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Набор скоро начнётся NCT07301541

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

Без фазы С лечением Binge Eating Disorder Binge Eating Loss of Control Eating Overweight , Obesity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: A 10-week multicomponent camp intervention for children, A BED intervention for parents.
Кому может быть актуально
Состояния в реестре: Binge Eating Disorder, Binge Eating, Loss of Control Eating, Overweight , Obesity. Базовые параметры: 7 лет — 14 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Дания
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое A 10-week multicomponent camp intervention for children
    A 10-week multicomponent camp intervention for participating children only, focusing on social and physical activities, healthy meals, and daily physical activities.
  • Поведенческое A BED intervention for parents
    An add-on virtual parent-based intervention providing knowledge about BED and tools to support their child's eating after the multicomponent camp intervention.

Первичные конечные точки

  • Changes in Binge eating behavior using the STOB-screening tool [Срок оценки: 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 [Срок оценки: Baseline, and 10-weeks (post-intervention).]
Вторичные конечные точки (3)
  • Changes in Body Mass Index standard deviation score (BMI-SDS) [Срок оценки: Baseline, 10-weeks (post-intervention), 10-12 weeks after the intervention, and 1, 3 and 5 years after the intervention.]
  • Changes in Body fat (%) [Срок оценки: Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.]
  • Changes in Skeletal Muscle Mass (kg) [Срок оценки: Baseline, 10-weeks (post-intervention), and 1, 3 and 5 years after the intervention.]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Дания · 2 центра
  • Julemærkehjemmet Hobro — Hobro
  • Julemærkehjemmet Fjordmark — Kruså

Идентификаторы

NCT: NCT07301541 · STOB 2.0 · Journal number 05-0801-2595

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗