Welcome
Support Centre
01 November 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Trial of ‘Families for Health’: helping families with children who are overweight to manage their weight
ISRCTN ISRCTN45032201
DOI 10.1186/ISRCTN45032201
ClinicalTrials.gov identifier
EudraCT number
Public title Trial of ‘Families for Health’: helping families with children who are overweight to manage their weight
Scientific title A randomised controlled trial evaluating the effectiveness and cost-effectiveness of ‘Families for Health’, a family-based childhood obesity treatment intervention delivered in a community setting for ages 7 to 11
Acronym N/A
Serial number at source HTA 09/127/41
Study hypothesis What is the effectiveness and cost-effectiveness of the 'Families for Health' (FFH) programme in the treatment of overweight and obesity in 7-11 year olds compared to usual care, as measured by reduction in BMI z-scores at one year post recruitment?

Our objectives are to:
1. Assess the effectiveness of the ‘Families for Health’ programme in reducing BMI z-score in children aged 7 to 11 who are overweight and obese
2. Evaluate the cost-effectiveness and cost-utility of the ‘Families for Health’ programme
3. Investigate parents’ and children’s views of the programme and their observations on approaches to maximising impact
4. To investigate facilitators’ views of the programme and their observations on approaches to maximising impact
Lay summary Background and study aims?
The prevalence of childhood obesity in the UK is high, and the NHS needs programmes which are effective in helping children who are already obese or overweight. A new programme called ‘Families for Health’ has been developed at the University of Warwick to help families reduce obesity in children aged 7 to 11. This is a group-based programme, 10 weeks long, involving children and their parents. In addition to a focus on healthy eating and activity, it is designed to help parents develop their parenting skills to support these lifestyle changes within the family. ‘Families for Health’ has been piloted in Coventry; children were less overweight after the programme, and the change was sustained up to 2 years. Improvements in children’s quality of life and lifestyle were also shown. This parenting approach was received very well by parents who found the programme helpful and supportive to bring about change in the family and with the management of their child with obesity.
The next stage of this research is to test how well this programme works in a larger study called a randomised controlled trial. The aims of the research are to find out if the ‘Families for Health’ programme manages to reduce overweight in children aged 7 to 11 and to estimate whether the programme is value for money. We are also interested in the children’s and parents’ views of the programme, its value to them and its impact on their lives.

What does the study involve?
The study will take place at three Primary Care Trusts in the West Midlands – NHS Coventry, NHS Warwickshire and Wolverhampton City PCT. In total, 120 families with at least one child aged 7-11 years who is overweight or obese will be recruited and then randomly allocated to either the ‘Families for Health’ intervention (60 families) or to a control group who receive ‘usual care’ (60 families). The results from the groups will be compared to examine how well ‘Families for Health’ works. The main measurement that we will use is the change in the children’s body mass index (BMI) (kg/m2). We will also carry out other measurements including children’s quality of life and physical activity, measures of the home eating and activity environment, parent-child relationships and parenting style. To assess if the programme is worth the money spent, the costs to the NHS to run the programme will be documented and costs then related to the changes in the children’s BMI z-score and quality of life.

Who can take part?
Families with at least one child aged 7-11 years who is overweight or very overweight.

When is the study starting and how long is it expected to run for?
The study will run from October 2011 to September 2014.

Where is the study run from?
The research measurements will be made at the homes of participating families. The ‘Families for Health’ intervention will be run in venues in the community (e.g. leisure centre, school).

What are the risks to participants?
A possible risk is the amount of time this study would take for parents and children. In particular, for families in the ‘Families for Health’ group, attendance at the group sessions is a weekly commitment for 10 weeks.

Who is funding the project?
National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme, and NHS Coventry, NHS Warwick and Wolverhampton City PCT.

Who is the main contact?
Dr Wendy Robertson
w.robertson@warwick.ac.uk
Ethics approval NRES Committe West Midlands - Coventry & Warwickshire, REC (Reference 11/WM/0290). Favourable ethical approval on 03/10/2011.

Substantial amendment approved on 23/01/2012.
Study design Multi-centre randomised controlled trial with economic analysis. Families will be randomised to:
1. ‘Families for Health’ (60 families)
2. Control group receiving ‘usual care’ (60 families)
Countries of recruitment United Kingdom
Disease/condition/study domain Childhood overweight and obesity
Participants - inclusion criteria 1. Families with at least one overweight (>91st centile for BMI) or obese (‘very overweight’) (>98th centile for BMI) child aged 7-11 years
2. At least one parent/guardian and child willing to take part
Participants - exclusion criteria 1. Parent or child with insufficient command of English, who would find it difficult to participate in the group
2. Metabolic or other recognised medical cause of obesity
3. Children with severe learning difficulties and/or behavioural problems
Anticipated start date 01/10/2011
Anticipated end date 30/09/2014
Status of trial Completed
Patient information material Not available in web format. Please use contact details below to request a patient information sheet
Target number of participants 120 families
Interventions Intervention arm:
‘Families for Health’ is a 10 week family-based intervention delivered in a community setting which is aimed at the treatment of children (7-11yrs) who are overweight or obese. The programme focuses on parenting combined with social and emotional development, as well as lifestyle change. Delivery is group-based with up to 10-12 families, with children and parents attending parallel groups and meeting mid-way for a healthy snack and activity. The programme is manualised, with detailed handbooks available to facilitators, parents and children.

‘Usual Care’ Control Group:
Families assigned to the ‘control’ arm will not be offered a specific intervention, but can receive the ‘usual care’ available in their area.
Primary outcome measure(s) 1. Change in children’s BMI z-score at 12 months follow-up (change from baseline)
2. (BMI (kg/m2) will be measured at baseline, 3 months and 12 months follow-up, and converted into standard deviation scores (z) from 1990 UK growth reference curves [Cole 1995])
Secondary outcome measure(s) Children’s measurements at baseline, 3 and 12 months:
1. Waist circumference (z-score)
2. Percentage body fat
3. Habitual activity (7-day accelerometer recording) (not at 3 months)
4. Quality of life (PedsQL) (Varni 1998)
5. Fruit and vegetable consumption (Edmunds 2002)

Parent’s measurements at baseline, 3 and 12 months:
1. BMI
2. Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) (Tennant 2007)
3. Family eating and activity (Golan 1998)
4. quality of parent-child relationships (Pianta 1992)
5. Parenting style (Robinson 2001)
6. Health state valuation (EQ-5D) (Dolan 1997)

Economic evaluation:
1. Incremental cost per quality-adjusted life year (QALY) gained, estimated using responses to the EuroQol EQ-5D-Y health state valuation (youth version) (Ravens-Sieberer et al, 2010), costs to deliver the programme and questionnaire of costs to attend completed by parents
2. A de novo decision-analytic model will also be developed in order to estimate the lifetime clinical and economic consequences of the ‘Families for Health’ intervention, using established economic modelling techniques

Process evaluation:
1. To investigate the parents’ and children’s perceptions of the ‘Families for Health’ programme in Coventry, Warwickshire and Wolverhampton. Interviews will be carried out with up to 24 intervention group parents and their children at the end of the intervention and at 12 months
2. To investigate the fidelity of the implementation and delivery of the ‘Families for Health’ programme in Coventry, Warwickshire and Wolverhampton. Programme fidelity will be assessed using flip-charts used during the sessions, parents’ weekly evaluation, facilitators’ weekly log of delivery, and audio recorded discussions with facilitators for four sessions in each programme
3. Success of recruitment methods, attendance rates (number of sessions attended) and drop out rates will be recorded
Sources of funding 1. NIHR - Health Technology Assessment Programme - HTA (UK): ref: 09/127/41
2. NHS Coventry
3. NHS Warwickshire
4. Wolverhampton City Primary Care Trust
Trial website
Publications 1. 2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23514100
Contact name Dr  Wendy  Robertson
  Address Associate Professor in Public Health
Division of Health Sciences
Warwick Medical School
University of Warwick
  City/town Coventry
  Zip/Postcode CV4 7AL
  Country United Kingdom
  Tel +44 (0)24 765 74660
  Email W.Robertson@warwick.ac.uk
Sponsor University of Warwick (UK)
  Address c/o Dr Peter Hedges (Sponsor Representative)
Director, Research Support Services
The University of Warwick
University House
Annex
Kirby Corner Road
  City/town Coventry
  Zip/Postcode CV4 8UW
  Country United Kingdom
  Tel +44 (0)24 7652 3859
  Email P.A.Hedges@warwick.ac.uk
  Sponsor website: http://www.warwick.ac.uk
Date applied 17/08/2011
Last edited 03/04/2013
Date ISRCTN assigned 18/08/2011
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.