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

NCT06922630 | Active Not Recruiting

• 2 other identifiers: WIN feasibility studyNNF22SA0080921
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Secondary feasibility outcome: recruitment proportion

  Inclusion

• Secondary feasibility outcome: fidelity midway

  After group session 5 (study week 12)

• Secondary feasibility outcome: fidelity end of intervention

  After group session 11 (study week 23)

Other Outcomes (39)

• Exploratory feasibility outcomes: Completion of follow-up, individual questionnaires

  End of study (week 24)

• Exploratory feasibility outcomes: Completion of follow-up, blood samples

  End of study (week 24)

• Exploratory feasibility outcomes: Completion of follow-up, hair samples

  End of study (week 24)

Study Arms (1)

WIN

EXPERIMENTAL

Weight-neutral health intervention

Behavioral: WIN

Interventions

WIN BEHAVIORAL

Weight-neutral health intervention

WIN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carsten Dirksen: lead
• University of Copenhagen: collaborator
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator

Study Sites (1)

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

Copenhagen, Denmark

Location

Related Links

• LightCOM website

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carsten Dirksen, Ass. Professor

  Hvidovre University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 10, 2025
• Study Start: August 7, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: When the results have been published
• Access Criteria: Researchers with a protocol for their planned study

Locations

DK (1)