Trial of ‘Families for Health’: helping families with children who are overweight to manage their weight

ISRCTN ISRCTN45032201
DOI https://doi.org/10.1186/ISRCTN45032201
Protocol serial number HTA 09/127/41
Sponsor University of Warwick (UK)
Funders Health Technology Assessment Programme, NHS Coventry, NHS Warwickshire, Wolverhampton City Primary Care Trust
Submission date
17/08/2011
Registration date
18/08/2011
Last edited
09/01/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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.

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 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.

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

Contact information

Dr Wendy Robertson
Scientific

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

Study information

Primary study designInterventional
Study designMulti-centre randomised controlled trial with economic analysis
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleA 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
Study objectivesWhat 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 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
Ethics approval(s)1. NRES Committee West Midlands - Coventry & Warwickshire, 03/10/2011, ref: 11/WM/0290
2. Substantial amendment approved 23/01/2012
Health condition(s) or problem(s) studiedChildhood overweight and obesity
InterventionFamilies 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 typeBehavioural
Primary outcome measure(s)

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])

Key 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

Completion date30/09/2014

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit7 Years
Upper age limit11 Years
SexAll
Target sample size at registration120
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/10/2011
Date of final enrolment30/09/2014

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

University of Warwick
Coventry
CV4 7AL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 25/11/2015 Yes No
Results article results 01/01/2017 Yes No
Protocol article protocol 20/03/2013 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

09/01/2017: Publication reference added.
27/11/2015: Publication reference added.

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