Plain English 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 childrens 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 childrens and parents views of the programme, its value to them and its impact on their lives.
Who can participate?
Families with at least one child aged 7-11 years who is overweight or very overweight.
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. Families will be 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 childrens body mass index (BMI) (kg/m2). We will also carry out other measurements including childrens 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 childrens BMI z-score and quality of life.
What are the possible benefits and risks of participating?
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.
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).
When is the study starting and how long is it expected to run for?
October 2011 to September 2014
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Wendy Robertson
ORCID ID
Contact details
Associate Professor in Public Health
Division of Health Sciences
Warwick Medical School
University of Warwick
Coventry
CV4 7AL
United Kingdom
+44 (0)24 765 74660
W.Robertson@warwick.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 09/127/41
Study information
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
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?
The 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 childrens 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
Ethics approval
1. NRES Committee West Midlands - Coventry & Warwickshire, 03/10/2011, ref: 11/WM/0290
2. Substantial amendment approved 23/01/2012
Study design
Multi-centre randomised controlled trial with economic analysis
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format. Please use contact details to request a patient information sheet
Condition
Childhood overweight and obesity
Intervention
Families will be randomised to:
1. Families for Health (60 families)
2. Control group receiving usual care (60 families)
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.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Change in children's BMI z-score at 12 months follow-up (change from baseline) (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 measures
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)
Parents' 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 childrens 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
Overall trial start date
01/10/2011
Overall trial end date
30/09/2014
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
120 families
Participant 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
Recruitment start date
01/10/2011
Recruitment end date
30/09/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Warwick
Coventry
CV4 7AL
United Kingdom
Sponsor information
Organisation
University of Warwick (UK)
Sponsor details
c/o Dr Peter Hedges (Sponsor Representative)
Director
Research Support Services
The University of Warwick
University House
Annex
Kirby Corner Road
Coventry
CV4 8UW
United Kingdom
+44 (0)24 7652 3859
P.A.Hedges@warwick.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Funder name
NHS Coventry
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS Warwickshire
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Wolverhampton City Primary Care Trust
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
Basic results (scientific)
Publication list
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23514100
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26607762
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28059054
Publication citations
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Protocol
Robertson W, Stewart-Brown S, Stallard N, Petrou S, Griffiths F, Thorogood M, Simkiss D, Lang R, Reddington K, Poole F, Rye G, Khan KA, Hamborg T, Kirby J, Evaluation of the effectiveness and cost-effectiveness of Families for Health V2 for the treatment of childhood obesity: study protocol for a randomized controlled trial., Trials, 2013, 14, 81, doi: 10.1186/1745-6215-14-81.