Screening for Spiseanfallslidelse og innsikt i spiseanfallsatferd hos barn og ungdom som deltar i en flerkomponent leirintervensjon med eller uten foreldreintervensjon for spiseanfallslidelse (STOB)
Test, validering og implementering av et screeningsverktøy (STOB) for tidlig oppdagelse av spiseanfallslidelse (BED) og innsikt i utviklingen av spiseanfall hos barn og ungdom som deltar i en flerkomponent leirkur med eller uten foreldreintervensjon for 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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Jens M Bruun, Professor
- Telefonnummer: +45 50945547
- E-post: jens.bruun@clin.au.dk
Studer Kontakt Backup
- Navn: Dorthe D Pauls, PhD
- E-post: dorthedalstrup@clin.au.dk
Studiesteder
-
-
-
Hobro, Danmark, 9500
- Julemærkehjemmet Hobro
-
Kruså, Danmark, 6340
- Julemærkehjemmet Fjordmark
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: 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. |
|
Eksperimentell: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in Binge eating behavior using the STOB-screening tool
Tidsramme: 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
Tidsramme: Baseline
|
Binge eating disorder will be assessed using the Child Eating Disorder Examination interview |
Baseline
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in Body Mass Index standard deviation score (BMI-SDS)
Tidsramme: 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 (%)
Tidsramme: 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)
Tidsramme: 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.
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in Quality of Life using the PedsQL
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Jens M Bruun, Professor, University of Aarhus
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Psykiske lidelser
- Ernæringsforstyrrelser
- Overernæring
- Kroppsvekt
- Hyperfagi
- Tegn og symptomer, fordøyelseskanal
- Fôring og spiseforstyrrelser
- Patologiske tilstander, tegn og symptomer
- Ernæringsmessige og metabolske sykdommer
- Tegn og symptomer
- Overvektig
- Bulimi
- Overvekt
- Pediatrisk fedme
- Overstadig spiseforstyrrelse
Andre studie-ID-numre
- STOB 2.0
- Journal number 05-0801-2595 (Annet stipend/finansieringsnummer: The Danish Health Authority)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .