An electronic tool for the management of overweight children

ISRCTN	ISRCTN24468014
DOI	https://doi.org/10.1186/ISRCTN24468014
Secondary identifying numbers	12831

Submission date: 05/09/2012
Registration date: 10/09/2012
Last edited: 08/06/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The aim of this study is to test a new website to improve childhood obesity management in primary care and assess the need for a larger study. The website will guide a practice nurse or general practitioner (GP) through a consultation with an overweight child. It will prompt the health professional to collect information on the child and their lifestyle habits. The tool then uses this information to estimate a child’s current risk of having cardiovascular (heart disease) risk factors and emotional/behavioural difficulties, and to provide tailored weight management advice.

Who can participate?
The study population will be children and parents with concerns about the child’s weight (child age range: 5 to 18 years). We intend to recruit four GP practices in London, all of which will use the intervention.

What does the study involve?
Participants will attend a consultation with a health professional, who will use the website during the consultation. The health professional will take a few simple measurements from the child (height, weight and blood pressure) and will ask a series of questions regarding lifestyle habits. This information will be recorded by the tool, which will then identify children at an increased risk of having weight-related illnesses. The tool will also produce a weight and lifestyle management plan for the child. After the consultation is over, participants and health professionals will be asked to complete questionnaires about their experiences. In addition, individual interviews will be conducted with participants and health professionals to find out about their satisfaction with the consultation process and the acceptability of the website.

What are the possible benefits and risks of participating?
A potential benefit from taking part in this study is that participants will receive information about health risks and weight management that may help them make healthy lifestyle changes. A possible risk of study participation relates to risk predictions. Because the tool uses a prediction model to estimate a child's risk of having an illness, there is a chance for false positives (identifying a child as high risk when in fact the child is not at high risk) and false negatives (identifying a child as low risk when in fact the child is at high risk). This could lead to unnecessary subsequent medical testing or consultations, or fail to identify a high-risk child, respectively.

Where is the study run from?
London School of Hygiene & Tropical Medicine (UK).

When is the study starting and how long is it expected to run for?
The study ran from September 2012 to February 2013.

Who is funding the study?
National Institute for Health Research (NIHR) (UK).

Who is the main contact?
Áine Skow
aine.skow@lshtm.ac.uk

Contact information

Miss Aine Skow
Scientific

London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom

Email	aine.skow@lshtm.ac.uk

Study information

Study design	Non-randomised interventional trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	GP practice
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Evaluating a brief electronic tool to assist GPs and practice nurses in the identifying, managing and referring overweight children
Study objectives	The intended goal of this research is to aid in the management of childhood obesity by developing a simple electronic tool to assist primary care health professionals. This study will answer the question of whether an electronic tool for management of children with overweight is helpful to families and useful to health professionals. We hypothesise that patients and health professionals will be satisfied with consultations which employ the electronic childhood obesity management tool.
Ethics approval(s)	National Research Ethics Service Committee London - West London, 07/06/2012, ref: 11/LO/2049
Health condition(s) or problem(s) studied	Obesity
Intervention	The intervention is an electronic tool (website) which will guide a health professional through a consultation with an overweight child. The tool will prompt the health professional to take height and weight measurements and collect information on lifestyle behaviours. The tool then uses this information to: 1. Estimate a childs current risk of having certain cardiometabolic and mental health outcomes 2. Provide tailored weight management advice
Intervention type	Other
Primary outcome measure	Family satisfaction with consultation will be assessed immediately after consultation is complete.
Secondary outcome measures	1. Acceptability of the tool to the family assessed at completion of the consultation 2. Acceptability of the tool to the health professional assessed at the completion of each consultation 3. Health professional satisfaction with the consultation process assessed at completion of each consultation
Overall study start date	01/09/2012
Completion date	28/02/2013

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	5 Years
Upper age limit	18 Years
Sex	Both
Target number of participants	UK Sample Size: 40
Key inclusion criteria	1. All families presenting to primary care with concerns over the childs weight will be eligible to partake in the study, if children are between the ages of 5 and 18 years 2. Male and female participants
Key exclusion criteria	1. Due to the nature of the intervention, families who are not able to read and understand English will not be eligible for inclusion in the trial. 2. Children already under primary or secondary care for weight management
Date of first enrolment	01/09/2012
Date of final enrolment	28/02/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

London School of Hygiene and Tropical Medicine

London
WC1E 7HT
United Kingdom

Sponsor information

London School of Hygiene and Tropical Medicine (UK)
University/education

Keppel Street
London
WC1E 7HT
England
United Kingdom

Website	http://www.lshtm.ac.uk/
"ROR"	https://ror.org/00a0jsq62

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

08/06/2017: No publications found in PubMed, verifying study status with principal investigator