Condition category
Nutritional, Metabolic, Endocrine
Date applied
17/04/2012
Date assigned
23/05/2012
Last edited
01/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and Study Aims:
POWeR stands for Positive Online Weight Reduction. It is a website based weight management programme, developed by researchers and health professionals at the University of Southampton.
The current project will look at if and how POWeR is used and whether it helps people to lose weight. It will also explore the role of brief telephone calls with a weight management coach in getting people to use the online programme and to lose weight.

Who can participate?
The study is open to adults who are overweight and who have access to the internet on a regular basis. People who are interested in the study can find out more at www.power-northeast.org. They will need to answer some quick questions online to check that POWeR will be suitable for them before they can sign up.

What does the study involve?
Participants first complete some brief online questionnaires. Then the website will randomly choose whether the participant has
1. Immediate access to POWeR
2. Immediate access to POWeR plus two brief telephone coaching sessions
3. Access to POWeR after 8 weeks
The POWeR website is a series of online modules which the participant is encouraged to complete on a weekly basis. The POWeR intervention guides and supports users in changing their eating and physical activity. There are no strict dietary or exercise prescriptions; participants set themselves achievable, graded goals. Every session comprises self-monitoring, goal setting and tailored feedback on progress. Additional content of sessions are around topics such as fitting weight mangement into daily life, emotional triggers for eating and gaining social support. Each session ends with personalised links to good online sources of information and advice about different aspects of weight managment. Skills and strategies developed in the sessions are saved for the user to access later; their 'POWeR tools'. After 8 weeks all participants will be sent an email asking them to complete some questionnaires about their weight and their experiences of using POWeR. Some users will be invited to talk to the researchers on their phone in detail about how they got on with POWeR.

What are the possible benefits and risks of participating?
Participants who follow the POWeR programme are likely to lose weight in a safe and gradual way. Risks to participants are not expected. Potential users with serious health problems will be asked to check with their GP about the suitability of making dietary and exercise changes before making such changes. Participants will be directed to their GP in the case of any health concerns arising during the study.

Where is the study run from?
From the University of Southampton but people take part via a website so can do this from home.

Who is funding the study?
Engineering and Physical Sciences Research Council

When is study starting and how long is it expected to run for?
The project starts in May 2012 and is expected to run until the end of September 2012.

Who is the main contact
Dr Laura Dennison
L.K.Dennison@soton.ac.uk
www.power-northeast.org [URL will work from June 2012 onwards]

Trial website

http://www.power-northeast.org

Contact information

Type

Scientific

Primary contact

Prof Lucy Yardley

ORCID ID

Contact details

Academic Unit of Psychology
University of Southampton
Highfield campus
Southampton
SO17 1BJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled trial of usage of an online weight management intervention by overweight/obese adults with and without human telephone support.

Acronym

POWeR

Study hypothesis

Does adherence to/engagement with a web weight management intervention, significantly increase due to the addition of minimal telephone-based human support?

This study explores uptake, usage, adherence and attrition within a web-based weight management programme when delivered with and without brief telephone-based human support

Ethics approval

University of Southampton Ethics Committee, 17 April 2012, ref: 1654

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

www.power-northeast.org

Condition

Overweight/obesity

Intervention

Participants have 8 weeks either Web only, Web plus coach support or control group. They are then followed up and complete self-report questionnaires.

Web Only
This group will be given immediate access to the POWeR website.
The POWeR website is a series of online modules which the participant is encouraged to complete on a weekly basis. The POWeR intervention guides and supports users in changing their eating and physical activity. Every session comprises self-monitoring, goal setting and tailored feedback on progress. Additional content of sessions are around topics such as fitting weight mangement into daily life, emotional triggers for eating and gaining social support. Each session concludes with personalised links to good online sources of information and advice about different aspects of weight managment. Skills and strategies developed in the sessions are saved for the user to access later; their 'POWeR tools'. Participants in this arm receive no human contact from the POWeR intervention.

Web + coach support
This group will be given immediate access to the POWeR website (described above). Participants in this arm also receive two brief telephone calls from a POWeR coach at week 1 and week 5.

Control group (waiting list with delayed Web access)
This group will be given no intervention for 8 weeks. Participants in this arm will be given access to the POWeR website after 8 weeks.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Participants’ use of POWeR weight management website (objective data, recorded by the online intervention):
1. Number of POWeR goal review sessions completed
2. Time spent on POWeR website (minutes)
3. Number of log-ons

Secondary outcome measures

Self-reported weight loss between baseline and 8 weeks (kilograms)

Overall trial start date

01/05/2012

Overall trial end date

30/09/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults, aged 18 or older
2. Self-reported BMI >23
3. UK resident
4. Able to access the internet on a regular basis
5. Able and willing to weigh self once per week

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

759

Participant exclusion criteria

Potential participants with health conditions that influence their diet or physical activity are advised to check with their GP before taking part

Recruitment start date

01/05/2012

Recruitment end date

30/09/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Unit of Psychology
Southampton
SO17 1BJ
United Kingdom

Sponsor information

Organisation

University of Southampton (UK)

Sponsor details

c/o Dr Martina Prude
Highfield Campus
Research Governance Office
Corporate Services
Southampton
SO17 1BJ
United Kingdom

Sponsor type

University/education

Website

http://www.southampton.ac.uk/

Funders

Funder type

Research organisation

Funder name

UBhave - UBiquitous and Social Computing for Positive Behaviour Change (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Engineering and Physical Sciences Research Council (UK) ref: EP/I032673/1

Alternative name(s)

EPSRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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/24681761

Publication citations

  1. Results

    Dennison L, Morrison L, Lloyd S, Phillips D, Stuart B, Williams S, Bradbury K, Roderick P, Murray E, Michie S, Little P, Yardley L, Does brief telephone support improve engagement with a web-based weight management intervention? Randomized controlled trial., J. Med. Internet Res., 2014, 16, 3, e95, doi: 10.2196/jmir.3199.

Additional files

Editorial Notes