Positive Online Weight Reduction Study (POWeR)
| ISRCTN | ISRCTN31685626 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31685626 |
| Secondary identifying numbers | 9575 |
- Submission date
- 02/02/2011
- Registration date
- 02/02/2011
- Last edited
- 03/06/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Susan Broomfield
Scientific
Scientific
Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
| seb4@soton.ac.uk |
Study information
| Study design | Randomised multicentre interventional prevention/process of care trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Positive Online Weight Reduction Study (POWeR): a randomised multicentre interventional prevention/process of care trial |
| Study acronym | POWeR |
| Study objectives | Obesity is a major and rapidly rising public health threat. Recent NICE guidelines provide recommendations to implement lifestyle changes (diet and exercise) supported by behavioural techniques. Unfortunately, an average practice will have more than 1000 patients with obesity, and most practice staff have neither the training nor the time to implement intensive obesity management programmes based on 1:1 counselling, or even group counselling, to cope with such numbers. The problem will become worse as the obesity epidemic progresses. By providing an intervention which requires fewer resources for training and for intervention this study will allow a much greater group of patients to benefit both locally and nationally. We have developed written behavioural manuals for both patient and practitioner. This study will create a less resource intensive intervention to support behavioural change by converting these materials into web format, taking advantage of a grant to our group which supports the development of generic web programming for behavioural interventions. After materials have been converted to web format, and are acceptable to patients and practitioners, we will then explore the impact of different levels of nurse support required to achieve effective weight change. |
| Ethics approval(s) | IOW, Portsmouth and SE Hampshire Research Ethics Committee approved on the 13th September 2010 (ref: 10/H0501/46) |
| Health condition(s) or problem(s) studied | Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases |
| Intervention | Phase 1: Study 1: In-depth interviews will be carried out with up to 30 patients from 3 - 4 GP practices to elicit views of the intervention materials (including reactions to content and usability). Study 2: Up to 5 focus groups will be held for health professionals with practice nurses and GPs from 10 - 20 practices. Participants will be invited to use the training materials and patient website prior to taking part in the focus group to stimulate discussion of the issues relating to content, format and feasibility. Phase 2: Pilot RCT: Patients will be offered: 1. Web access and email support 2. Minimal face to face support 3. Intensive face to face visits 4. Normal care GP records will be reviewed for cost-effectiveness. |
| Intervention type | Other |
| Primary outcome measure | Weight, measured at baseline, one month and end of study (6 months) |
| Secondary outcome measures | 1. EQ5D, measured at baseline, one month and 6 months 2. Food Frequency Questionnaire, measured at baseline, one month and 6 months 3. Godin Leisure Time Physical Activity Questionnaire, measured at baseline, one month and 6 months 4. GP record review, measured at the end of the study 5. Physical measurements, measured at baseline, one month and 6 months |
| Overall study start date | 01/12/2010 |
| Completion date | 31/05/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | Planned sample size: 265 |
| Key inclusion criteria | 1. Patients aged over 18 years, either gender 2. Body mass index (BMI) greater than or equal to 30 (or 28 with hypertension or hypercholesterolaemia) documented in the GP case records |
| Key exclusion criteria | 1. Current major mental problems (difficulty completing outcomes) 2. Very ill/unable to change diet (e.g. severe left ventricular failure [LVF]) 3. Pregnancy/breast feeding 4. Perceived inability to walk 100 metres (i.e. physical activity difficult) |
| Date of first enrolment | 01/12/2010 |
| Date of final enrolment | 31/05/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Primary Medical Care
Southampton
SO16 5ST
United Kingdom
SO16 5ST
United Kingdom
Sponsor information
University of Southampton (UK)
University/education
University/education
Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
England
United Kingdom
| Website | http://www.soton.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/01ryk1543 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0808-17077)
No information available
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 | 21/05/2014 | Yes | No |
