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| ID | Type | Description | Link |
|---|---|---|---|
| NNF22SA0080921 | Other Grant/Funding Number | Novo Nordisk Foundation |
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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
| Copenhagen Trial Unit, Center for Clinical Intervention Research | OTHER |
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The WIN intervention aims to improve the mental, social and physical health as well as quality of life of participants with BMIā„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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WIN | Experimental | Weight-neutral health intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WIN | Behavioral | Weight-neutral health intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 weeks after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Inclusion |
| Secondary feasibility outcome: fidelity midway |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory feasibility outcomes: Completion of follow-up, individual questionnaires | Proportion of participants that complete all questionnaires required in CID1 and CID2, see list below (all outcomes specified as 'exploratory clinical outcome, questionnaire') | End of study (week 24) |
| Exploratory feasibility outcomes: Completion of follow-up, blood samples |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carsten Dirksen, Ass. Professor | Hvidovre University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Unit for General Practice and Section of General Medicine, Department of Public Health, University of Copenhagen | Copenhagen | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42191203 | Derived | 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. |
| Label | URL |
|---|---|
| LightCOM website | View source |
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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.
When the results have been published
Researchers with a protocol for their planned study
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Proportion of sessions attended by participants compared to the total number of sessions available |
| 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 | After group session 11 (study week 23) |
Proportion of participants willing to give blood samples at both CID1 and CID2 |
| End of study (week 24) |
| Exploratory feasibility outcomes: Completion of follow-up, hair samples | Proportion of participants willing to give hair samples at both CID1 and CID2 | End of study (week 24) |
| Exploratory feasibility outcomes: Completion of follow-up, actigraphy | Proportion of participants willing to wear an actigraphy measuring physical activity. Assessed as the proportion of participants willing to wear and returning the SENS monitor after both CID1 and CID2. | End of study (week 24) |
| Exploratory feasibility outcomes: Completion of follow-up, physical assessments | Proportion of participants participating in the physical assessments in both CID1 and CID2, see list below (all outcomes specified as 'exploratory clinical outcome, physical assessment') | End of study (week 24) |
| Exploratory feasibility outcomes: Compliance and participant engagement, 'rest and movement' | Proportion of participants participating in at least one of the optional sessions 'rest and movement' | End of study (week 24) |
| Exploratory feasibility outcomes: Compliance and participant engagement, 'competence and strength training' | Proportion of participants participating in at least one of the optional sessions 'competence and strength training' | End of study (week 24) |
| Exploratory feasibility outcomes: Compliance and participant engagement, 'support network events' | Proportion of participants participating in at least one of the optional 'support network events' | End of study (week 24) |
| Exploratory feasibility outcomes: Compliance and participant engagement, 'online sessions' | Proportion of participants who attends at least one online session with the WIN-group therapist | End of study (week 24) |
| Exploratory clinical outcome, questionnaire: SF-36 mental component score | Quality of life, Short Form 36, mental component score (scale from 0-100, higher scores indicate better mental health) | End of study (week 24) |
| Exploratory clinical outcome, questionnaire: SF-36 physical component score | Quality of life, Short Form 36, physical component score (scale from 0-100, higher scores indicate better mental health) | End of study (week 24) |
| Exploratory clinical outcome, questionnaire: SF-36 subscales | Quality of life, Short Form 36, individual domains (scales from 0-100, higher scores indicate better mental health):
| End of study (week 24) |
| Exploratory clinical outcome, questionnaire: Mental health - WBIS-M | Weight Bias Internalization Scale (WBIS-M) score (scale from 1-7, higher scores indicate higher degree of internalized weight bias) | End of study (week 24) |
| Exploratory clinical outcome, questionnaire: Intuitive Eating Scale - IES-3 | Intuitive Eating Scale measuring participants' ability to rely on internal hunger and satiety cues, reject dieting mentally, and approach eating with body respect. 12 items, each scored 1-5. Minimum value 12, maximum value 60. Higher score reflects more intuitive eating (better outcome). | End of study (week 24) |
| Exploratory clinical outcome, questionnaire: Mental health - EDE-Q | Eating Disorder Examination Questionnaire (EDE-Q) score (scale from 0 to 6, higher scores indicate higher degree of eating disorder) | End of study (week 24) |
| Exploratory clinical outcome, questionnaire: Rosenberg Self-Esteem Scale | Rosenberg Self-Esteem Scale, measuring self-esteem levels as a psychological marker of well-being. 10 items, each scored 1-4. Minimum value 10, maximum value 40. Higher scores indicate higher self-esteem (better outcome). | End of study (week 24) |
| Exploratory clinical outcome, questionnaire: Body Appreciation Scale 2 | Body Appreciation Scale 2 (BAS-2), assessing positive body image, focusing on body acceptance and appreciation. 10 items, each scored 1-5. Minimum value 10, maximum value 50. Higher score indicates higher body appreciation (better outcome). | End of study (week 24) |
| Exploratory clinical outcome, questionnaire: Cantril Ladder Scale | Cantril Ladder Scale, providing a subjective measure of life satisfaction and well-being. Range: 0-10. A ladder stretching from 0 at the bottom (worst possible situation) to 10 at the top (best possible situation). Higher score indicates a more positive evaluation of oneĀ“s life (better outcome). | End of study (week 24) |
| Exploratory clinical outcome, questionnaire: Major Depression Inventory (MDI) | Major Depression Inventory (MDI) (scale from 0-50, higher scores indicate more symptoms of depression) | End of study (week 24) |
| Exploratory clinical outcome, questionnaire: Perceived Stress Scale (PSS-10) | Perceived Stress Scale (PSS-10), measures perceived stress over the past month. 10 items, each scored 0-4. Minimum value 0, maximum value 40. Higher scores indicating higher perceived stress (worse outcome). (Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.) | End of study (week 24) |
| Exploratory clinical outcome: physical activity, SENS | Assessed with activity tracker (SENS), measuring daily movement and exercise patterns (hours/day) | End of study (week 24) |
| Exploratory clinical outcome: sleep, SENS | Sleep duration using SENS Motion accelerometers (hours/day) | End of study (week 24) |
| Exploratory clinical outcome: chronic stress | Chronic stress (hair cortisol as a biomarker of long-term stress exposure) | End of study (week 24) |
| Exploratory clinical outcome, physical assessment: blood pressure | Systolic and diastolic blood pressure (mmHg) | End of study (week 24) |
| Exploratory clinical outcome, physical assessment: pulse | Pulse rate (beats per minute) | End of study (week 24) |
| Exploratory clinical outcome, physical assessment: weight | Weight (kg) | End of study (week 24) |
| Exploratory clinical outcome: Hb1Ac | Haemoglobin A1c (mmol/mol) | End of study (week 24) |
| Exploratory clinical outcome: lipids | Lipid profile (HDL, LDL, VLDL, total cholesterol and triglycerides) (mmol/L) | End of study (week 24) |
| Exploratory clinical outcome: creatinine | Creatinine (umol/L) | End of study (week 24) |
| Exploratory clinical outcome: eGRF | Estimated Glomerular Filtration Rate (eGFR) (mL/min/1.73^2) | End of study (week 24) |
| Exploratory clinical outcome: hsCRP | High-sensitivity C-reactive protein (hsCRP), mg/L | End of study (week 24) |
| Exploratory clinical outcome: ALAT | Alanine aminotransferase (ALAT) (unit per liter) | End of study (week 24) |
| Exploratory clinical outcome: TSH | Thyroid-stimulating hormone (x10^-3 IU/L) | End of study (week 24) |
| Exploratory clinical outcome: Sodium | Sodium (mmol/L) | End of study (week 24) |
| Exploratory clinical outcome: Potassium | Potassium (mmol/L) | End of study (week 24) |
| Exploratory clinical outcome: Haemoglobin | Haemoglobin (mmol/L) | End of study (week 24) |
| Exploratory clinical outcome: vitamin D | 25-OH vitamin D (nmol/L) | End of study (week 24) |
| Exploratory clinical outcome: serious adverse event | Proportion of participants that experienced at least one serious adverse event (according to ICH-GCP guidelines) | End of study (week 24) |
| Other feasibility outcomes: Completion of follow-up, individual questionnaires | Proportion of participants that complete all questionnaires required in CID1 and CID2, see list below (all outcomes specified as 'exploratory clinical outcome, questionnaire') | End of study (week 24) |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |