Contact information
Type
Scientific
Primary contact
Mrs Susan Broomfield
ORCID ID
Contact details
Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
seb4@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
9575
Study information
Scientific title
Positive Online Weight Reduction Study (POWeR): a randomised multicentre interventional prevention/process of care trial
Acronym
POWeR
Study hypothesis
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
IOW, Portsmouth and SE Hampshire Research Ethics Committee approved on the 13th September 2010 (ref: 10/H0501/46)
Study design
Randomised multicentre interventional prevention/process of care trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Prevention
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
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/12/2010
Overall trial end date
31/05/2013
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Planned sample size: 265
Participant 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)
Recruitment start date
01/12/2010
Recruitment end date
31/05/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Primary Medical Care
Southampton
SO16 5ST
United Kingdom
Sponsor information
Organisation
University of Southampton (UK)
Sponsor details
Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0808-17077)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24886516
Publication citations
-
Results
Yardley L, Ware LJ, Smith ER, Williams S, Bradbury KJ, Arden-Close EJ, Mullee MA, Moore MV, Peacock JL, Lean ME, Margetts BM, Byrne CD, Hobbs RF, Little P, Randomised controlled feasibility trial of a web-based weight management intervention with nurse support for obese patients in primary care., Int J Behav Nutr Phys Act, 2014, 11, 67, doi: 10.1186/1479-5868-11-67.