Condition category
Not Applicable
Date applied
06/11/2015
Date assigned
17/11/2015
Last edited
16/11/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Being physically active has numerous benefits for our health and well-being. However, levels of physical activity decline as we age. The majority of older adults do not meet current recommended levels of physical activity. Research also suggests that those who live in socially/economically deprived areas are among the most inactive. Therefore, increasing physical activity levels in this population is an important public health issue. Using active peers who are a similar age and background may be an effective way to increase levels of physical activity among inactive older adults (defined in this study as those aged 60-70 years). This study aims to test the acceptability and preferences of a sample of older adults to a peer-led walking programme.

Who can participate?
Men and women aged 60 – 70 who are not currently physically active and live in a socio-economically disadvantaged community in the South Eastern Trust.

What does the study involve?
Participants are randomly allocated to one of two groups: the intervention group or the control group. The intervention group participates in the ‘Walk With Me’ intervention, where they are encouraged by their peer mentor to increase their physical activity. Participants set goals and use pedometers to monitor their physical activity, and after 12 weeks they are signposted to other activity programmes in the community to encourage them to maintain their activity level. The control group do not receive any additional support to change their activity over the course of the study, apart from a brief booklet on physical activity (this is also given to the intervention group), and after the end of the study they will be offered opportunities to engage in physical activity. We are interested in the opinions of both the peer mentors and participants regarding what worked and what could be improved about the intervention, so we are conducting a number of interviews and focus groups to collect this information.

What are the possible benefits and risks of participating?
Regular participation in physical activity has numerous benefits for health and wellbeing. It is hoped that this intervention will encourage participants to perform more moderate intensity physical activity, of which walking will be the main form. This is a low risk intervention and we do not anticipate any serious adverse events.

Where is the study run from?
Queen's University Belfast (UK).

When is the study starting and how long is it expected to run for?
December 2014 to March 2018.

Who is funding the study?
National Institute for Health Research (UK).

Who is the main contact?
Dr Conor Cunningham (c.cunningham@qub.ac.uk)
Dr Mark Tully (m.tully@qub.ac.uk)

Trial website

Contact information

Type

Public

Primary contact

Dr Conor Cunningham

ORCID ID

Contact details

Queen's University Belfast
Institute of Clinical Science B
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BJ
United Kingdom
+44 (0)28 9063 2219
c.cunningham@qub.ac.uk

Type

Scientific

Additional contact

Dr Mark Tully

ORCID ID

http://orcid.org/0000-0001-9710-4014

Contact details

Queen's University Belfast
Institute of Clinical Science B
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BJ
United Kingdom
+44 (0)28 9063 2721
m.tully@qub.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PHR - 12/133/04

Study information

Scientific title

A feasibility study and pilot randomised controlled trial of a peer-led walking programme to increase physical activity in inactive older adults: Walk With Me Study

Acronym

Study hypothesis

To determine the feasibility of the "Walk With Me" peer-led walking intervention in socio-economically disadvantaged community dwelling older adults

Ethics approval

The Office of Research Networks Northern Ireland, December 2014, REC ref: 14/NI/1330

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Physical activity

Intervention

The intervention group
The ‘Walk With Me’ intervention is a peer led 12-week walking programme in community dwelling older adults.

During the intervention period the participant will have regular contact with the peer mentor, and be encouraged to increase their time spent in moderate intensity physical activity. Six peer mentors will be recruited. They will be paired with participants of the same sex and from a similar community. During the pilot RCT, peer mentors will be given access to a research team member for advice/support and will be contacted by the project manager at least once per fortnight, to identify any problems with the programme delivery or participant contact and engagement.

The intervention will begin with a first face-to-face meeting between the peer mentor and participant. The programme will then involve a phased approach, with an initial period of trust building, identifying current levels of physical activity and facilitators and barriers to increasing activity, and identifying strategies to overcome these barriers and increase activity (e.g. discussing opportunities in the local environment). This is followed by individually-tailored goal setting, where weekly targets are discussed, agreed and reviewed. This will be done using pedometers to set individually tailored goals and self-monitor progress using weekly step diaries, as in previous peer-led physical activity interventions.

After 12 weeks, the formal peer-led component will finish, and participants in the intervention group will be signposted to other activity programmes in the community to encourage maintenance of their activity level.

The control group
The control group will participate in baseline and 6-month follow-up data collection activities. Those assigned to the control group will not receive any additional support to change their activity over the course of the intervention period. At the outset of the trial, they will receive a brief health promotion booklet on physical activity (the same booklet will be given to the intervention group) and will be informed that after the 6-month data collection point, they will be offered a choice of opportunities to engage in physical activity.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Minutes of moderate and vigorous physical activity (MVPA) objectively measured using an Actigraph GT3-X accelerometer (physical activity monitor) over 7 days. Outcomes will be measured at baseline, post-intervention (12 weeks) and 6 months after baseline.

Secondary outcome measures

1. A validated self-reported physical activity questionnaire (EPAQ-2)
2. Physical and mental health measured using the SF-12
3. Mental wellbeing measured using the Warwick-Edinburgh Mental Well-being Scale
4. Health-related quality of life assessed using EuroQol-5D
5. Social engagement measured with the UCLA Loneliness Scale and the Lubben Social Network Scale
Outcomes will be measured at baseline, post-intervention (12 weeks) and 6 months after baseline.

Overall trial start date

01/12/2014

Overall trial end date

01/03/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female aged 60 – 70 years
2. Living in a socio-economically disadvantaged community in the South Eastern Trust (defined as the lowest quartile of super output areas according to the Northern Ireland Multiple Deprivation Measure)
3. Competent to give informed consent
4. Not currently physically active (assessed using the General Practice Physical Activity Questionnaire)
5. Community dwelling (i.e., living in their own home)
6. Planning to stay in the current residence during the next year
7. Able to communicate in English

Participant type

Other

Age group

Mixed

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Not aged 60 – 70 years
2. Not living in a socio-economically disadvantaged community in the South Eastern Trust (defined as the lowest quartile of super output areas according to the Northern Ireland Multiple Deprivation Measure)
3. Not competent to give informed consent
4. Currently physically active (assessed using the General Practice Physical Activity Questionnaire)
5. Not community dwelling (i.e., living in a residential home or care facility)
6. Not planning to stay in the current residence during the next year
7. Not able to communicate in English

Recruitment start date

01/12/2015

Recruitment end date

31/03/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Public Health
Queen's University Belfast Institute of Clinical Science B Royal Victoria Hospital Grosvenor Road
Belfast
BT12 6BJ
United Kingdom

Sponsor information

Organisation

South Eastern Health and Social Care Trust (SEHSCT) (UK)

Sponsor details

Research and Development office
Room 19
Home 3
Ulster Hospital
Dundonald
Belfast
BT16 1RH
United Kingdom

Sponsor type

Research organisation

Website

Organisation

Queen's University (UK)

Sponsor details

63 University Road
Belfast
BT7 1NF
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes