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Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07301541
Acronym
STOB
Enrollment
200
Registered
2025-12-24
Start date
2027-01-01
Completion date
2036-01-01
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BED, Binge Eating, Binge Eating Disorder, Childhood Obesity, Children, Loss of Control Eating, Overweight , Obesity, Screening

Keywords

Binge eating, Binge eating disorder, Lifestyle intervention, Children, Loss of control eating, Adolescents, BED, Screening

Brief summary

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

BEHAVIORALA 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.

BEHAVIORALA 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.

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
7 Years to 14 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in Binge eating behavior using the STOB-screening toolBaseline, 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 prevalence of Binge eating disorder (BED) using the ChEDEBaseline, and 10-weeks (post-intervention).Binge eating disorder will be assessed using the Child Eating Disorder Examination interview

Secondary

MeasureTime frameDescription
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.BMI-SDS calculated using World Health Organization Anthro-Plus software/cutoffs to define normal weight, overweight and obesity among participants.
Changes in Body fat (%)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).
Changes in Skeletal Muscle Mass (kg)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).

Countries

Denmark

Contacts

CONTACTJens M Bruun, Professor
jens.bruun@clin.au.dk+45 50945547
CONTACTDorthe D Pauls, PhD
dorthedalstrup@clin.au.dk
PRINCIPAL_INVESTIGATORJens M Bruun, Professor

University of Aarhus

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026