Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents: a Randomized Controlled Trial With Long-term Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Changes in Binge eating behavior using the STOB-screening tool
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Camp staff have no knowledge of or influence on which parents/guardians are assigned to the parent-based BED intervention. Study staff performing the ChEDE after the camp intervention will be blinded to group assignment.
入排标准
- 年龄范围
- 7 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: A 10-week multicomponent camp intervention for children (Behavioral)
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.
干预措施: A 10-week multicomponent camp intervention for children (Behavioral)
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.
干预措施: A BED intervention for parents (Behavioral)
结局指标
主要结局
Changes in Binge eating behavior using the STOB-screening tool
时间窗: 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
Changes in Binge eating behavior using the STOB-screening tool
时间窗: Baseline, 10-weeks (post-intervention), 10-12 weeks after the intervention, and 2 and 5 years after the intervention.
The STOB-screening tool consist of five yes/no questions + one question about number of overeating episodes
Changes in prevalence of Binge eating disorder (BED) using the ChEDE
时间窗: Baseline, and 10-weeks (post-intervention).
Binge eating disorder will be assessed using the Child Eating Disorder Examination interview
次要结局
- Changes in Body Mass Index standard deviation score (BMI-SDS)(Baseline, 10-weeks (post-intervention), 10-12 weeks after the intervention, and 1, 3 and 5 years after the intervention.)
- Changes in Body fat (%)(Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.)
- Changes in Skeletal Muscle Mass (kg)(Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.)
- Changes in Skeletal Muscle Mass (kg)(Baseline, 10-weeks (post-intervention), and 2 and 5 years after the intervention.)
- Changes in Body Mass Index standard deviation score (BMI-SDS)(Baseline, 10-weeks (post-intervention), 10-12 weeks after the intervention, and 2 and 5 years after the intervention.)
- Changes in Body fat (%)(Baseline, 10-weeks (post-intervention), and 2 and 5 years after the intervention.)