Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: A 10-week multicomponent camp intervention for children, A BED intervention for parents.
- Who it may be relevant to
- Registry conditions: Binge Eating Disorder, Binge Eating, Loss of Control Eating, Overweight , Obesity. Basic parameters: 7 years — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
Interventions
- Behavioral 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. - Behavioral 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.
Primary outcome measures
- Changes in Binge eating behavior using the STOB-screening tool [Time frame: 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 [Time frame: Baseline, and 10-weeks (post-intervention).]
Secondary outcome measures (3)
- Changes in Body Mass Index standard deviation score (BMI-SDS) [Time frame: Baseline, 10-weeks (post-intervention), 10-12 weeks after the intervention, and 1, 3 and 5 years after the intervention.]
- Changes in Body fat (%) [Time frame: Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.]
- Changes in Skeletal Muscle Mass (kg) [Time frame: Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Denmark · 2 centers
- Julemærkehjemmet Hobro — Hobro
- Julemærkehjemmet Fjordmark — Kruså
Identifiers
NCT: NCT07301541 · STOB 2.0 · Journal number 05-0801-2595