PARTICIPANT INFORMATION SHEET
Randomised Controlled Trial of ‘Families for Health’:
a family-based intervention for children who are overweight
Version 3 (Parents) - Dated 3/8/12 (Warwickshire)
We would like to invite you to take part in our research study. Before you decide we
would like you to understand why the research is being done and what it would
involve for you and your family. Please take time to read the following information.
Talk to others about the study if you wish. One of our team will go through the
information sheet with you and answer any questions you have.
Part 1 tells you the purpose of the study and what will happen if you take part.
Part 2 gives you more detailed information about the conduct of the study.
Please ask us if there is anything that is not clear or if you would like more
information.
Wendy Robertson
Tel: 024 7657 4660
Email: W.Robertson@warwick.ac.uk
1
Part 1 of the Information Sheet
1.
What is the purpose of the study?
Being overweight is becoming more common in children in the UK and can lead to
health problems, low self-esteem, and being overweight as an adult. In adulthood,
being overweight increases the risk of heart disease, diabetes and other illnesses.
We want to find ways to help children who are overweight. Research from around
the world shows that programmes which closely involve parents are the most likely
to be helpful.
Parents have the potential to play a key role in managing the weight of their children
by changing the environment in which they live (e.g. what is eaten at home) and by
providing more opportunities for exercise. Our skills as parents may be key to this
change. With this focus, the ‘Families for Health’ programme has been developed at
the University of Warwick. This family centred programme has undergone piloting
but it is now important to assess whether it is effective in a more rigorous study
design, known as a Randomised Controlled Trial. We are comparing the ‘Families
for Health’ programme’ to ‘usual care’. The study will last for 12 months.
2.
What is the ‘Families for Health’ programme ?
‘Families for Health’ is a new group-based programme for 6 to 11 year old children
who are overweight and their parents/carers. The programme consists of group
sessions lasting 2½ hours involving 10-12 parents and their child(ren) every week for
10 weeks. We will also be holding follow-up sessions one and three months after the
end of the programme.
Parents and children will attend separate groups, with a shared activity during the
course of the sessions. The group sessions will be run by people who are specially
trained, all of whom will have been ‘police checked’ for their suitability to work with
children. The parents’ sessions will focus on helping parents develop solutions to
problems, parenting skills, healthy eating and keeping the family active. The
sessions for the children will include fun activities on healthy eating, opportunities to
engage in physical activities and support with their emotional needs.
3. What is ‘usual care’ in Warwickshire’?
NHS Warwickshire offers one-to-one advice from a Change4Life Advisor. This
would involve you and your child being offered support from your local Change4Life
Advisor who would tailor their advice to you and your family’s specific needs. This
will take place in your home and at a time convenient to you.
4.
Why have I been invited?
We are aiming to recruit 120 families in total to the study, from across Coventry,
Warwickshire and Wolverhampton.
You and your child have been invited to participate because your family doctor,
school nurse, paediatrician, or other health worker has identified that your child is
2
aged between 6 to 11 years and is overweight or very overweight for his/her age and
height. Measurements of height and weight may have been made at school. The
assessment of ‘overweight’ has been made using standard charts.
Alternatively, you may have responded to an article in the local paper about the
research, or to a story on the radio, because you and your child are interested in
taking part.
5.
Do we have to take part?
It is up to you and your child to decide to join the study. We will describe the study
and go through this information sheet. If you agree to take part, we will then ask you
to sign a consent form. You are free to withdraw at any time, without giving a reason.
This would not affect the standard of care you receive.
6.
What will happen if we take part in the study?
The study is a Randomised Controlled Trial. Sometimes we don’t know which way of
treating patients is best. To find out, we need to compare different treatments.
In this study families will be allocated by chance to one of two groups, either to
receive the ‘Families for Health’ programme or to be offered the usual treatments
(‘usual care’) available in Warwickshire. The groups are selected by a computer, and
each family has a 50:50 chance of getting either the ‘Families for Health’ programme
or ‘usual care’.
All families will have measurements taken in their own home at the start of the study,
at 3 months and finally at 12 months. Measurements taken will be compared
between the two groups to find out if the programme works. The measurements that
we wish to make are:Measurements with your Child


Height, weight, waist size and physical activity.
Questionnaires about daily activities and quality of life.
Measurements with Parents/Carers


Height and weight.
Questionnaires about family eating habits, relationship with your child, your style
of parenting, quality of life of your child and your own sense of well being.

Parents will be asked to complete a questionnaire about their experiences of the
‘Families for Health’ programme, at the end of the intervention.
Interviews

Up to 48 parents and their children will be interviewed to obtain their experiences
of either the Families for Health programme (up to 24 families) or the usual
treatment (up to 24 families), and its impact on them. The interviews will be taperecorded if parent’s consent is given.
3

At 12-month follow-up, the parents and their children will be interviewed again to
assess if any changes have been sustained.
If your family was allocated to the ‘Families for Health’ programme this would involve
you the parent/carer and your child attending the 2½ hour session each week for 10
weeks at a community venue in Warwickshire (e.g. school, youth club, leisure
centre). If your family was allocated to ‘usual care’ you would be given details of the
options in Warwickshire and encouraged to attend.
The programme will be running in 2012, most likely on a Saturday. There will also
be two follow-up sessions, at 1-month and 3-months after the intervention has
ended. Participation in the research will be for 12 months.
7.
Payments
As a ‘thank-you’ for participation in the research, each family will be given £15 at
each of the three measurement points.
8.
What will we have to do?
If you were allocated to the ‘Families for Health’ group, you and your child would
have to try to attend all of the sessions of the programme. During the group sessions
you would be given a handbook. There would be suggestions for activities for you
and your child to try between the sessions.
If you were allocated to the ‘usual care’ group, we would want your family to continue
life as normal and consider participation in the usual care available in Warwickshire.
9.
What are the possible disadvantages and risks of taking part?
A possible disadvantage is the amount of time this study would take for you and your
child. In particular, if you were in the ‘Families for Health’ group, attendance at the
group sessions is a weekly commitment for 10 weeks.
10.
What are the possible benefits of taking part?
The ‘Families for Health’ programme has been designed to help you with your child’s
weight management, with parenting skills and with your relationship with your child.
Likewise, ‘usual care’ in Warwickshire may help you and your family with lifestyle
and weight management issues.
We cannot promise the study will help you but the information we get from this study
will help families with children who are overweight in the future.
4
11.
What happens when the research study stops?
In each Primary Care Trust the research study is being run within the context of a
care pathway to provide support for families with children who are overweight.
Further support will be identified for families, as appropriate, when the research
study stops.
After the end of the research, both children and parents in the ‘Families for Health’
group will keep their copies of the programme handbook to refer to if they so wish.
12.
What if there is a problem?
Any complaint about the way you have been approached or treated during the study
or any possible harm you might suffer will be addressed. The detailed information on
this is given in Part 2.
13.
Will my taking part in the study be kept confidential?
Yes. We will follow ethical and legal practice and all information about you and your
child will be handled in confidence. The details are included in Part 2.
This completes Part 1. If this information has interested you and you are considering
participation, please read the additional information in Part 2 before making any
decision.
5
Part 2 of the Information Sheet
1.
What if relevant new information becomes available?
If we get new information about the treatment being studied or if the research study
has to be stopped, we will tell you and discuss the care for your family.
2.
What will happen if I don’t want to carry on with the study?
You are free to withdraw from the study at any time, without giving a reason.
If you are in the ‘Families for Health’ group you can withdraw from the intervention.
However, you may be willing for us to keep in contact with you to let us know your
progress, and to have research measurements made. Families will still be given the
£15 at each measurement point if they decide to continue with the measurements.
We will need to retain the data that we have already collected on your family.
3.
What if there is a problem?
If you have a concern about any aspect of the study you should ask to speak to the
researchers or NHS staff who will do their best to answer your questions. Please
contact:
University of Warwick
Wendy Robertson
Associate Professor
Warwick Medical School
University of Warwick
Coventry
CV4 7AL
NHS Warwickshire
Fran Poole
Health Development Manager
Public Health Department
NHS Warwickshire
Westgate House
Market Street
Warwick
CV34 4DE
Tel: 024 7657 4660
Email: w.robertson@warwick.ac.uk
Tel 01926 493 491 ext 277
Email: francine.poole@nhs.net
If you remain unhappy and wish to complain formally, complaints should be
addressed to the University of Warwick using the following contact details:
University of Warwick - complaints
Nicola Owen
Deputy Registrar
Deputy Registrar's Office
University of Warwick
Coventry
CV4 8UW
Tel: 024 7652 2785
E: Nicola.Owen@warwick.ac.uk
6
The University of Warwick is acting as Sponsor for this study. This means that the
University has overall responsibility for the safety, management, conduct, financial
and legal aspects of the research being undertaken. As part of this responsibility, the
University has in force a Public and Products Liability policy which provides cover for
claims for “negligent harm” and the activities here are included within that coverage
subject to the terms, conditions and exceptions of the policy.
4.
Will my taking part in this study be kept confidential?
All information which is collected about you and your child during the course of the
research would be kept strictly confidential.
Paper copies of personal data will be stored in a locked filing cabinet, with access
only to the members of the research team who require the use of this data. Any
information about you and your child will have your name and address removed so
that you cannot be recognised from it.
Data will be inputted into a clinical trial database held on a secure server at the
University of Warwick. The server is located in a purpose built data centre protected
by CCTV surveillance. Access to the database is controlled using passwords, and
only the research staff required to view the data are given access.
The only reason that confidentiality would need to be broken is if there is cause for
concern that your child is at risk in someway. If this is the case you will be informed
before any action is taken.
The funder of the research (NHS NIHR Health Technology Assessment programme)
may wish to check that the study is being carried out correctly. Access to paper and
electronic files would be given to authorised people, which would be set up on a
limited basis for the duration of their visit. All will have a duty of confidentiality to you
as a research participant.
5. Involvement of the General Practitioner / Family Doctor (GP)
With your agreement, we would notify your child’s General Practitioner and if
appropriate your child’s Paediatrician of their participation in the study.
6.
What will happen to the results of the research study?
(a) Broad Scientific Results of the Trial
The results will be used to decide whether the ‘Families for Health’ programme can
help families who have a child who is overweight. The results of the study will be
written up in reports for the funder, the Primary Care Trusts and health care journals.
The identity of those taking part will not be identified in any report or publication.
We will send you a summary of the results in the post.
(b) Results with Relevance to the Individual
The results of your child’s weight and height will be made available to you.
7
7.
Who is organising and funding the research?
The research is being organised by Dr Wendy Robertson from the Medical School at
the University of Warwick, in conjunction with a team of researchers and
collaborators from the NHS in the Coventry, Warwickshire and Wolverhampton.
The research is funded by the NHS’s National Institute for Health Research Health
Technology Assessment programme. The researchers do not receive any additional
payment for including you in the study.
8.
Who has reviewed the study?
All research in the NHS is looked at by an independent group of people, called a
Research Ethics Committee, to protect your interests. The study has been reviewed
and given a favourable opinion by Coventry and Warwickshire Research Ethics
Committee.
A Trial Steering Committee has also been set up to oversee the research. This
committee has two independent members (i.e. outside the research team), one
parent with experience of the ‘Families for Health’ intervention, and investigators.
9. Further information and contact details
(a) General Information about Research
‘Consumers for Ethics in Research’ have produced a leaflet ‘Medical Research and
You’. This leaflet gives more information about medical research, and looks at
questions you may want to ask. A copy is attached.
(b) Specific Information about this Research Project
If you have any questions about this study, please contact a member of the research
team. These are:Wendy Robertson on Tel: 024 7657 4660, or Email: W.Robertson@warwick.ac.uk
Jo Kirby Tel: 024 7615 1853, or Email: FFH@warwick.ac.uk
Fran Poole, NHS Warwickshire, Tel 01926 493 491 ext 277
Email: francine.poole@nhs.net
Thank you for taking time to read this & for thinking about taking part.
8