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Lifestyle intervention for children with mental health disorders

Multidisciplinary approach of lifestyle intervention and physical examination of children with mental health disorders

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28236
Enrollment
80
Registered
2021-11-01
Start date
2022-01-16
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children with psychiatric disorders (e.g. ADHD, Autism, Anxiety disorders, Depression) and an unhealthy lifestyle.

Interventions

Lifestyle intervention group The intervention combines an awareness consult, psycho-education on healthy lifestyle, and optimization of pharmacotherapy (i.e., CAU) together with a lifestyle program th

Sponsors

ZonMw
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - between 6-12 years old; - a diagnosis according to the DSM-5 (any presentation); - somatic concern assessed by medical examination and/or lifestyle screening (overweight, obesity, underweight, unhealthy diet, sleeping problems, inactivity and screen time use); - willingness to set lifestyle goals; Comorbidities are allowed except for severe eating disorders (i.e. anorexia) and diabetes mellitus type I.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - unable to respond to questions (parents or children); - no access to a home internet connection; - insufficient mastery of Dutch language in parents or children; - physically incapable to do physical exercises; - surgery in past 6 months or next 12 months impacting physical activity or dietary intake; - any, medical condition severely restricting diet. - severe underweight

Design outcomes

Primary

MeasureTime frame
Primary Objective: The primary objective of this study is to test the effectiveness of a multi-modal lifestyle intervention program in routine clinical care compared to care as usual (CAU) for children (6-12 years) with mental health problems in increasing their Quality of Life (QoL) using the KIDSCREEN-27 Questionnaire.

Secondary

MeasureTime frame
Secondary Objectives: Additional objectives are (1) to investigate the effectiveness of the program compared to CAU on mental health, (2) to investigate the effectiveness of the program compared to CAU on physical health and lifestyle parameters, (3) to identify potential moderators and mediators of the response to the lifestyle program and (4) to assess cost-effectiveness the lifestyle program for these specific children.

Contacts

Public ContactEmilie van Tetering

Karakter Kinder- en Jeugdpsychiatrie en Radboud UMC

e.vantetering@karakter.com0650005544

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)