Condition category
Nutritional, Metabolic, Endocrine
Date applied
07/08/2013
Date assigned
18/09/2013
Last edited
18/11/2016
Prospective/Retrospective
Prospectively 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. This study will look at how POWeR is used and whether it helps people to lose weight.

Who can participate?
Adults in participating worksites who are overweight and who have access to the internet on a regular basis. 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 register by creating an account with POWeR and complete some brief online questionnaires. They are then granted 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. 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 management 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 management. Skills and strategies developed in the sessions are saved for the user to access later - their 'POWeR tools'. Participants who have smartphones can download an accompanying POWeR ‘app’ to track their goals and progress.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 by 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 doctor about the suitability of making dietary and exercise changes before making such changes. Participants will be directed to their doctor in the case of any health concerns arising during the study.

Where is the study run from?
The study is run from the University of Southampton but people take part via a website so can do this from their own home, workplace or other convenient location.

Who is funding the study?
The study is supported by a grant from the Engineering and Physical Sciences Research Council (EPSRC).

When is the study starting and how long is it expected to run for?
The study will start in October 2013 and is expected to run until the end of February 2014.

Who is the main contact?
Dr Laura Dennison, School of Psychology, University of Southampton
L.K.Dennison@soton.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Lucy Yardley

ORCID ID

http://orcid.org/0000-0002-3853-883X

Contact details

University of Southampton
Highfield Campus
Southampton
SO171BJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

6155

Study information

Scientific title

Uptake and usage of a web and smartphone-delivered weight management intervention by overweight / obese adults in UK workplaces

Acronym

Study hypothesis

This study rolls out a web-based intervention in a real-life context to examine research questions centering around: demographic and employment-related predictors of usage, satisfaction with the web and smartphone elements of the intervention, and the role of the workplace climate in engaging with the intervention, and self-reported weight loss.

Ethics approval

University of Southampton Ethics Committee, 09/05/2013, ref: 5992

Study design

Observational study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Other

Trial type

Screening

Patient information sheet

Condition

Overweight / obesity

Intervention

Web-based intervention is offered to employees in participating UK workplaces.

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 management 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 management. Skills and strategies developed in the sessions are saved for the user to access later; their 'POWeR tools'. Participants who have smartphones can download an accompanying POWeR ‘app’ to track their goals and progress.

Data collection at baseline (registration) and 8 weeks.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Participants’ use of POWeR weight management website (objective data, recorded by the online intervention). Data collection at baseline (registration) and 8 weeks.

Secondary outcome measures

Satisfaction with the website and (where relevant) smartphone app (enter questionnaires to be used).

Other measures of interest include:
1. Satisfaction with the website (Yardley et al. 2010)
2. Use of the POWeR intervention within the workplace context (questionnaire created specifically for this study)
3. Workplace weight related social norms (Lemmon et al. 2013)
4. Workplace health climate (Ribisl & Reischl., 1993)
5. Self-reported weight loss (kgs)

Data collection at baseline (registration) and 8 weeks.

Overall trial start date

01/10/2012

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults (male and female), aged 18 or older
2. Self-reported body mass index (BMI) >23
3. Able to access the internet on a regular basis
4. Able and willing to weigh self once per week

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

We aim to explore uptake and adherence and their correlates in the context of a real life public health rollout of the intervention. We therefore do not have a minimum or maximum no. of participants.

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

01/01/2014

Recruitment end date

31/12/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Southampton
University Road
Southampton
SO171BJ
United Kingdom

Sponsor information

Organisation

University of Southampton (UK)

Sponsor details

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

Sponsor type

University/education

Website

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

Funders

Funder type

Research council

Funder name

Engineering and Physical Sciences Research Council (EPSRC) - Project UBhave: ubiquitous and social computing for positive behaviour change, ref: EP/I032673/1

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results from preliminary data analyses have been presented to the academic community at national and international conferences. Data analyses are ongoing and a publication summarising the main findings will be prepared and submitted in due course.

IPD Sharing plan:
Anonymised participant-level data from the trial will be made available following publication. This data will deposited in the University of Southampton data repository and will be accessible to bona fide researchers on request.

Intention to publish date

31/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/11/2016: The publication and dissemination plan, availability of participant level data, are target number of participants have been added. In addition, the overall trial dates have been updated from 01/10/2013 - 28/02/2014 to 01/10/2012 - 31/12/2015 and the recruitment dates have been updated from 01/10/2013 - 28/02/2014 to 01/01/2014 - 31/12/2014. 27/09/2016: No publications found, verifying study status with principal investigator