ifestyle intervention for children with mental health disorders
- Conditions
- Children with psychiatric disorders (e.g. ADHD, Autism, Anxiety disorders, Depression) and an unhealthy lifestyle.
- Registration Number
- NL-OMON28236
- Lead Sponsor
- ZonMw
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 80
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Objective:<br>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. <br>
- Secondary Outcome Measures
Name Time Method Secondary Objectives: <br>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.<br>