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Lifestyle Matters
ISRCTN ISRCTN67209155
DOI 10.1186/ISRCTN67209155
ClinicalTrials.gov identifier
EudraCT number
Public title Lifestyle Matters
Scientific title Lifestyle Matters for maintenance of health and wellbeing
Acronym N/A
Serial number at source 11912
Study hypothesis 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.
Lay summary Lay summary under review 3
Ethics approval South Yorkshire Research Ethics Committee 07 March 2012, ref: 12/YH/0101
Study design Pragmatic two-arm parallel group randomised controlled trial, to determine the population benefit of an occupational therapy based intervention in people aged 65 years or older.
Countries of recruitment United Kingdom
Disease/condition/study domain All Diseases
Participants - 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
Participants - 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
Anticipated start date 01/12/2011
Anticipated end date 30/11/2015
Status of trial Ongoing
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants Planned Sample Size: 268; UK Sample Size: 268
Interventions 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.
Primary outcome measure(s) The SF-36 Mental Health (MH) dimension at 6 months post-randomisation
Secondary outcome measure(s) 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
Sources of funding Medical Research Council [MRC] (UK) - Lifelong Health and Wellbeing ref: G1001406/1
Trial website http://www.shef.ac.uk/lifestylematters
Publications 2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24053549
Contact name Mrs  Kirsty  Sprange
  Address University of Sheffield
School of Health and Related Research
Regents Court
30 Regent Street
  City/town Sheffield
  Zip/Postcode S1 4DA
  Country United Kingdom
  Tel +44 (0)114 222 2969
  Email k.sprange@sheffield.ac.uk
Sponsor University of Sheffield (UK)
  Address Health Services Research
School of Health & related Research (ScHARR)
Regents Court
30 Regent Street
  City/town Sheffield
  Zip/Postcode S1 4DA
  Country United Kingdom
  Tel +44 (0)114 222 2000
  Email
  Sponsor website: http://www.sheffield.ac.uk/
Date applied 22/03/2012
Last edited 25/09/2013
Date ISRCTN assigned 22/03/2012
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