during the WIN intervention.
- Has severe psychiatric or physical conditions that may interfere with participation or may present a safety concern.
- Cannot transport themselves to the group sessions.
- Is deemed unable to complete a two-hour group session, as assessed by the investigator at the clinical screening interview.
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 |
|---|---|---|
| WINWeight-neutral health intervention | Behavioural | WIN |
Primary outcome
Primary feasibility outcome: completion of follow-up
Time frame: 24 weeks after inclusion
The proportion of participants who complete the follow-up examination, defined as answering the 'Mental health component' of the 36-item Short Form survey
3 secondary outcomes
Secondary feasibility outcome: recruitment proportion
Time frame: Inclusion
Secondary feasibility outcome: fidelity midway
Time frame: After group session 5 (study week 12)
Secondary feasibility outcome: fidelity end of intervention
Time frame: After group session 11 (study week 23)
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 4 Dec 2025.
- Derived from this study: PubMed 42191203Sigurdardottir GA, Koster-Rasmussen R, Meyer LB, Sandholdt CT, Christiansen AL, Specht IO, Lindschou J, Engstrom J, Heitmann BL, Bojsen-Moller KN, Overbeck G, Kousgaard MB, Reventlow S, Jebb S, Dirksen C, Aveyard P, Waldorff FB; LightCOM team. Weight-Neutral Health Intervention (WIN) for adults with BMI >/=30 kg/m2: protocol for a single-arm feasibility study. BMJ Open. 2026 May 26;16(5):e116962. doi: 10.1136/bmjopen-2026-116962.
- LightCOM websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. After the results have been published, the aim is to make a depersonalised dataset publicly available on e.g. ClinicalTrials.gov and/or the European Union (EU) Zenodo database (https://zenodo.org/). The final choice will reflect which platform(s) that are compliant with current legislation at that time.
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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. This study is not recruiting at the moment.
Carsten Dirksen, Ass. Professor study chair
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WIN in people with Obesity, run by Carsten Dirksen at 1 site in Denmark.
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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 4 Dec 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 Denmark. 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?
Primary feasibility outcome: completion of follow-up (time frame: 24 weeks after inclusion). 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 NCT06922630, 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 4 Dec 2025.