Condition category
Nutritional, Metabolic, Endocrine
Date applied
02/02/2011
Date assigned
02/02/2011
Last edited
03/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.soton.ac.uk/

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

  1. 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.

Additional files

Editorial Notes