Набор скоро начнётся NCT07158944

Effectiveness of a Family Support Model for Prevention and Management of Overweight and Obesity in Children 6-12 Years

Без фазы С лечением Obesity &Amp; Overweight

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: More and Less.
Кому может быть актуально: Состояния в реестре: Obesity &Amp; Overweight. Базовые параметры: 6 лет — 12 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: Швеция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Coherent Family Support Model (Co-Fam) for Prevention and Management of Childhood Obesity: Protocol for a Hybrid Type 2 Effectiveness-implementation Trial

Обзор

The study will evaluate a coherent model of family support including school health care, primary health care and pediatric clinics. The model combines two evidence based programs: the universal "A Healthy School Start" provided to all children and their families during grade 1 and the targeted parental support program "More and Less" provided to parents of children with overweight or obesity. The hypothesis is that combining the Healthy School Start and More and Less programs in a coherent model will increase the collaboration between regional and municipal stakeholders, ensure early identification of families in need, ultimately improving prevention and treatment of childhood overweight and obesity. The aim of this study is to evaluate the implementation of a coherent model of family support provided through school and primary health care.

Подробное описание

In this hybrid type 2 effectiveness-implementation study, a two-armed randomized controlled trial will randomize families to either the intervention arm receiving the More and Less program or the control arm receiving standard care from primary health care or a pediatric clinic. A matched control group will be identified from a national obesity register for supplementary comparison. Eligible participants are families with children aged 6-12 years with overweight or obesity, enrolled in schools implementing the Healthy School Start program. Effectiveness outcomes to evaluate the intervention are BMI z-score, parental feeding practices, diet and physical activity, child eating behaviour and intervention fidelity which will be measured at baseline, three and 12 months. Implementation outcomes will be evaluated in a process evaluation assessing reach, fidelity, acceptability, feasibility and cost, assessed at 12 and 24 months using a mixed methods approach.

Вмешательства

Поведенческое More and Less
Dose: 10 group sessions + 6 individual booster sessions Frequency: 10 weekly group sessions (10 weeks) 6 booster sessions every 6th week

Первичные конечные точки

BMI z-score [Срок оценки: Measured at baseline, 3 and 12 months.]

Вторичные конечные точки (4)

The child's dietary habits [Срок оценки: Measured at baseline, 3 and 12 months follow-up]
The child's physical activity level [Срок оценки: Measured at baseline, 3 and 12 months]
The child's eating behavior [Срок оценки: Measured at baseline, 3 and 12 months]
Parental feeding practices [Срок оценки: Measured at baseline, 3 and 12 months]

Критерии участия

Критерии включения

A parent of a child between 6-12 years of age.
The child attends a school providing the Healthy School Start program.
The child has been diagnosed with overweight (age standardized BMI of 25 or above) or obesity (age standardized BMI of 30 or above) by a health care personnel.