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Thin Bizzy: a multimodal lifestyle intervention for children with attention deficit hyperactivity disorder and overweight

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10990143
Enrollment
22
Registered
2015-10-05
Start date
2013-09-01
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Attention deficit hyperactivity disorder (ADHD) and overweight/obesity Mental and Behavioural Disorders

Interventions

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

Sponsors

Maasstad Hospital Rotterdam (Maasstadziekenhuis Rotterdam) (Netherlands)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026