Condition category
Nutritional, Metabolic, Endocrine
Date applied
05/09/2012
Date assigned
10/09/2012
Last edited
05/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Miss Aine Skow

ORCID ID

Contact details

London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
-
aine.skow@lshtm.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12831

Study information

Scientific title

Evaluating a brief electronic tool to assist GPs and practice nurses in the identifying, managing and referring overweight children

Acronym

Study hypothesis

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

National Research Ethics Service Committee London - West London, 07 June 2012, ref: 11/LO/2049

Study design

Non-randomised interventional trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 child’s current risk of having certain cardiometabolic and mental health outcomes
2. Provide tailored weight management advice

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/09/2012

Overall trial end date

28/02/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. All families presenting to primary care with concerns over the child’s 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

UK Sample Size: 40

Participant 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

Recruitment start date

01/09/2012

Recruitment end date

28/02/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

London School of Hygiene and Tropical Medicine (UK)

Sponsor details

Keppel Street
London
WC1E 7HT
United Kingdom

Sponsor type

University/education

Website

http://www.lshtm.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

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

Publication citations

Additional files

Editorial Notes