Vyšetření na poruchu přejídání a poznatky o chování při přejídání u dětí a dospívajících účastnících se multicomponentního kempového programu s nebo bez intervence pro rodiče s poruchou přejídání (STOB)
Testování, ověřování a implementace screeningového nástroje (STOB) pro včasnou detekci poruchy příjmu potravy spojené s záchvatovitým přejídáním (BED) a poznatky o vývoji záchvatovitého přejídání u dětí a dospívajících účastnících se multicomponentní kempové intervence s nebo bez intervenčního programu pro rodiče s 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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Jens M Bruun, Professor
- Telefonní číslo: +45 50945547
- E-mail: jens.bruun@clin.au.dk
Studijní záloha kontaktů
- Jméno: Dorthe D Pauls, PhD
- E-mail: dorthedalstrup@clin.au.dk
Studijní místa
-
-
-
Hobro, Dánsko, 9500
- Julemærkehjemmet Hobro
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Kruså, Dánsko, 6340
- Julemærkehjemmet Fjordmark
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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. |
|
Experimentální: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Changes in Binge eating behavior using the STOB-screening tool
Časové okno: 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
Časové okno: Baseline
|
Binge eating disorder will be assessed using the Child Eating Disorder Examination interview |
Baseline
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Changes in Body Mass Index standard deviation score (BMI-SDS)
Časové okno: 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 (%)
Časové okno: 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.
|
|
Changes in Skeletal Muscle Mass (kg)
Časové okno: 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.
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Changes in Quality of Life using the PedsQL
Časové okno: 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.
|
|
Changes in appetitive traits using the CEBQ or AEBQ depending on age
Časové okno: 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
Časové okno: 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.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Jens M Bruun, Professor, University of Aarhus
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- STOB 2.0
- Journal number 05-0801-2595 (Jiné číslo grantu/financování: The Danish Health Authority)
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Plánujete sdílet data jednotlivých účastníků (IPD)?
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