Condition category
Nutritional, Metabolic, Endocrine
Date applied
09/09/2005
Date assigned
02/11/2005
Last edited
20/12/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

Additional files

Editorial Notes