Lifestyle Matters
| ISRCTN | ISRCTN67209155 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67209155 |
| Secondary identifying numbers | 11912 |
- Submission date
- 22/03/2012
- Registration date
- 22/03/2012
- Last edited
- 02/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
In later life, mental wellbeing can be improved through taking part in meaningful activities and occupations as part of everyday life. This study will evaluate whether a group activity programme called Lifestyle Matters can help improve and sustain physical and mental wellbeing in people aged 65 and older.
Who can participate?
People aged 65 and over who are living independently in Sheffield and North Wales.
What does the study involve?
Participants are randomly allocated to one of two groups. One group continues with their usual care, accessing health and social care services as appropriate to meet their needs. Participants in the other group attend 16 weekly meetings at a local community venue and are also offered monthly one-to-one sessions where they are encouraged to pursue personal goals. All participants are assessed at the start of the study and again 6 and 24 months later. A small number of participants are interviewed at the end of the programme to evaluate the impact of the Lifestyle Matters programme upon their health and wellbeing.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
University of Sheffield (UK)
When is the study starting and how long is it expected to run for?
December 2011 to November 2015
Who is funding the study?
Medical Research Council (UK)
Who is the main contact?
Kirsty Sprange
k.sprange@sheffield.ac.uk
Contact information
Scientific
University of Sheffield
School of Health and Related Research
Regents Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
| Phone | +44 (0)114 222 2969 |
|---|---|
| k.sprange@sheffield.ac.uk |
Study information
| Study design | Pragmatic two-arm parallel-group randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Lifestyle Matters for maintenance of health and wellbeing |
| Study objectives | To ascertain whether taking part in an occupational therapy based lifestyle intervention, Lifestyle Matters, can improve mental wellbeing, self efficacy and resilience in people aged 65 years and over. The aims of this research are to: 1. Evaluate (through a randomised controlled trial) the clinical and cost effectiveness of a psycho-social intervention to promote healthy ageing (Lifestyle Matters). 2. Examine the underlying mechanisms that can promote self efficacy and resilience. 3. Determine the long term sustainability of the intervention. |
| Ethics approval(s) | South Yorkshire Research Ethics Committee, 07/03/2012, ref: 12/YH/0101 |
| Health condition(s) or problem(s) studied | All Diseases |
| Intervention | 268 participants will be randomly allocated to one of two groups. 134 participants allocated to the intervention group will receive an occupational therapy based lifestyle intervention called 'Lifestyle Matters'. Groups of 10-12 participants attend 16 weekly facilitated activity based meetings at a local community venue and in the community. The groups are assisted by trained facilitators to enable participants to select, explore and engage with activities that are relevant to them. Didactic sessions relevant to the needs of specific members are also woven into the programme to enhance participants' knowledge of how to overcome barriers to active engagement. Each participant will also be offered monthly 1-1 sessions with the facilitators where they are encouraged to pursue personal goals. The 134 participants allocated to the control group will continue with usual care. Usual care being defined as accessing health and social care acute and community services as appropriate to meet needs. |
| Intervention type | Behavioural |
| Primary outcome measure | The SF-36 Mental Health (MH) dimension at 6 months post-randomisation |
| Secondary outcome measures | 1. SF-36 Mental Health (MH) dimension at 24 months post-randomisation 2. Other dimensions of the SF-36 at 6 and 24 months post-randomisation 3. PHQ-9 at 6 and 24 months post-randomisation 4. EQ-5D at 6 and 24 months post-randomisation 5. General Perceived Self-Efficacy Scale (GSE) at 6 and 24 months post-randomisation 6. de Jong Gierveld loneliness scale at 6 and 24 months post-randomisation 7. ONS Wellbeing Question from the Integrated Household Survey 2011 at 6 and 24 months post-randomisation 8. Brief Resilience Scale at 6 and 24 months post-randomisation 9. A health and social care resource use questionnaire to collect participants' use of health, social care and community services for health economic analysis |
| Overall study start date | 01/12/2011 |
| Completion date | 30/11/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | Planned Sample Size: 268; UK Sample Size: 268 |
| Key inclusion criteria | 1. Aged 65 years or older 2. Display reasonable congitive function as measured by a score of 07 on the Six Item Cognitive Impairement Test (6CIT) 3. Living independently or in sheltered accommodation, alone or with others 4. Are able to converse in English or Welsh |
| Key exclusion criteria | 1. Aged 64 years and under 2. Score of 8 or more on the Six Item Cognitive Impairement Test (6CIT) 3. Living in residential/nursing home accommodation 4. Unable to converse in English or Welsh |
| Date of first enrolment | 01/08/2012 |
| Date of final enrolment | 19/04/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
S1 4DA
United Kingdom
Sponsor information
University/education
Health Services Research
School of Health & related Research (ScHARR)
Regents Court
30 Regent Street
Sheffield
S1 4DA
England
United Kingdom
| Phone | +44 (0)114 222 2000 |
|---|---|
| abc@email.com | |
| Website | http://www.sheffield.ac.uk/ |
"ROR" |
https://ror.org/05krs5044 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 21/09/2013 | Yes | No | |
| Results article | results | 01/07/2017 | Yes | No | |
| Results article | long-term results | 24/09/2017 | Yes | No |
Editorial Notes
02/10/2017: Publication reference added.
27/03/2017: Publication reference added.
02/06/2016: The recruitment dates have been updated from 01/12/2011 - 30/11/2015 to 01/08/2012 - 19/04/2013.
