ISRCTN - ISRCTN10921803: Is it feasible and acceptable to deliver HELPclinic (Healthy Eating Lifestyle Programme by Clinicians) in the medical office (outpatient) setting?

Plain English Summary

Background and study aims
A programme called HELPclinic has been developed for young people aged 12 to 18 who are obese. It is designed to be used by doctors, nurses and dieticians to help young people control their weight by changing the way they eat and exercise. This programme has been developed using an existing programme called HELP. The aim is to test this intervention for the first time to see whether it is possible to recruit young people and their families to join the study, to see whether they are able to complete the whole study, and to find out whether is possible for doctors, nurses and dieticians to deliver this type of programme in the outpatient clinic.

Who can participate?
Patients aged 12-18 who are obese

What does the study involve?
At the start of the study participants undergo blood tests and blood pressure measurement and complete quality of life and psychological questionnaires. All participants in this study attend five sessions of the HELPclinic programme at monthly intervals. Participants are then invited for an interview one month later to find out what they and their families think about the study. The doctors and nurses in the clinic who have been trained to deliver the programme are also interviewed to find out their views. The participants’ changes in weight and health are measured.

What are the possible benefits and risks of participating?
Possible benefits are the health benefits of having a healthy diet and increased levels of exercise. There are no anticipated risks associated with this study. The diet and lifestyle advice follows national recommendations and does not involve any unsafe diet or exercise plans.

Where is the study run from?
University College London Hospital (UK)

When is the study starting and how long is it expected to run for?
March 2010 to March 2013

Who is funding the study?
Institute of Child Health, University College London (UK)

Who is the main contact?
Dr Billy White
billy.white@ucl.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Billy White

ORCID ID

http://orcid.org/0000-0002-0109-6935

Contact details

University College London Hospital
250 Euston Road
London
NW1 2PG
United Kingdom
+44 (0)20 3447 9221
billy.white@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10/H0706/53

Study information

Scientific title

Healthy Eating Lifestyle Programme by Clinicians: a feasibility randomised control pilot trial

Acronym

Study hypothesis

This feasibility study is part of a research program that will examine the following hypotheses:
1. A family-based lifestyle intervention, delivered by clinicians (doctors, nurses and dieticians) using two psychological techniques (solution-focused therapy and motivational interviewing) is efficacious in reducing body mass index.
2. The intervention is efficacious in improving quality of life, reducing waist circumference and cardiometabolic risk factors and improving psychological function in obese adolescents.

This study will:
1. Establish feasibility and acceptability of recruitment, randomisation and delivery of the program.
2. To obtain estimates of outcomes to plan a full randomised control trial.

Ethics approval

West London REC3 NRES Committee, 17/09/2010, ref: 10/H0706/53

Study design

Randomised control trial, subsequently adapted to a pre-post observational study

Primary study design

Observational

Secondary study design

Pre-post study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Obesity

Intervention

All participants in this study undertake the HELPclinic intervention, a five-session individual lifestyle programme delivered at monthly intervals. The lifestyle intervention uses behavioural tools from motivational interviewing and solution-focused therapy to enable behaviour change aligned with contemporary dietary and exercise recommendations. It was originally planned to undertake a waiting-list control randomised control trial where half of the participants would wait 5 months to start the intervention. This was subsequently changed to an observational study where all participants undertake the study immediately at the time of entry into the study. All participants are invited for review one month after the intervention by their referring clinician.

Baseline measurements are taken at baseline to characterise the sample: cardio-metabolic measurements (HbA1c or oral glucose tolerance test, blood pressure measurement, lipids), quality of life and psychological function measurements (SDQ, PedsQL, RSE, EDEQ and DEBQ questionnaires) and auxology measurements (height and weight). Height and weight measurements are repeated at each session.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Feasibility - recruitment, attendance and attrition rates are continually monitored in order to test the ability to recruit and retain participants
2. Acceptability - qualitative interviews are performed with participants and clinicians after 6-12 months of study completion

Secondary outcome measures

Change in BMI over the course of the programme: height and weight are measured at each session and 1 month after completion of the programme

Overall trial start date

01/03/2010

Overall trial end date

01/03/2013

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 12-18 years
2. Male and female
3. BMI between 98th centile and 45kg/m2

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Subjects with significant mental health problems or undergoing mental health treatment
2. Other chronic illness, monogenic obesity syndrome or use of medications known to promote obesity
3. Patients who have signs or symptoms which require them to have immediate investigations, e.g. diabetes
4. Participants with significant learning disability or lack of command of English sufficient to render them unable to participate effectively in the planned intervention. The great majority of eligible young people from black or minority ethnic groups in this population have good command of English. Given the importance of standardising the intervention, it will not be possible to use interpreters to enable parents with poor English to participate. We will ensure that the external validity of the study is maintained by allowing another relative with good English to participate
5. BMI>45 kg/m2 as they are unlikely to respond to lifestyle changes alone
6. Participants who have been involved in a weight management research program greater than 12 months previously will be eligible but those who are actively involved in a weight management program will be excluded

Recruitment start date

17/10/2010

Recruitment end date

03/04/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London Hospital
250 Euston Road
London
NW1 2PG
United Kingdom

Sponsor information

Organisation

University College London Hospital

Sponsor details

250 Euston Road
London
NW1 2PG
United Kingdom
+44 (0)207 380 9833
billy.white@ucl.ac.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

Institute of Child Health, University College London

Alternative name(s)

ICH

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location