Positive Online Weight Reduction Study (POWeR2)
| ISRCTN | ISRCTN21244703 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21244703 |
| Secondary identifying numbers | HTA 09/12/19, 11939 |
- Submission date
- 16/03/2012
- Registration date
- 16/03/2012
- Last edited
- 27/01/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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 (UK)
Who is the main contact?
Jo Kelly
jk1@soton.ac.uk
Contact information
Scientific
Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
| Phone | +44 (0)23 8024 1060 |
|---|---|
| jk1@soton.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Process of Care, Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Positive Online Weight Reduction Study (POWeR2): a randomised controlled trial |
| Study 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(s) | NRES Committee South Central Southampton B First MREC, 19/12/2011, ref: 11/SC/0455 |
| 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 |
| Primary outcome measure | 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 study start date | 01/02/2013 |
| Overall study end date | 02/09/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 700; UK Sample Size: 700; Description: 15-20 patients per practice from 44 practices |
| Participant inclusion criteria | Adult male and female patients with a body mass index (BMI) over 30 (or 28 with hypertension or or hypercholesterolaemia) |
| Participant exclusion criteria | 1. Current mental health problems 2. Very ill or unable to change diet 3. Pregnancy or breastfeeding 4. Perceived inability to walk 100 metres |
| Recruitment start date | 01/02/2013 |
| Recruitment end date | 02/09/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SO16 5ST
United Kingdom
Sponsor information
University/education
Head of Research Governance
Room 4055/Building 37
Southampton
SO30 3JB
England
United Kingdom
"ROR" |
https://ror.org/01ryk1543 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2016 | Yes | No | |
| Results article | results | 01/01/2017 | Yes | No |
Editorial Notes
27/01/2017: Publication reference added.
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.
