Treating childhood obesity: a randomised, controlled trial of a family-based behavioural treatment

ISRCTN	ISRCTN51382628
DOI	https://doi.org/10.1186/ISRCTN51382628
Protocol serial number	N/A
Sponsor	Cancer Research UK Health Behaviour Unit
Funder	Cancer Research UK (CRUK) (UK) - Health Behaviour Unit

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Jane Wardle
Scientific

Health Behaviour Unit
University College London
2-16 Torrington Place
London
WC1E 6BT
United Kingdom

Email	j.wardle@ucl.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	1. There will be a significant difference in body mass index (BMI) pre- to post-intervention within the treatment group 2. There will be a significant improvement in participants eating behaviours pre- to post-intervention within the treatment group 3. There will be a significant improvement in the physical health profile of participants pre- to post-intervention within the treatment group 4. There will be a significant improvement in the psychological well-being of children pre- to post-intervention within the treatment group
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Overweight/obesity
Intervention	Family-based behavioural treatment versus waiting list control
Intervention type	Other
Primary outcome measure(s)	1. Weight 2. Body mass index (BMI) 3. Percentage BMI
Key secondary outcome measure(s)	1. Other child anthropometric measures (waist, body composition) 2. Child blood lipids/glucose/insulin/blood pressure 3. Eating behaviours, dietary intake, activity level (using accelerometers), self-esteem, mood 4. Parental eating behaiours and parenting style
Completion date	01/01/2007

Participant type(s)	Patient
Age group	Child
Lower age limit	8 Years
Upper age limit	12 Years
Sex	All
Target sample size at registration	72
Key inclusion criteria	Participants will be children aged 8-12 years who are overweight or obese as defined using the International Obesity Taskforce BMI definition. Eligible subjects will be those with simple obesity/overweight who have had other treatable causes of obesity excluded. At least one parent must be willing to participate in treatment.
Key exclusion criteria	1. Significant learning difficulties in child or parent 2. Significant mental health problems in child or parent 3. Insufficient command of English to participate in the groups
Date of first enrolment	01/01/2004
Date of final enrolment	01/01/2007

Health Behaviour Unit

London
WC1E 6BT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2012		Yes	No