ClinicalTrials.gg
Not yet recruitingNCT07301541STOBUpdated Nov 6, 2026

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

An interventional study of A 10-week multicomponent camp intervention for children and A BED intervention for parents in Binge Eating Disorder, Binge Eating and Loss of Control Eating, sponsored by University of Aarhus. Not yet recruiting at 2 sites in Denmark. Open to participants aged 7 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment

Updated Nov 6, 2026Primary outcomes revisedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
7 Years to 14 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Binge eating
  • Binge eating disorder
  • Lifestyle intervention
  • Children
  • Loss of control eating
  • Adolescents
  • BED
  • Screening
03

In context

Binge-Eating Disorder

233 studies on the registry are indexed under Binge-Eating Disorder; 53 are open to participants now.

This study's planned enrollment of 200 is above the median of 77 across 190 interventional studies indexed under Binge-Eating Disorder.

Browse Binge-Eating Disorder studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

Exclusion Criteria:

  • A medical condition affecting dietary intake and/or eating behavior
  • Taking weight loss medication
  • The parent/guardian don't understand the written
  • Participant or parent/guardian are unwilling to or unable to comply with the study protocol and instructions given by the study staff.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Active comparator
    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.

    Behavioral: A 10-week multicomponent camp intervention for children

  • Experimental
    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.

    Behavioral: A 10-week multicomponent camp intervention for children · Behavioral: A BED intervention for parents

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.

06

What researchers measure

Primary outcomes

  1. Changes in Binge eating behavior using the STOB-screening tool

    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.

    Time frame: Baseline, 10-weeks (post-intervention), 10-12 weeks after the intervention, and 1, 3 and 5 years after the intervention.

  2. Changes in prevalence of Binge eating disorder (BED) using the ChEDE

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

    Time frame: Baseline

Secondary outcomes

  1. Changes in Body Mass Index standard deviation score (BMI-SDS)

    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

    Time frame: Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.

  2. Changes in Body fat (%)

    Measured in light clothing without shoes using a Bioelectric impedance (InBody model 270, Hopkins Medical Products, Grand Rapids, MI, USA).

    Time frame: Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.

  3. Changes in Skeletal Muscle Mass (kg)

    Measured in light clothing without shoes using a Bioelectric impedance (InBody model 270, Hopkins Medical Products, Grand Rapids, MI, USA).

    Time frame: Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.

Other outcomes

  1. Changes in Quality of Life using the PedsQL

    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.

    Time frame: Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.

  2. Changes in appetitive traits using the CEBQ or AEBQ depending on age

    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.

    Time frame: Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.

  3. Change in eating disorder symptoms using EDE-QS

    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.

    Time frame: Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.

07

Study locations

2 sites
  • Julemærkehjemmet Hobro
    Hobro, 9500, Denmark
  • Julemærkehjemmet Fjordmark
    Kruså, 6340, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Primary outcomes
Revised in 2 updates
What changed on Oct 30, 2026
  • Time frameChanges in prevalence of Binge eating disorder (BED) using the ChEDEBaseline, and 10-weeks (post-intervention). → Baseline
What changed on Nov 6, 2026
  • DescriptionChanges in Binge eating behavior using the STOB-screening tool: how it is measured was reworded
across 2 updates, Oct 30, 2026 – Nov 6, 2026
Secondary outcomes
Revised in 2 updates
What changed on Oct 30, 2026
  • Time frameChanges 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. → Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.
  • Addedother outcomeChange in eating disorder symptoms using EDE-QSTime frame: Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.
  • Time frameother outcomeChanges in Quality of Life using the PedsQLBaseline, 10-weeks (post-intervention), 10-12 weeks after the intervention, and 1, 3 and 5 years after the intervention. → Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.
  • Time frameother outcomeChanges in appetitive traits using the CEBQ or AEBQ depending on ageBaseline, 10-weeks (post-intervention), 10-12 weeks after the intervention, and 1, 3 and 5 years after the intervention. → Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.
What changed on Nov 6, 2026
  • DescriptionChanges in Body Mass Index standard deviation score (BMI-SDS): how it is measured was reworded
  • Descriptionother outcomeChange in eating disorder symptoms using EDE-QS: how it is measured was reworded
  • Descriptionother outcomeChanges in Quality of Life using the PedsQL: how it is measured was reworded
  • Descriptionother outcomeChanges in appetitive traits using the CEBQ or AEBQ depending on age: how it is measured was reworded
across 2 updates, Oct 30, 2026 – Nov 6, 2026
Show all 2 updates
  1. Nov 6, 2026
    Primary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionChanges in Binge eating behavior using the STOB-screening tool: how it is measured was reworded
    Secondary outcomes 4 description edited
    What changed in the outcomes
    • DescriptionChanges in Body Mass Index standard deviation score (BMI-SDS): how it is measured was reworded
    • Descriptionother outcomeChange in eating disorder symptoms using EDE-QS: how it is measured was reworded
    • Descriptionother outcomeChanges in Quality of Life using the PedsQL: how it is measured was reworded
    • Descriptionother outcomeChanges in appetitive traits using the CEBQ or AEBQ depending on age: how it is measured was reworded
  2. Oct 30, 2026
    Primary outcomes 1 time frame changed
    What changed in the outcomes
    • Time frameChanges in prevalence of Binge eating disorder (BED) using the ChEDEBaseline, and 10-weeks (post-intervention). → Baseline
    Secondary outcomes 3 time frame changed, 1 added
    What changed in the outcomes
    • Time frameChanges 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. → Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.
    • Addedother outcomeChange in eating disorder symptoms using EDE-QSTime frame: Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.
    • Time frameother outcomeChanges in Quality of Life using the PedsQLBaseline, 10-weeks (post-intervention), 10-12 weeks after the intervention, and 1, 3 and 5 years after the intervention. → Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.
    • Time frameother outcomeChanges in appetitive traits using the CEBQ or AEBQ depending on ageBaseline, 10-weeks (post-intervention), 10-12 weeks after the intervention, and 1, 3 and 5 years after the intervention. → Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07301541
Responsible party
Sponsor
First posted
Dec 24, 2025
Start date
Jan 2027 (estimated)
Primary completion
Dec 2028 (estimated)
Completion
Jan 2036 (estimated)
Last update
Nov 6, 2026

Study contacts

Jens M Bruun, Professor
Contact
jens.bruun@clin.au.dk
+45 50945547
Dorthe D Pauls, PhD
Contact
dorthedalstrup@clin.au.dk
Jens M Bruun, Professor
principal investigator · University of Aarhus

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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