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NCT Number: NCT07301541

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

A 10-week multicomponent camp intervention for children

Behavioral

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 parents

Behavioral

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 outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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.

    BMI-SDS calculated using World Health Organization Anthro-Plus software/cutoffs to define normal weight, overweight and obesity among participants.

  2. Changes in Body fat (%)

    Time frame: 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).

  3. Changes in Skeletal Muscle Mass (kg)

    Time frame: 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).

Other outcomes

  1. Changes in Quality of Life using the PedsQL

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

    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.

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

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dorthe D Pauls, PhD

CONTACT

[email protected]

Jens M Bruun, Professor

CONTACT

[email protected]

+45 50945547

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study 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

Acronym: STOB

Important dates

Study start
2027
Primary completion
2028
Study completion
2036
First posted
Dec 24, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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