Condition category
Mental and Behavioural Disorders
Date applied
12/01/2017
Date assigned
01/02/2017
Last edited
30/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Positive mental health and wellbeing are a priority both in the UK and globally, evidenced by an increase in policy documents focused on population wellbeing. For example, mental health is a Welsh Government (WG) priority area. ‘Our Healthy Future’ and ‘Together for Mental Health’, Wales’s mental health strategy, states promoting better mental wellbeing as a key strategic objective. There is limited research exploring the role of emotional wellbeing programmes on physical health behaviour change programmes and health outcomes. This study represents one of the first to explicitly explore the additional benefit of an emotional wellbeing program on physical health behaviour change programs which aim to improve individual’s health outcomes. The aim of this study is to assess the acceptability to participants of including an emotional wellbeing module within the champions for health programme.

Who can participate?
Staff at Abertawe Bro Morgannwg University Health Board.

What does the study involve?
The study involves taking part in a web-based, work place health promotion programme designed to support public sector staff in Wales to improve their lifestyle and health behaviours. Participants are randomly allocated to either one of two groups. Those in the first group receive access to the five physical health promotion modules only. Those in the second group receive access to an additional emotional wellbeing module. The health promotion programme is available to use free of cost for a period of 12 weeks. At the start of the study and again after 12 weeks, participants in both groups complete a number of questionnaires to assess their mental wellbeing.

What are the possible benefits and risks of participating?
Participants may benefit from participation through improved health and emotional wellbeing and free access to the web-based programme. There are no known notable risks for participants wishing to take part.

Where is the study run from?
Abertawe Bro Morgannwg University Health Board (UK)

When is the study starting and how long is it expected to run for?
February 2017 to May 2017

Who is funding the study?
Health Care Research Wales (UK)

Who is the main contact?
Mrs Menna Brown
Menna.brown@swansea.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Menna Brown

ORCID ID

http://orcid.org/0000-0003-1427-1648

Contact details

Swansea Univerity
Medical School
Singleton campus
ILS2
Swansea
SA2 8PP
United Kingdom
+44 1792 606312
menna.brown@swansea.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HCRW: SCS-14-11

Study information

Scientific title

Champions for Health: a web-based wellbeing intervention to support physical health behaviour change: Protocol for a feasibility study

Acronym

Study hypothesis

The inclusion of an emotional wellbeing intervention within the champions programme will improve users (randomised to intervention arm) level of engagement with the physical health behaviour change modules and the platform overall.

Ethics approval

1. College of the Human and Health Sciences & College of Medicine Research Ethics Committee, Swansea University, 11/01/2017
2. ABMU Health Board Joint Study Review Committee (JSRC), 06/01/2017

Study design

Feasibility randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format please use contact details to request a partiicpant information sheet

Condition

Emotional wellbeing

Intervention

Randomisation procedure:
Participants are randomly allocated to a study arm after they complete the online registration process. A random sequence generator has been programmed into the registration process to ensure automated allocated to trial arms. The researchers are not involved in this allocation process and do not know who has been allocated to which study arm until the data is exported from the database at the end of the 12 weeks.

Study arm 1: Control
Those allocated to this study arm have access to the following five physical health modules (treatment): weight optimisation, physical activity, alcohol reduction, smoking cessation and five a day. Each module consists of information and advice on how to make healthy lifestyle changes (the resources were developed by public health wales). Participants have access to a personal user dashboard where they can record and monitor their progress over the duration of the 12 week trial. The modules are described as health challenges and participants are asked to select up to two modules to take part in.
The aim of each module is to provide healthy lifestyle information to the participants on how to make positive lifestyle improvements in their chosen health topic. Participants are encouraged to log onto the website weekly or as often as they wish to record their health behaviours. For example if a participant has selected the 'five a day' module, the user dashboard asks participants to record which fruits and vegetables they have consumed each day. This information is then displayed visually for them to track and monitor their progress over the 12 weeks.

Study arm 2: Intervention
In addition to the above, those allocated to the intervention arm also receive access to an emotional wellbeing intervention. The intervention consists of 12 weekly modules which will be released once per week in sequential order once the prior week has been opened. This intervention (treatment) is based on Acceptance and Commitment Therapy (ACT), it covers the six core components of ACT over the 12 weekly modules and includes activities to try out and PDF resources to download for continued use. Participants can record their mood over the 12 week period in the user dashboard alongside the physical health modules to view and monitor changes and progress over time.
Accompanying this intervention is the five ways to wellbeing textual information (provided by Public Health Wales) and information on sleep and relaxation.

At the start of the study and again after 12 weeks, participants in both groups complete a number of questionnaires to assess their mental wellbeing.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Emotional wellbeing, measured using the wellbeing score on the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) at baseline and 12 weeks

Secondary outcome measures

1. Health and wellbeing, measured using the Patient Health Questionnaire for Depression and Anxiety (PHQ-4) at baseline and 12 weeks
2. Psychological flexibility, measured using the Acceptance and Action Questionnaire—Revised (AAQ-II) at baseline and 12 weeks

Overall trial start date

04/01/2015

Overall trial end date

31/05/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Member of staff at selected health board
2. Aged 18 or above
3. Internet access
4. Ability to read written English
5. Ability to consent

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

100 in total, 50 in each arm

Participant exclusion criteria

1. Not a member of staff at selected health board
2. Not aged 18 or above
3. No Internet access
4. Inability to read written English
5. Inability to consent

Recruitment start date

12/01/2017

Recruitment end date

10/02/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Abertawe Bro Morgannwg University Health Board
One Talbot Gateway Baglan Energy Park Seaway Parade
Port Talbot
SA12 7BR
United Kingdom

Sponsor information

Organisation

Swansea University

Sponsor details

Swansea University
Singleton park
Swansea
SA2 8PP
United Kingdom
+44 1792 606060
reis@swansea.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Health and Care Research Wales

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publication in a high-impact peer reviewed journal by 2019.

IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Menna Brown (Menna.brown@swansea.ac.uk).

Intention to publish date

31/01/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes