Mental Health Wellness 1NCT03054311
Lifestyle Matters: An Occupational Approach Towards Health and Well-being in Later Life
A study testing Lifestyle Matters in people with Mental Health Wellness 1, run by University of Sheffield at 1 site in United Kingdom.
Trial summary
Lifestyle Matters is an occupational approach to healthy ageing, which helps older people to get the most out of life. The intervention is based on an American model of health promotion called Lifestyle Redesign. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- Lifestyle Matters
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2004to Jul 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Community living
- Aged 65 or over
Who cannot join
- Score of 18 or under on Mini-Mental State Examination (MMSE)
- high level of depression, assessed using the Geriatric depression rating scale (GDS)
Trial locations and contacts
1 site in 1 country.
About this study
Lifestyle Matters is an occupational approach to healthy ageing, which helps older people to get the most out of life. The intervention is based on an American model of health promotion called Lifestyle Redesign. This was found to be highly effective in enhancing the physical and mental health, occupational functioning and life satisfaction of community living older adults in Los Angeles, USA.
Weekly group meetings provide older people with the space, time and opportunity to share their experiences. Through a process of peer exchange and guidance, participants have the opportunity to reflect upon the range of activities that they engage with. They are then helped to begin to understand how these activities might impact on their health and well-being. However this approach alone cannot meet the complex needs of individual older people, and their specific and personal concerns. In recognition of this, the programme also includes monthly individual sessions with one of the group facilitators. The older person in partnership with the facilitator identifies a tailored programme to meet their individual needs, including the means by which they might work towards their personal goals. The individual programme is updated and refreshed in subsequent meetings over the months.
During 2004/5 researchers at Sheffield Hallam University in partnership with other researchers in York and Leeds, and clinical colleagues in Sheffield explored the feasibility of delivering this intervention to older people living in the UK. The project was funded through the Sheffield Health and Social Research Consortium. The summary below is an account of the process and outcomes of delivering a Lifestyle Matters programme to two groups of community living older people during 2004/5.
- Conditions
- Mental Health Wellness 1
- Being tested
- Lifestyle Matters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle MattersBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Matters intervention | Experimental | Not described Receives: Behavioral: Lifestyle Matters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Mental State examination
Measured: On average 8 months after commencing intervention
Secondary outcomes (5)
Geriatric Depression Rating Scale
Measured: On average 8 months after commencing intervention
Barthel Index
Measured: On average 8 months after commencing intervention
SF36 Quality of Life
Measured: On average 8 months after commencing intervention
WHODAS (World Health Disability Assessment Schedule)
Measured: On average 8 months after commencing intervention
Nottingham Leisure Questionnaire
Measured: On average 8 months after commencing intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study startJan 2004
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Gail Mountain, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054311
- Sponsor's protocol ID
- 2006/01/GM
- Status last verified
- Feb 2017
- First submitted
- 19 Jan 2017
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mountain GA, Craig CL. The lived experience of redesigning lifestyle post-retirement in the UK. Occup Ther Int. 2011 Mar;18(1):48-58. doi: 10.1002/oti.309. Epub 2010 Dec 9.
PubMed 21341343Chatters R, Newbould L, Sprange K, Hind D, Mountain G, Shortland K, Powell L, Gossage-Worrall R, Chater T, Keetharuth A, Lee E, Woods B. Recruitment of older adults to three preventative lifestyle improvement studies. Trials. 2018 Feb 20;19(1):121. doi: 10.1186/s13063-018-2482-1.
PubMed 29458392
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Matters: An Occupational Approach Towards Health and Well-being in Later Life
- ClinicalTrials.gov ID
- NCT03054311
- Acronym / sponsor ID
- 2006/01/GM
- Conditions
- Mental Health Wellness 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 15 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lifestyle Matters is an occupational approach to healthy ageing, which helps older people to get the most out of life. The intervention is based on an American model of health promotion called Lifestyle Redesign. This was found to be highly effective in enhancing the physical and mental health, occupational functioning and life satisfaction of community living older adults in Los Angeles, USA.
Weekly group meetings provide older people with the space, time and opportunity to share their experiences. Through a process of peer exchange and guidance, participants have the opportunity to reflect upon the range of activities that they engage with. They are then helped to begin to understand how these activities might impact on their health and well-being. However this approach alone cannot meet the complex needs of individual older people, and their specific and personal concerns. In recognition of this, the programme also includes monthly individual sessions with one of the group facilitators. The older person in partnership with the facilitator identifies a tailored programme to meet their individual needs, including the means by which they might work towards their personal goals. The individual programme is updated and refreshed in subsequent meetings over the months.
During 2004/5 researchers at Sheffield Hallam University in partnership with other researchers in York and Leeds, and clinical colleagues in Sheffield explored the feasibility of delivering this intervention to older people living in the UK. The project was funded through the Sheffield Health and Social Research Consortium. The summary below is an account of the process and outcomes of delivering a Lifestyle Matters programme to two groups of community living older people during 2004/5.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Matters intervention | Experimental | Behavioral: Lifestyle Matters |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Community living
- Aged 65 or over
Key exclusion criteria (2 listed)
- Score of 18 or under on Mini-Mental State Examination (MMSE)
- high level of depression, assessed using the Geriatric depression rating scale (GDS)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle Matters | Behavioural | Lifestyle Matters intervention |
Primary outcome
Mini Mental State examination
Time frame: On average 8 months after commencing intervention
5 secondary outcomes
Geriatric Depression Rating Scale
Time frame: On average 8 months after commencing intervention
Barthel Index
Time frame: On average 8 months after commencing intervention
SF36 Quality of Life
Time frame: On average 8 months after commencing intervention
WHODAS (World Health Disability Assessment Schedule)
Time frame: On average 8 months after commencing intervention
Nottingham Leisure Questionnaire
Time frame: On average 8 months after commencing intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- Background: PubMed 21341343Mountain GA, Craig CL. The lived experience of redesigning lifestyle post-retirement in the UK. Occup Ther Int. 2011 Mar;18(1):48-58. doi: 10.1002/oti.309. Epub 2010 Dec 9.
- Derived from this study: PubMed 29458392Chatters R, Newbould L, Sprange K, Hind D, Mountain G, Shortland K, Powell L, Gossage-Worrall R, Chater T, Keetharuth A, Lee E, Woods B. Recruitment of older adults to three preventative lifestyle improvement studies. Trials. 2018 Feb 20;19(1):121. doi: 10.1186/s13063-018-2482-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Matters in people with Mental Health Wellness 1, run by University of Sheffield at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini Mental State examination (time frame: On average 8 months after commencing intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03054311, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2017.