Condition category
Mental and Behavioural Disorders
Date applied
02/09/2015
Date assigned
05/10/2015
Last edited
05/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Attention deficit hyperactivity disorder (ADHD) is a group of behavioural symptoms that include poor concentration, hyperactivity and impulsiveness. A multimodal lifestyle intervention (Thin Bizzy) may help overweight children with ADHD to lose weight. The main aim of this study is to examine the effectiveness of this treatment in addition to treatment as usual.

Who can participate?
Overweight children with ADHD will be randomly selected among registered mental health care institutions, private psychology practices and paediatric practices across The Netherlands.

What does the study involve?
Children are randomly allocated to either receive the lifestyle intervention immediately (from week 0 to week 12) or to receive the treatment later (week 13 to week 24), both in addition to treatment as usual (medication or psychological treatment). Children receiving the lifestyle intervention will play sports three times a week and receive lifestyle training once a week under supervision of a Thin Bizzy coach. Assessments are carried out at the start of the study, during the intervention, after the intervention and at 3 months follow-up.

What are the possible benefits and risks of participating?
This study provides overweight children with ADHD the opportunity to join this lifestyle intervention to reduce BMI and ADHD symptoms, and improve their quality of life. Risks of participation in this study are limited as children receive training under supervision. Possible side effects are mild side effects that can be expected from exercising in the gym.

Where is the study run from?
This study has been set up by Yulius Academie (Netherlands).

When is the study starting and how long is it expected to run for?
January 2013 to December 2015.

Who is funding the study?
Not provided at time of registration.

Who is the main contact?
D. Smits, MSc
d.smits@yulius.nl

Trial website

Contact information

Type

Scientific

Primary contact

Dr Athanasios Maras

ORCID ID

Contact details

Dennenhout 1
Barendrecht
2994 GC
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Thin Bizzy: a multimodal lifestyle intervention for children with attention deficit hyperactivity disorder and overweight - a randomized controlled pilot study

Acronym

Study hypothesis

The effectiveness of a multimodal lifestyle intervention called 'Thin Bizzy' is assessed in this study. The main aim of the trial is to optimize daily functioning of children with attention deficit hyperactivity disorder (ADHD) and comorbid overweight by means of losing weight and enhancing their quality of life.

Does this multimodal lifestyle intervention reduce body mass index (BMI) and enhance quality of life in children with ADHD and comorbid overweight from 10 to 16 years of age? The expectation is that children will show a significant reduction in BMI after participating in this study compared to a control condition. Another expectation is that children will display less symptoms of ADHD and better self-efficiency and quality of life after participating in the intervention group.

Ethics approval

Medisch Ethische Toetsings Commissie TWOR, 03/07/2013, ref: MEC-2013_11, general reference number: NL44114.101.13

Study design

12-week immediate versus delayed intervention randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Attention deficit hyperactivity disorder (ADHD) and overweight/obesity

Intervention

The intervention in this study is a multimodal lifestyle intervention called Thin Bizzy consisting of lifestyle coaching and sports coaching. This treatment is offered as an additional intervention to treatment as usual.

Children are randomized to one of the following two groups:
1. An immediate treatment group (in which the treatment is available from week 0 to week 12).
2. A delayed treatment group (in which the treatment is available from week 13 to week 24)

In the first 12 weeks, children from the immediate treatment group will be asked to participate, continuing their treatment as usual. The results from this group will be compared to the other group following treatment as usual. After 12 weeks, the intervention will be available for the delayed treatment group. Several sports and lifestyle sessions are planned during the intervention under supervision of a Thin Bizzy coach. Several measures take place before, during and after the intervention. Children will be encouraged to continue this lifestyle after the intervention. They play sports three times a week and receive lifestyle training once a week (one hour both).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Body weight measured using Body Mass Index (BMI) at baseline, after 12 weeks (shortly after the intervention) and at 3 months follow-up (late after the intervention)

Secondary outcome measures

1. ADHD symptoms measured using the ADHD-vragenlijst (AVL)
2. Quality of life measured using the Impact of Weight on Quality of Life Questionnaire (IWQOL)
3. Self-efficiency measured using a self-constructed questionnaire

These outcome measures will be evaluated at baseline, during the intervention (week 5 and week 9), after 12 weeks (shortly after the intervention) and after 3 months follow-up by different questionnaires filled out by parents and the child. Socio-demographic information will be available through a parent-reported questionnaire at baseline.

Overall trial start date

01/01/2013

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. All children included in the study will be from 10 to 16 years of age
2. All children must have an official Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV ADHD diagnosis (all subtypes). The diagnosis must have been previously set by a child and adolescent psychiatrist, healthcare psychologist, clinical psychologist or paediatrician specialised in social paediatrics. Children with common diagnosed comorbid disorders (i.e., dyslexia, oppositional defiant disorder) can participate in the study
3. All children must have a comorbidity with overweight
4. All participants need to be stable on ADHD treatment, both pharmacological and psychological
4. Minimum total intelligence quotient (TIQ) score must greater than or equal to 80
5. Children can only be included after a written informed consent has been signed by both parents or legal guardians, indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Twelve year olds must give their own written informed assent in addition to their parents/legal guardians

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

22

Participant exclusion criteria

1. Children with a severe physical (i.e., developmental coordination disorder), neurological (i.e., epilepsy), or cognitive (i.e., mental handicap) disability will be excluded
2. Furthermore, children who are addicted to drugs, alcohol and/or gaming, have conduct disorder (CD) or have severe acute psychiatric disorders, psychotic disorder, major depressive disorder and mania will be excluded
3. Parents/legal guardians without a reasonable understanding of the Dutch language will be excluded

Recruitment start date

01/09/2013

Recruitment end date

01/06/2014

Locations

Countries of recruitment

Netherlands

Trial participating centre

Yulius Academie
Dennenhout 1
Barendrecht
2994 GC
Netherlands

Sponsor information

Organisation

Maasstad Hospital Rotterdam (Maasstadziekenhuis Rotterdam) (Netherlands)

Sponsor details

Toetsingscommissie Wetenschappelijk Onderzoek Rotterdam (TWOR)
Maasstadweg 21
Postbus 9100
Rotterdam
3007 AC
Netherlands

Sponsor type

Hospital/treatment centre

Website

www.maasstadziekenhuis.nl

Funders

Funder type

Other

Funder name

ADHD netwerk (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

De Gezonde Regio (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We hope to finish our article in December 2015.

Intention to publish date

01/12/2015

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes