Condition category
Nutritional, Metabolic, Endocrine
Date applied
17/08/2011
Date assigned
18/08/2011
Last edited
27/11/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 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

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?

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

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)

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 below to request a patient information sheet

Condition

Childhood overweight and obesity

Intervention

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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 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)

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

Overall trial start date

01/10/2011

Overall trial end date

30/09/2014

Reason abandoned

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

Associate Professor in Public Health
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

http://www.warwick.ac.uk

Funders

Funder type

Government

Funder name

NIHR - Health Technology Assessment Programme - HTA (UK): ref: 09/127/41

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23514100
2015 protocol in http://www.ncbi.nlm.nih.gov/pubmed/26607762

Publication citations

  1. 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.

Additional files

Editorial Notes

27/11/2015: Publication reference added.