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针对参加多组分营地干预（无论是否包含父母BED干预）的儿童和青少年进行暴食障碍筛查及BE行为洞察 (STOB)

2026年11月3日 更新者：University of Aarhus

暴食症早期检测筛查工具（STOB）的测试、验证与实施及对儿童和青少年暴食行为发展的见解——在含或不含家长暴食症干预的多组分营地干预项目中的研究

The main purpose is to investigate the effectiveness of a 10-week multicomponent camp intervention to reduce BE behavior in children and adolescents and explore in a randomized controlled setting if a parent-based BED-intervention has any add-on effect, attenuating the development of BE behavior in this sample. The study will include an initial follow-up assessment scheduled 10-12 weeks after camp completion and plans for long-term follow-up assessments one, three and five years after inclusion.

Overall, we hypothesize that the multicomponent camp intervention will effectively reduce BE behavior in children and adolescents. Furthermore, we hypothesize that participants whose parents are randomized to receive the parental BED intervention will show a lower prevalence of BE behavior one year after the camp intervention compared with children whose parents receive standard care.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

The study will be conducted by the research team in close collaboration with the organization behind the multicomponent camps and their staff (Julemærkefonden/Julemærkehjem Hobro and Fjordmark). The multicomponent camps are well-established non-governmental institutions focusing on improving health and well-being in 7-14-year-old children by providing a structured environment, including social and physical activities, healthy meals and daily physical activities. Children of all weight classes can be referred to attend the camps by their general practitioner due to overweight, obesity and/or psychological challenges e.g., loneliness, bullying and family-related challenges. All 7-14-year-olds attend the camp free of charge.

In the present study, all participants will receive standard care during the 10-weeks at the multicomponent camp, which follows national recommendations concerning diet and physical activity. All participants will be screened for BED with the STOB screening tool before the intervention. Among those participants who screen positive for BED with the STOB screening tool, parents/guardians will be randomized to receive either:

Standard parental involvement during the camp (P-ST).

or

A parental BED intervention in addition to the standard parental involvement during the camp (P-BED)

In all cases where BED is suspected at recruitment based on the STOB screening tool, participants will be referred to a diagnostic interview (The Child Eating Disorder Examination (ChEDE)) to determine if participants fulfill the diagnostic criteria for BED. The use of ChEDE at baseline and after the intervention is implemented to validate the STOB screening-tool for future use. Therefore, a subsample of participants screened negative at recruitment with the STOB screening-tool (i.e., no BE behavior) will also undergo a diagnostic interview.

Throughout the study, interviews will be conducted with a subsample of participants, parents, and camp staff. Participants and camp staff will be interviewed to gain insights into their perspectives of using the STOB screening-tool. Moreover, parents will be interviewed to include their perspectives in the developmental process and to gain insights into their interpretation of the content, format, and perceived value of the parental BED intervention.

研究类型

介入性

注册 (估计的)

200

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 丹麦
      • Hobro、丹麦、9500
        • Julemærkehjemmet Hobro
      • Kruså、丹麦、6340
        • Julemærkehjemmet Fjordmark

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

7年 至 14年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Attending the camp in Hobro or Fjordmark from January 2027 to December 2027
  • 7-14 years of age at recruitment
  • Participants must have written informed consent from parent/guardian before camp to participate
  • At least one parent/guardian submit written informed consent to participate in the study with their child

Exclusion Criteria:

  • A medical condition affecting dietary intake and/or eating behavior
  • Taking weight loss medication
  • The parent/guardian don't understand the written informed consent
  • Participant or parent/guardian are unwilling to or unable to comply with the study protocol and instructions given by the study staff.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器：Standard parent involvement during camp (P-ST)

Parents or guardians will receive the standard parental involvement during and in relation to their child's camp attendance. This includes individual meetings with camp staff and parental educational days focused on gaining insight into camp life, as well as participating in social and physical activities and cooking classes.
行为的：A 10-week multicomponent camp intervention for children

A 10-week multicomponent camp intervention for participating children only, focusing on social and physical activities, healthy meals, and daily physical activities.
实验性的：Add-on parent-based BED intervention during camp (P-BED)

In addition to the standard parental involvement (P-ST) during camp, parents/guardians will receive a virtual parent-based BED intervention during the 10-week their child attend camp. The intervention will be designed to provide knowledge about BED and tools to support their child's eating after the intervention.
行为的：A 10-week multicomponent camp intervention for children

A 10-week multicomponent camp intervention for participating children only, focusing on social and physical activities, healthy meals, and daily physical activities.

行为的：A BED intervention for parents

An add-on virtual parent-based intervention providing knowledge about BED and tools to support their child's eating after the multicomponent camp intervention.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Changes in Binge eating behavior using the STOB-screening tool
大体时间：Baseline, 10-weeks (post-intervention), 10-12 weeks after the intervention, and 1, 3 and 5 years after the intervention.

The STOB-screening tool consist of five yes/no questions + one question about number of overeating episodes.

A 'yes' response to either overeating or loss-of-control eating is considered a positive screening result.
Baseline, 10-weeks (post-intervention), 10-12 weeks after the intervention, and 1, 3 and 5 years after the intervention.
Changes in prevalence of Binge eating disorder (BED) using the ChEDE
大体时间：Baseline

Binge eating disorder will be assessed using the Child Eating Disorder Examination interview
Baseline

次要结果测量

结果测量
措施说明
大体时间
Changes in Body Mass Index standard deviation score (BMI-SDS)
大体时间：Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.

BMI-SDS calculated using World Health Organization Anthro-Plus software/cutoffs to define normal weight, overweight and obesity among participants.

Overweight: >+1SD (equivalent to BMI 25 kg/m2 at 19 years) Obesity: >+2SD (equivalent to BMI 30 kg/m2 at 19 years) Thinness: <-2SD Severe thinness: <-3SD
Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.
Changes in Body fat (%)
大体时间：Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.

Measured in light clothing without shoes using a Bioelectric impedance (InBody model 270, Hopkins Medical Products, Grand Rapids, MI, USA).
Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.
Changes in Skeletal Muscle Mass (kg)
大体时间：Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.

Measured in light clothing without shoes using a Bioelectric impedance (InBody model 270, Hopkins Medical Products, Grand Rapids, MI, USA).
Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.

其他结果措施

结果测量
措施说明
大体时间
Changes in Quality of Life using the PedsQL
大体时间：Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.

Quality of life (QoL) will be assessed using the Pediatric Quality of Life Inventory to assess total QoL, physical functioning, emotional functioning. social functioning, and school functioning.

Responses are scored on a 0-100 scale with higher scores indicating higher QoL.
Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.
Changes in appetitive traits using the CEBQ or AEBQ depending on age
大体时间：Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.

Appetitive traits will be measured using the Children's eating behavior questionnaire or Adult Eating behavior questionnaire depending on age to assess food responsiveness, emotional overeating/undereating, enjoyment of food, desire to drink, hunger, satiety responsiveness, slowness in eating, and food fussiness.

Responses are scored on a 1-5 scale, with higher scores indicating a greater tendency toward the behavior.
Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.
Change in eating disorder symptoms using EDE-QS
大体时间：Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.

Eating disorder symptoms will be measured using the Eating Disorder Examination Questionnaire - Short. Scores on each item range from "0" to "6", with higher scores indicating higher symptom levels.
Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Aarhus

调查人员

  • 首席研究员：Jens M Bruun, Professor、University of Aarhus

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年1月1日

初级完成 (估计的)

2028年12月1日

研究完成 (估计的)

2036年1月1日

研究注册日期

首次提交

2025年11月28日

首先提交符合 QC 标准的

2025年12月10日

首次发布 (实际的)

2025年12月24日

研究记录更新

最后更新发布 (实际的)

2026年11月6日

上次提交的符合 QC 标准的更新

2026年11月3日

最后验证

2025年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • STOB 2.0
  • Journal number 05-0801-2595 (其他赠款/资助编号：The Danish Health Authority)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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