NCT07301541

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
110mo left

Started Jan 2027

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 24, 2025

Completed
1 year until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

7.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2036

Last Updated

April 13, 2026

Status Verified

November 1, 2025

Enrollment Period

1.9 years

First QC Date

November 28, 2025

Last Update Submit

April 7, 2026

Conditions

Keywords

Binge eatingBinge eating disorderLifestyle interventionChildrenLoss of control eatingAdolescentsBEDScreening

Outcome Measures

Primary Outcomes (2)

  • 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

    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

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

    Baseline, and 10-weeks (post-intervention).

Secondary Outcomes (3)

  • 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.

Other Outcomes (2)

  • Changes in Quality of Life using the PedsQL

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

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

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

Study Arms (2)

Standard parent involvement during camp (P-ST)

ACTIVE COMPARATOR

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

Add-on parent-based BED intervention during camp (P-BED)

EXPERIMENTAL

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 childrenBehavioral: A BED intervention for parents

Interventions

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

Add-on parent-based BED intervention during camp (P-BED)

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

Add-on parent-based BED intervention during camp (P-BED)Standard parent involvement during camp (P-ST)

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Attending the camp in Hobro or Fjordmark from January 2027 to December 2027
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Julemærkehjemmet Hobro

Hobro, 9500, Denmark

Location

Julemærkehjemmet Fjordmark

Kruså, 6340, Denmark

Location

MeSH Terms

Conditions

Binge-Eating DisorderBulimiaOverweightObesityPediatric Obesity

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersHyperphagiaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Study Officials

  • Jens M Bruun, Professor

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jens M Bruun, Professor

CONTACT

Dorthe D Pauls, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2025

First Posted

December 24, 2025

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

January 1, 2036

Last Updated

April 13, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations