Clinical trial NCT06922630: WIN: a Feasibility Study of a Weight-Neutral Health Intervention
Official title: WIN: a Feasibility Study of a Weight-Neutral Health Intervention. Lighthouse Consortium on Obesity Management (LightCOM) Trial no 1.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Copenhagen Trial Unit, Center for Clinical Intervention Research
First posted: 2025-04-10
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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:

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary feasibility outcome: completion of follow-up
timeFrame: 24 weeks after inclusion
Secondary outcomes:
measure: Secondary feasibility outcome: recruitment proportion
timeFrame: Inclusion
measure: Secondary feasibility outcome: fidelity midway
timeFrame: After group session 5 (study week 12)
measure: Secondary feasibility outcome: fidelity end of intervention
timeFrame: After group session 11 (study week 23)
Other outcomes:
measure: Other feasibility outcomes: Completion of follow-up, individual questionnaires
timeFrame: End of study (week 24)
measure: Other feasibility outcomes: Completion of follow-up, blood samples
timeFrame: End of study (week 24)
measure: Other feasibility outcomes: Completion of follow-up, hair samples
timeFrame: End of study (week 24)
measure: Other feasibility outcomes: Completion of follow-up, actigraphy
timeFrame: End of study (week 24)
measure: Other feasibility outcomes: Completion of follow-up, physical assessments
timeFrame: End of study (week 24)
measure: Other feasibility outcomes: Compliance and participant engagement, 'rest and movement'
timeFrame: End of study (week 24)
measure: Other feasibility outcomes: Compliance and participant engagement, 'competence and strength training'
timeFrame: End of study (week 24)
measure: Other feasibility outcomes: Compliance and participant engagement, 'support network events'
timeFrame: End of study (week 24)
measure: Other feasibility outcomes: Compliance and participant engagement, 'online sessions'
timeFrame: End of study (week 24)
measure: Exploratory clinical outcome, questionnaire: SF-36 mental component score
timeFrame: End of study (week 24)
measure: Exploratory clinical outcome, questionnaire: SF-36 physical component score
timeFrame: End of study (week 24)
measure: Exploratory clinical outcome, questionnaire: SF-36 subscales
timeFrame: End of study (week 24)
measure: Exploratory clinical outcome, questionnaire: Mental health - WBIS-M
timeFrame: End of study (week 24)
measure: Exploratory clinical outcome, questionnaire: Intuitive Eating Scale - IES-3
timeFrame: End of study (week 24)
measure: Exploratory clinical outcome, questionnaire: Mental health - EDE-Q
timeFrame: End of study (week 24)
measure: Exploratory clinical outcome, questionnaire: Rosenberg Self-Esteem Scale
timeFrame: End of study (week 24)
measure: Exploratory clinical outcome, questionnaire: Body Appreciation Scale 2
timeFrame: End of study (week 24)
measure: Exploratory clinical outcome, questionnaire: Cantril Ladder Scale
timeFrame: End of study (week 24)
measure: Exploratory clinical outcome, questionnaire: Major Depression Inventory (MDI)
timeFrame: End of study (week 24)
measure: Exploratory clinical outcome, questionnaire: Perceived Stress Scale (PSS-10)
timeFrame: End of study (week 24)
measure: Exploratory clinical outcome: physical activity, SENS
timeFrame: End of study (week 24)
measure: Exploratory clinical outcome: sleep, SENS
timeFrame: End of study (week 24)
measure: Exploratory clinical outcome: chronic stress
timeFrame: End of study (week 24)
measure: Exploratory clinical outcome, physical assessment: blood pressure
timeFrame: End of study (week 24)
measure: Exploratory clinical outcome, physical assessment: pulse
timeFrame: End of study (week 24)
measure: Exploratory clinical outcome, physical assessment: weight
timeFrame: End of study (week 24)
measure: Exploratory clinical outcome: Hb1Ac
timeFrame: End of study (week 24)
measure: Exploratory clinical outcome: lipids
timeFrame: End of study (week 24)
measure: Exploratory clinical outcome: creatinine
timeFrame: End of study (week 24)
measure: Exploratory clinical outcome: eGRF
timeFrame: End of study (week 24)
measure: Exploratory clinical outcome: hsCRP
timeFrame: End of study (week 24)
measure: Exploratory clinical outcome: ALAT
timeFrame: End of study (week 24)
measure: Exploratory clinical outcome: TSH
timeFrame: End of study (week 24)
measure: Exploratory clinical outcome: Sodium
timeFrame: End of study (week 24)
measure: Exploratory clinical outcome: Potassium
timeFrame: End of study (week 24)
measure: Exploratory clinical outcome: Haemoglobin
timeFrame: End of study (week 24)
measure: Exploratory clinical outcome: vitamin D
timeFrame: End of study (week 24)
measure: Exploratory clinical outcome: serious adverse event
timeFrame: End of study (week 24)
Locations:
city: Copenhagen
country: Denmark
facility: Research Unit for General Practice and Section of General Medicine, Department of Public Health, University of Copenhagen
Study officials:
affiliation: Hvidovre University Hospital
name: Carsten Dirksen, Ass. Professor
role: STUDY_CHAIR
References: