Contact information
Type
Scientific
Primary contact
Prof Jane Wardle
ORCID ID
Contact details
Health Behaviour Unit
University College London
2-16 Torrington Place
London
WC1E 6BT
United Kingdom
j.wardle@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Overweight/obesity
Intervention
Family-based behavioural treatment versus waiting list control
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Weight
2. Body mass index (BMI)
3. Percentage BMI
Secondary outcome measures
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
Overall trial start date
01/01/2004
Overall trial end date
01/01/2007
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
72
Participant 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
Recruitment start date
01/01/2004
Recruitment end date
01/01/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Health Behaviour Unit
London
WC1E 6BT
United Kingdom
Sponsor information
Organisation
Cancer Research UK Health Behaviour Unit
Sponsor details
University College London
2-16 Torrington Place
London
WC1E 6BT
United Kingdom
k.swingewood@ucl.ac.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK) - Health Behaviour Unit
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21931327
Publication citations
-
Results
Croker H, Viner RM, Nicholls D, Haroun D, Chadwick P, Edwards C, Wells JC, Wardle J, Family-based behavioural treatment of childhood obesity in a UK National Health Service setting: randomized controlled trial., Int J Obes (Lond), 2012, 36, 1, 16-26, doi: 10.1038/ijo.2011.182.