Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/03/2012
Date assigned
16/03/2012
Last edited
01/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Obesity is a growing major threat to public health, but there is limited evidence for interventions that could easily be applied, with relatively little training, in primary care, where most obesity is managed. The internet could potentially provide an ideal way to give patients interactive advice based on their personal situation and progress, with the support of a nurse to oversee, encourage, advise patients as necessary.
Among obese patients in primary care, we aim to estimate the effectiveness and cost-effectiveness of a) an internet based behavioural intervention with face to face support as needed and b) an internet behavioural intervention with minimal face to face support.

Who can participate?
If you are registered with one of the recruiting GP practices you may be written to, or your general practitioner (GP) or Practice Nurse may ask you if you would like to take part if you attend an appointment with them. You must have a Body Mass Index (BMI) of over 30 or 28 with high blood pressure or high cholesterol, to take part in the study.

What does the study involve?
In order to take part in this study you must have regular access to the internet at home, at work or possibly a public place such as a library. First of all you will attend a screening appointment with your practice nurse, where some measurements will be made and a blood sample taken. All patients in the study will have these same measurements made again 6 months and 12 months after this first appointment. There are three possible groups that you could be randomly allocated to:
Web Intervention with nurse support- if in this group you will use the POWeR2 website and also visit the practice nurse at 2 weeks, 6 weeks and 3 months after the first visit. You may have four extra visits if needed. Web intervention with minimal nurse support – if in this group you will use the POWeR2 website and have a brief visit with the practice nurse at 2 weeks and then have three online contacts from the nurse at 1, 2, and 3 months and up to 2 telephone calls. Very brief advice and follow up – if you are in this group the practice nurse will give you some brief advice about a healthy diet and physical activity. You will only visit the practice nurse at 6 and 12 months for weight measurement and a blood sample.

What are the possible benefits and risks of participating?
By taking part in this study there is a chance that you will lose weight. Making gradual changes to your diet or physical activity levels should not present any risks to you, although if you are diabetic you may need to alter your medications, your practice nurse will advise you if this is necessary. If you have any questions or concerns about your health or your medications while on the programme, the practice nurse will be available to advise you.

Where is the study run from?
The study is co-ordinated from the Dept. of Primary Medical Care, University of Southampton. Patients will be recruited from about 44 practices within Southern England.

When is the study starting and how long is it expected to run for?
The study will begin recruiting patients from February 2013, for 6 months. Patients recruited into the study will be in the study for 12 months.

Who is funding the study?
National Institute for Health Research (NIHR) Health Technology Assessment Programme

Who is the main contact?
Jo Kelly
jk1@soton.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Joanne Kelly

ORCID ID

Contact details

Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
+44 (0)23 8024 1060
jk1@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 09/12/19, 11939

Study information

Scientific title

Positive Online Weight Reduction Study (POWeR2): a randomised controlled trial

Acronym

POWeR2

Study hypothesis

Among obese patients in primary care, to estimate the effectiveness and cost-effectiveness of
1. An internet based behavioural intervention with face to face support as needed and
2. An internet behavioural intervention with minimal face to face support

This is the resulting randomised trial from the pilot study registered under ISRCTN31685626.

Ethics approval

NRES Committee South Central – Southampton B First MREC, 19/12/2011, ref: 11/SC/0455

Study design

Randomised; Interventional; Design type: Process of Care, Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

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

Condition

Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases

Intervention

1. Control, very brief advice and follow up
2. Web and minimal nurse support, minimal face to face contact with nurse;
3. Web and nurse support, Web intervention with intensive nurse support
Follow-up length: 12 month(s); study entry: single randomisation only

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Outcome measure (08/12/2015):
1. The average weight reduction over 12 months, measured blind to randomisation group using Tanita digital scales measured at baseline, 6, and 12 months.
2. A secondary analysis of weight is the number of individuals who maintain a clinically important 5% weight reduction measured using Tanita digital scales measured at 6 and 12 months.


Original outcome measure:
Weight measured at baseline, 6, and 12 months

Secondary outcome measures

1. Food and drink consumption measured using Food Frequency Questionnaires at baseline, 6, and 12 months
2. Physical activity measured using the Godin physical activity questionnaire at baseline, 6, and 12 months
3. Waist circumference in cm measured by tape measure at baseline, 6, and 12 months
4. Blood pressure (BP) in mm Hg measured using a validated Omron device at baseline, 6, and 12 months
5. Serum Glucose and HbA1c in mmol/l measured at baseline, 6, and 12 months
6. Serum lipids (cholesterol/HDL/LDL/triglyceride) in mmol/l measured at baseline, 6, and 12 months
7. Body composition measured using Tanita digital scales to document percentage body fat measured at baseline, 6, and 12 months
8. Serum Liver function tests (AST,ALT,GGT) measured in IU/l to monitor non-alcoholic fatty liver disease at baseline, 6, and 12 months
9. Serum Ferritin in ug/l measured at 12 months
10.A modified version of the Patient Enablement Instrument measured by self-report questionnaire at baseline and 12 months
11. EQ-5D for Health economic analyses measured by self-report questionnaire at baseline, 6, and 12 months.
12. Health service resource use measured from documentation in the medical records in the 12 months prior to randomisation and the 12 months following
13. Reported activities undertaken to lose weight measured by self-report questionnaire at 12 months

Overall trial start date

01/02/2013

Overall trial end date

02/09/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Adult male and female patients with a body mass index (BMI) over 30 (or 28 with hypertension or or hypercholesterolaemia)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 700; UK Sample Size: 700; Description: 15-20 patients per practice from 44 practices

Participant exclusion criteria

1. Current mental health problems
2. Very ill or unable to change diet
3. Pregnancy or breast feeding
4. Perceived inability to walk 100 metres

Recruitment start date

01/02/2013

Recruitment end date

02/09/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Aldermoor Health Centre
Southampton
SO16 5ST
United Kingdom

Sponsor information

Organisation

University of Southampton (UK)

Sponsor details

Head of Research Governance
Room 4055/Building 37
Southampton
SO30 3JB
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme (ref: 09/12/19)

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

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

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27474214

Publication citations

Additional files

Editorial Notes

01/08/2016: Publication reference added. 08/12/2015: the primary and secondary outcomes were updated to include further details than was included in the original record. Additionally, secondary outcome measures 6-12 have been added, as they were unintentionally omitted on the original record, and outcome 13 has been added, which was not specified in the original protocol.