PARTICIPANT INFORMATION SHEET

Randomised Controlled Trial of ‘Families for Health’:

a family-based intervention for children who are overweight

Version 1 (Parents) - Dated 28/7/11 (Coventry)

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:

Part 1 of the Information Sheet

1.What is the purpose of the study?

Being overweight is becoming more commonin 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. Thisfamily centredprogramme has undergone pilotingbut it is now important to assess whether it is effective in a more rigorous study design, known as a Randomised Controlled Trial. 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.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 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 paperabout the research, or to a story on the radio, because you and your child are interested in taking part.

4.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.

5.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 available in Coventry. The groups are selected by a computer, and each family has a 1 in 2 chance of getting the ‘Families for Health’ intervention.

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.

Additional Measurements with the ‘Families for Health’ Group only

  • Each parent will be asked to complete a questionnaire about their experiences of the ‘Families for Health’ programme, at the end of the intervention.
  • 24 parents and their children will be interviewed at the end of the programme to obtain their experiences of the programme and its impact on them. The interviews will be tape-recorded ifparent’s consent is given.
  • At 12-month follow-up, the 24 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 ata community venue in Coventry (e.g. school, youth club, leisure centre).

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.

6. Payments

As a ‘thank-you’ for participation in the research, each family will be given £15 at each of the three measurement points.

7.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 Coventry.

8.What are the alternatives for treatment?

Coventry’s ‘One Body One Life’ (OBOL): a free 12 week programme that includes weight management, healthy eating and physical activity, for people 5 years and over.

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.

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.

11.What happens when the research study stops?

In each Primary Care Trustthe 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.

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 / NHS Coventry
Wendy Robertson
Associate Professor
Warwick Medical School
University of Warwick
Coventry
CV4 7AL
Tel: 024 7657 4660
Email: / Kate Reddington
Coventry’s Healthy Weight Co-ordinator
NHS Coventry - Public Health
Civic Centre 1
Little Park Street
Coventry
CV1 5RS
Tel: 024 7683 3354
Email:

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:

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 databaseheld 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.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 beenset upto oversee the research. This committee hastwo 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:

Beckie Lang on Tel: 024 7615 1853, or Email:

Kate Reddington, NHS Coventry, on Tel: 024 7683 3354, or

Email:

Thank you for taking time to read this & for thinking about taking part.

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