WIN: a Feasibility Study of a Weight-Neutral Health Intervention. Lighthouse Consortium on Obesity Management (LightCOM) Trial no 1.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Primary feasibility outcome: completion of follow-up
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old at screening.
- •BMI ≥30 kg/m
- •Residence in the Capital Region of Denmark.
- •Able to understand and communicate in Danish.
- •Informed consent.
排除标准
- •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.
结局指标
主要结局
Primary feasibility outcome: completion of follow-up
时间窗: 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
次要结局
- Secondary feasibility outcome: fidelity end of intervention(After group session 11 (study week 23))
- Secondary feasibility outcome: recruitment proportion(Inclusion)
- Secondary feasibility outcome: fidelity midway(After group session 5 (study week 12))
研究者
Carsten Dirksen
Associate Professor
Copenhagen University Hospital, Hvidovre