Condition category
Nutritional, Metabolic, Endocrine
Date applied
03/05/2013
Date assigned
03/05/2013
Last edited
16/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
One important step in decreasing the prevalence of children becoming overweight is to help families accurately recognise their child’s weight status so they appreciate the need to take appropriate action or seek support. The clinical criteria for overweight are typically based on the body mass index (BMI) but evidence suggests that parents use visual methods rather than those based on BMI. This research team has developed a visual intervention tool which has age and gender-specific body image scales (ranges of images of body shapes of known BMI from underweight to obese) and supporting information about the health risks of childhood overweight (Map Me). A study will be conducted to find out if the Map Me intervention helps parents accurately identify their child’s weight status, whether it influences knowledge and action taken. The study is entitled the ‘4 & UPP Study’.

Who can participate?
Parents of school children aged 4-5 years (Reception) and 10-11 years (Year 6). The parent’s child will also be a participant. In cases where families have more than one eligible child, one will be selected at random by the study team.

What does the study involve?
Schools will be randomly allocated to: provision of Map Me in paper-based format; provision of Map Me in web-based format; or provision of no information (control). Comparison will be made between both intervention groups and the control group to determine effectiveness of the intervention.
Parents will complete a questionnaire with measures of their perception of their child’s weight status and other aspects primarily about knowledge of the health consequences of childhood overweight and cognitive characteristics (child's development in terms of information processing, language learning, and other aspects of brain development) around facilitating weight control in their children. Parents in the intervention groups will have access to Map Me for one month prior to completing the questionnaire. The study team will work with National Child Measurement Programmes (NCMP), which measures the height and weight of Reception and Year 6 children and with parental consent will obtain the measures. The aim will be to obtain the questionnaire data for the study before parents receive the feedback letter from the NCMP informing them of the weight status of their child. Parents and children will be followed-up at 12 months; parents will be asked to complete a questionnaire similar to the first, and both parent and child will be measured by the study team for height and weight.

What are the possible benefits and risks of participating?
There is potential direct benefit to parents in the intervention groups in relation to perception of their child’s weight status and health risks. Indirectly children may benefit due to increased parental awareness of childhood obesity. Those not in the intervention groups may be disadvantaged but will be given access to the intervention if it is shown to be effective and becomes publicly available (prior agreement confirmed with NHS Choices). There are no risks highlighted in taking part in the study.

Where is the study run from?
The study is run from the Institute of Health & Society at Newcastle University, England, UK.

When is study starting and how long is it expected to run for?
February 2013 to April 2015.

Who is funding the study?
The trial is funded by the National Prevention Research Initiative, website (http://www.npri.org.uk). The Funding Partners are: Alzheimer's Research Trust; Alzheimer's Society; Biotechnology and Biological Sciences Research Council; British Heart Foundation; Cancer Research UK; Chief Scientist Office, Scottish Government Health Directorate; Department of Health; Diabetes UK; Economic and Social Research Council; Health and Social Care Research and Development Division of the Public Health Agency (HSC R&D Division); Medical Research Council; The Stroke Association; Wellcome Trust; Welsh Assembly Government; and World Cancer Research Fund.

Who is the main contact?
Professor Ashley Adamson
ashley.adamson@ncl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ashley Adamson

ORCID ID

Contact details

Institute of Health and Society
4th Floor William Leech Building
Framlington Place
Newcastle Upon Tyne
NE2 4HH
United Kingdom
-
ashley.adamson@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14008

Study information

Scientific title

Cluster randomised trial on Improving Recognition of Childhood Overweight

Acronym

4 & UPP Study

Study hypothesis

4 & UPP Study - Understanding Parents’ Perceptions” - children aged 4 and above

Preventing excess body weight in childhood is a public health priority. Parents are essential in achieving this but they often do not recognise when their child is overweight and consequently do not take action. Improving parental recognition of childhood overweight is essential to behaviour change. We have developed gender-specific body image scales of known body mass index for 4-5 and 10-11 year olds and supporting information about the health consequences of childhood overweight. This full cluster randomised trial (CRT) will test the developed tools designed to help parents identify their child’s body weight status. The outcome measures are accuracy of parent perception of child weight status and change in child weight status over one year.

A minimum of 36 schools will provide a sample of parents (one parent per child) of 4-5 and 10-11 year children (target n=2160). The schools will be randomised to either: Intervention A-provided with paper-based tools and supporting information with techniques about identifying overweight in children and why it is important; Intervention B-the same but web-based; Control group. Parents in all arms will be asked to complete a questionnaire which includes assessment of their child’s weight status, perceived behavioural control, action planning and related topics. Parent body measurements will be obtained. We will work with the National Child Measurement Programme (NCMP) in North of Tyne PCT which collects height and weight of Reception and Year 6 children. We will obtain these data to avoid duplicate measures of children, and crucially will provide the means to assess parents' accuracy of child weight status before parents receive the NCMP feedback letter informing them of their child's results (i.e. weight status). At 12 month follow-up parents will complete a postal questionnaire, and children's height and weight measured at school or home visit by the study team.

More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=14008

Ethics approval

NRES Committee North East - Newcastle & North Tyneside 2, First MREC approval date 21/11/2012, 12/NE0409

Study design

Cluster randomised interventional trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Treatment

Patient information sheet

Not available in web format. The parents’ letter and information sheet can be requested from: Dr Kathryn Parkinson by emailing kathryn.parkinson@ncl.ac.uk or by telephone on +44 191 222 3828.

Condition

Topic: Generic Health Relevance and Cross Cutting Themes; Disease: Paediatrics / Childhood Overweight

Intervention

Parents of children in two age groups (4-5 years; 10-11 years). Their children will also be participants. The sample will be drawn from schools. A minimum of 36 schools with 120 children per school (2 classes of 30 in each of two year groups) will provide a sampling frame of 4320 children. Anticipating 50% agreeing to participate, provides a sample of 2160.

If some enrolled schools are smaller or take-up rate is lower than 50%, more schools will be enrolled.

Non-invasive information based, Delivery of body image scales and supporting information to parents to improve recognition of childhood obesity

Three study arms: delivery via web tool, paper-based and control.

The duration of the intervention is 30 days.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Change in parental perceptions of child body weight measured 1 month and 12 months post-intervention delivery

Secondary outcome measures

Child weight status at 12 months follow-up

Overall trial start date

25/02/2013

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. The parent must have a child in Reception or Year 6 of a school enrolled to the study
2. Male & Female, lower age limit 4 years

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

UK Sample Size: 2160

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

25/02/2013

Recruitment end date

31/12/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Health and Society
Newcastle Upon Tyne
NE2 4HH
United Kingdom

Sponsor information

Organisation

Newcastle University (UK)

Sponsor details

Institute of Health and Society
21-23 Claremont Place
Newcastle Upon Tyne
NE2 4AA
United Kingdom

Sponsor type

University/education

Website

http://www.ncl.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) Grant Codes: MR/J00054X/1

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26068921

Publication citations

Additional files

Editorial Notes