Dépistage du trouble de l'hyperphagie boulimique et aperçus du comportement d'hyperphagie boulimique chez les enfants et adolescents participant à une intervention multicomposante en camp avec ou sans intervention parentale pour le THB (STOB)
Test, Validation et Mise en Œuvre d'un Outil de Dépistage (STOB) pour la Détection Précoce du Trouble de l'Alimentation Compulsive (BED) et Éclairages sur le Développement de la BE chez les Enfants et Adolescents Participant à une Intervention de Camp Multicomposant Avec ou Sans Intervention Parentale pour le BED
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Jens M Bruun, Professor
- Numéro de téléphone: +45 50945547
- E-mail: jens.bruun@clin.au.dk
Sauvegarde des contacts de l'étude
- Nom: Dorthe D Pauls, PhD
- E-mail: dorthedalstrup@clin.au.dk
Lieux d'étude
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Hobro, Danemark, 9500
- Julemærkehjemmet Hobro
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Kruså, Danemark, 6340
- Julemærkehjemmet Fjordmark
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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. |
A 10-week multicomponent camp intervention for participating children only, focusing on social and physical activities, healthy meals, and daily physical activities. |
|
Expérimental: 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. |
A 10-week multicomponent camp intervention for participating children only, focusing on social and physical activities, healthy meals, and daily physical activities. An add-on virtual parent-based intervention providing knowledge about BED and tools to support their child's eating after the multicomponent camp intervention. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Changes in Binge eating behavior using the STOB-screening tool
Délai: 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. A 'yes' response to either overeating or loss-of-control eating is considered a positive screening result. |
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
Délai: Baseline
|
Binge eating disorder will be assessed using the Child Eating Disorder Examination interview |
Baseline
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Changes in Body Mass Index standard deviation score (BMI-SDS)
Délai: Baseline, 10-weeks (post-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. 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 |
Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.
|
|
Changes in Body fat (%)
Délai: 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). |
Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.
|
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Changes in Skeletal Muscle Mass (kg)
Délai: 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). |
Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Changes in Quality of Life using the PedsQL
Délai: Baseline, 10-weeks (post-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. Responses are scored on a 0-100 scale with higher scores indicating higher QoL. |
Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.
|
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Changes in appetitive traits using the CEBQ or AEBQ depending on age
Délai: Baseline, 10-weeks (post-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. Responses are scored on a 1-5 scale, with higher scores indicating a greater tendency toward the behavior. |
Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.
|
|
Change in eating disorder symptoms using EDE-QS
Délai: Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.
|
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. |
Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jens M Bruun, Professor, University of Aarhus
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Les troubles mentaux
- Troubles nutritionnels
- Suralimentation
- Poids
- Hyperphagie
- Signes et symptômes digestifs
- Troubles de l'alimentation et de l'alimentation
- Conditions pathologiques, signes et symptômes
- Maladies nutritionnelles et métaboliques
- Signes et symptômes
- En surpoids
- Boulimie
- Obésité
- Obésité pédiatrique
- Trouble de l'hyperphagie boulimique
Autres numéros d'identification d'étude
- STOB 2.0
- Journal number 05-0801-2595 (Autre subvention/numéro de financement: The Danish Health Authority)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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