Condition category
Nutritional, Metabolic, Endocrine
Date applied
05/02/2013
Date assigned
27/03/2013
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 and smartphone-based weight management tool, developed by researchers, health professionals, and computer scientists at the University of Southampton (UK). The study will look at how different people use the web and smartphone-based POWeR tools.

Who can participate
The study is open to adults who have access to the Internet on a regular basis. Notifications that the POWeR programme is ready to use will be send to users of the myPersonality Facebook application, but you do not have to be a myPersonality user to take part.
You will need to answer some quick online questions to check that POWeR will be suitable before you can sign up.

What does the study involve?
To sign up to the study you will need to create an account with POWeR and answer some brief online questionnaires. You will then be able to use the POWeR website.
The POWeR website has 12 different topics that you can look at on a weekly basis. POWeR will guide and support you to change your eating and physical activity patterns. There are no strict rules – you are free to set your own achievable goals. Topics include fitting weight management into daily life, emotional triggers for eating and gaining social support. Each topic ends with personalised links to other good online sources of information and advice about different aspects of weight management. POWeR Tools will help you to develop skills and strategies for weight management – these will be saved for you to use again at anytime you want.
If you have an Android Smartphone you can also download the POWeR Tracker app. This will help you to keep track of your goals and progress.
After 8 weeks you will be sent an email inviting you to tell us more about your experiences of using POWeR and what you thought of POWeR. You’ll also have the chance to talk to one of the research team on the phone about how you got on with POWeR (if you want to).

What are the possible benefits and risks of participating?
People who follow POWeR are guided to manage their weight in a safe and gradual way.
If you have a health condition or problem you must check with your GP about the suitability of making dietary and exercise changes before using POWeR.
Participants will be directed to their GP in the case of any health concerns arising during the study.

Where is the study run from?

The study is run by research teams at the University of Southampton and the University of Cambridge. You can take part from your own home, workplace or other location where you have regular access to the Internet.

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

When is study starting and how long is it expected to run for?
The project starts in February 2013 and is expected to run until the end of 2013.

Who is the main contact
Dr Leanne Morrison
powerethicsquestions@soton.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Leanne Morrison

ORCID ID

http://orcid.org/0000-0002-9961-551X

Contact details

Academic Unit of Psychology
Shackleton Building
Highfield Campus
University of Southampton
SO17 1BJ
Southampton
SO17 1BJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Dissemination of a digital weight management intervention to adult users of the myPersonality Facebook application: An exploration of the role of personality and social influence on intervention uptake, adherence and health-related outcomes

Acronym

Study hypothesis

This study will disseminate a digital weight management intervention, containing web and Smartphone-based components, via the ‘MyPersonality’ Facebook application. The study will examine research questions centring around:
1. Intervention uptake, adherence, and usage patterns
2. Change in health-related outcomes (e.g. self-regulatory cognitions)
3. Differences between the web and Smartphone-based components
4. Whether personality and social influence variables predict uptake, usage, and health-related outcomes

Note: Countries of recruitment - Since our study will disseminate a weight management intervention via Facebook it is very difficult to specify what countries participants will be recruited from. UK and USA have been selected as we anticipate that the majority of participants are likely to be recruited from these two geographic locations. However, the participants may come from any country.

Ethics approval

University of Southampton Ethics Committee and Research Governance office, 04/03/2013, ref: 5182

Study design

Non-randomised interventional uncontrolled implementation study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Since one of the aims of this study is to assess intervention uptake using dissemination via myPersonality we are not providing a URL to members of the public.

Condition

Overweight / obesity

Intervention

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. Participants who have smartphones can download an accompanying POWeR app to track their goals and progress. New POWeR content is provided over a period of 12 weeks. Participants are free to continue using POWeR to track their weight and goals up to 1 year. Participants will be asked to complete self-report follow-up measures, online, 8 weeks post-baseline. No randomisation processes were used since this is an observational study.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Intervention use (automatically recorded data on log-ins, page views, and duration of views of the web and smartphone interventions);
2. Intrinsic Motivation (The Treatment Self-Regulation Questionnaire-Modified, Levesque et al. 2007) at baseline
3. Social norms for weight management (Adapted version of social norms scales by Lemmon et al. In Press) at baseline and 8 weeks;
4. Number and type of social ties also managing weight at baseline
5. Number and type of social ties also using POWeR at 8 weeks
6. Personality (NEO personality inventory, McCrae & Costa 1987)
7. Action control for dietary behaviour and physical activity (measure adapted from Sniehotta et al., 2005) at baseline and 8 weeks;
8. Automatically recorded data on smartphone use, sensed by smartphone (e.g. number of calls, number of SMS, current time/location, power status etc.)
9. Positive Intervention Perceptions (Yardley et al., 2010) at 8 weeks
10. Perceived ease of use (Venkatesh & Davis, 2000)
11. Self-reported smartphone usage at baseline
12. Preferences for POWeR use via website or Smartphone and /or reasons for non-use at 8 weeks
13. Self-reported weight at baseline and 8 weeks

Secondary outcome measures

No secondary outcome measures

Overall trial start date

25/02/2013

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults, aged 18 or older, either sex
2. Self-reported BMI > 19
3. Able to access the internet on a regular basis

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Uptake of the intervention when disseminated via Facebook is one of our main research questions. We therefore do not have a target number 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.

POWeR is currently also being evaluated in an ongoing clinical trial in specific areas within the UK. Participants who reside in these areas will be excluded from taking part.

Recruitment start date

08/05/2013

Recruitment end date

30/08/2013

Locations

Countries of recruitment

United Kingdom, United States of America

Trial participating centre

University of Southampton
Academic Unit of Psychology University Road
Southampton
SO17 1BJ
United Kingdom

Trial participating centre

University of Cambridge
Department of Psychology Downing Street
Cambridge
CB2 3EB
United Kingdom

Sponsor information

Organisation

University of Southampton (UK)

Sponsor details

c/o Dr Martina Prude
Research Governance Office
Highfield Campus
Southampton
SO192DX
United Kingdom

Sponsor type

University/education

Website

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

Funders

Funder type

Research council

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 (EPSRC) EP/I032673/1 (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Due to poor recruitment rates there are no plans to publish or disseminate findings from this trial.

IPD Sharing plan:
Due to poor recruitment rates the participant level data for this study will not be available.

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/11/2016: The recuritment dates have been updated from 25/02/2013 - 31/12/2013 to 08/05/2013 - 30/08/2013. In addition, the publication and dissemination information and information relating to the availability of participant level data has been added. 06/09/2016: No publications found in PubMed, verifying study status with principal investigator.