Determining the short-term and long-term (12 months) effectiveness and cost-effectiveness of a lifestyl intervention treatment as the first addition to care as usual (CAU) in comparison to providing CAU only, in children with psychiatric disorders (…
ID
Source
Brief title
Condition
- Other condition
- Psychiatric disorders NEC
Synonym
Health condition
Kwaliteit van Leven, Leefstijl
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quality of life.
Secondary outcome
Emotional and behavior problems
Cognitive assessment (COTAPP and IQ)
Physical, somatic and biological measurements
Lifestyle parameter - sleep, diet, physical acitvity, screen time.
Measurement of costs.
Parenting styles and family functioning.
Prior beliefs/satisfaction/adherence.
Background summary
Unhealthy lifestyle is frequently seen among children in the Netherlands. Most
common forms of unhealthy lifestyle in this population include the consumption
of diet rich in saturated fats and sugar, inactivity, excessive gaming and
distorted sleep patterns. Unfortunately, unhealthy lifestyle and poor physical
health are even more frequently seen among children with mental health illness
such as autism, ADHD, depression and anxiety disorder. However, research on
lifestyle interventions among children with mental health illness is lacking.
As a result, there are currently no guidelines, treatment programs or equipped
treatment centers where children with mental health problems and poor lifestyle
quality can receive proper treatment. The aim of this study is to develop and
implement a multi-modal lifestyle intervention program in routine clinical care
for children with mental health disorders.
Study objective
Determining the short-term and long-term (12 months) effectiveness and
cost-effectiveness of a lifestyl intervention treatment as the first addition
to care as usual (CAU) in comparison to providing CAU only, in children with
psychiatric disorders (6-14 years).
Hypotheses: Offering a lifestyle intervention ensures that not only physical
health, but also mental health improves.
Study design
RCT with an intervention group and a control group perfomed in one psychiatric
centre in the Netherlands.
Intervention
In the lifestyle intervention condition, patients will start with an awareness
consult and psycho-education on a healthy lifestyle. The 12-week intervention
involves family-based education on healthy lifestyle in combination with the
following elements depending on which lifestyle factors need to be improved or
a combination of treatment: (1) optimization of sleep based behavioural therapy
by a sleep expert, (2) physical activation/sport activity supervised by an
psychomotor therapist, (3) dietary treatment provided by a dietician following
national guidelines for a healthy diet according to age and sex, and/or (4)
restoration of a balanced use of *screen time* according to age specific
guidelines. To generalize healthy behaviour in the family a home coach will be
involved to visit the families at their homes, schools and sport clubs of the
child to give education on healthy lifestyle.
Standard intervention to be compared to:
- CAU consisting of an awareness consult and psycho-education focused on
lifestyle followed by the regular care (medication and / or psychosocial
intervention).
Study burden and risks
Burden on the participants in the lifestyle intervention is mainly related to
the different measurement moments (four times during a period of one year).
Burden consists of a venipuncture (15 ml, twice). This can be experienced as
annoying.
Burden for all participants are non-invasive measurements. For children (IQ,
Cogntive assessment (COTAPP), physical fitness test, wearing an actigraph) the
time duration per assessment varies between 1,5 and 2 hours (four assessments
in total in 1 year) . For parents (questionnaires) the time duration of the
begin/end point assessment (T0, T1, T4) is around 30 and 60 minutes. We believe
this is feasible.
Benefits for the participants are good monitoring of treatment effectiveness
and the possibility to receive treatment on lifestyle, while this is not (yet)
covered by the health insurance.
Parents receive 20 euros per assessment for compensation of travel expenses and
time investment; children receive a small gift (worth 3 euros).
Reinier Postlaan 12
Nijmegen 6525 GC
NL
Reinier Postlaan 12
Nijmegen 6525 GC
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- between 6-13 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 and II.
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;
- unwillingness to have meat or animal food products in the diet (without these
products it is impossible to achieve nutritional adequacy of the overall);
- 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL77440.091.21 |