WIN: a Feasibility Study of a Weight-Neutral Health Intervention (WIN)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity
• Intervention / Treatment: Behavioral: WIN

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:

1. Individual session with a WIN therapist to explore the participant's expectations and needs in relation to commencing intuitive eating and body acceptance.
2. Introduction to weight-neutral health
3. Your body, Your rules
4. Intuitive eating I
5. Intuitive eating II
6. Body Respect and Weight Stigmatization
7. Self-compassion and confronting your inner critical voice
8. Body awareness, Rest and Movement - Yoga and Your strong body
9. Body awareness, Rest and Movement, intimacy and sexuality
10. Follow-up on intuitive eating
11. Follow-up on challenges
12. 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 Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Research Unit for General Practice and Section of General Medicine, Department of Public Health, University of Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WIN; Weight-neutral health intervention	Behavioral: WIN; Weight-neutral health intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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): physical functioning,; role limitations due to physical health problems,; bodily pain,; general health,; vitality (energy or fatigue),; social functioning,; role limitations due to emotional problems,; mental health (psychological distress and psychological well-being).	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 one´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)
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	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)

Collaborators and Investigators

• Sponsor: Carsten Dirksen
• Collaborators: University of Copenhagen; Copenhagen Trial Unit, Center for Clinical Intervention Research
• Investigators: Study Chair: Carsten Dirksen, Ass. Professor, Hvidovre University Hospital

Publications and helpful links

Helpful Links

• LightCOM website

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 3, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: WIN feasibility study; NNF22SA0080921 (Other Grant/Funding Number: Novo Nordisk Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: When the results have been published
• IPD Sharing Access Criteria: Researchers with a protocol for their planned study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No