Positive Online Weight Reduction Study (POWeR)

ISRCTN	ISRCTN31685626
DOI	https://doi.org/10.1186/ISRCTN31685626
Protocol serial number	9575
Sponsor	University of Southampton (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0808-17077)

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

Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom

Email	seb4@soton.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised multicentre interventional prevention/process of care trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Weight, measured at baseline, one month and end of study (6 months)
Key secondary outcome measure(s)	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
Completion date	31/05/2013

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	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

United Kingdom
England

Study participating centre

Primary Medical Care

Southampton
SO16 5ST
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes