Binge Eating DisorderSTOBNCT07301541
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
A study testing A 10-week multicomponent camp intervention for children and A BED intervention for parents in people with Binge Eating Disorder and Binge Eating, run by University of Aarhus at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Binge Eating Disorder, Binge Eating, Loss of Control Eating
- What is being tested?
- A 10-week multicomponent camp intervention for children and A BED intervention for parents
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesDenmark
- Study dates
- Jan 2027to Jan 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Dorthe D Pauls, PhD contact
Denmark2 sites
Julemærkehjemmet Hobro
Hobro, 9500
Julemærkehjemmet Fjordmark
Kruså, 6340
About this study
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
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.
- Conditions
- Binge Eating Disorder, Binge Eating, Loss of Control Eating, Overweight , Obesity, Children, Childhood Obesity
- Being tested
- A 10-week multicomponent camp intervention for children, A BED intervention for parents
- Keywords
- Binge eating, Binge eating disorder, Lifestyle intervention, Children, Loss of control eating, Adolescents, BED, Screening
- Medical subject headings
- Binge-Eating Disorder, Bulimia, Overweight, Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A 10-week multicomponent camp intervention for childrenBehavioural
A 10-week multicomponent camp intervention for participating children only, focusing on social and physical activities, healthy meals, and daily physical activities.
A BED intervention for parentsBehavioural
An add-on virtual parent-based intervention providing knowledge about BED and tools to support their child's eating after the multicomponent camp intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: A 10-week multicomponent camp intervention for children; Behavioral: A BED intervention for parents |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline, and 10-weeks (post-intervention).
Secondary outcomes (3)
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.
Measured: Baseline, 10-weeks (post-intervention), 10-12 weeks after the intervention, and 1, 3 and 5 years after the intervention.
Changes in Body fat (%)
Measured in light clothing without shoes using a Bioelectric impedance (InBody model 270, Hopkins Medical Products, Grand Rapids, MI, USA).
Measured: Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.
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).
Measured: Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study startJan 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJan 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge Eating DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens M Bruun, Professor, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301541
- Sponsor's protocol ID
- STOB 2.0
- Other IDs
- Journal number 05-0801-2595
- Acronym
- STOB
- Status last verified
- Nov 2025
- First submitted
- 28 Nov 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07301541
- Acronym / sponsor ID
- STOB / STOB 2.0
- Conditions
- Binge Eating Disorder, Binge Eating, Loss of Control Eating, Overweight , Obesity, Children, Childhood Obesity
- Keywords
- Binge eating, Binge eating disorder, Lifestyle intervention, Children, Loss of control eating, Adolescents, BED, Screening
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jan 2036 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard parent involvement during camp (P-ST) | Active comparator | Behavioral: A 10-week multicomponent camp intervention for childrenParents 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. |
| Add-on parent-based BED intervention during camp (P-BED) | Experimental | Behavioral: A 10-week multicomponent camp intervention for children, Behavioral: A BED intervention for parentsIn 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. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A 10-week multicomponent camp intervention for childrenA 10-week multicomponent camp intervention for participating children only, focusing on social and physical activities, healthy meals, and daily physical activities. | Behavioural | Add-on parent-based BED intervention during camp (P-BED), Standard parent involvement during camp (P-ST) |
| A BED intervention for parentsAn add-on virtual parent-based intervention providing knowledge about BED and tools to support their child's eating after the multicomponent camp intervention. | Behavioural | Add-on parent-based BED intervention during camp (P-BED) |
Primary outcome
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.
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
Time frame: Baseline, and 10-weeks (post-intervention).
Binge eating disorder will be assessed using the Child Eating Disorder Examination interview
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Binge Eating Disorder
Not yet recruiting
FUS Neuromodulation for Binge Eating Disorder
Binge-Eating Disorder
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
RecruitingObservational study
Children s Growth and Behavior Study
Obesity, Eating Behaviors
Not yet recruiting
Cognitive and Behavioral Approaches to Reduce Binge Eating and Excess Weight in Adolescents (Online)
Binge Eating, Overweight and Obesity
Active, not recruitingEarly Phase 1
Naltrexone Neuroimaging in Teens With Eating Disorders
Eating Disorders, Binge Eating
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dorthe D Pauls, PhD contact
Jens M Bruun, Professor principal investigator
University of Aarhus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A 10-week multicomponent camp intervention for children and A BED intervention for parents in people with Binge Eating Disorder and Binge Eating, run by University of Aarhus at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jens M Bruun, Professor (+45 50945547, jens.bruun@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.