AgingLiLLNCT02574416
An Evaluation of the Determinants of Lifestyle and Health Behaviors in Later Life
An observational study of Aging and Dietary Habits, run by National Health Service, United Kingdom at 1 site in United Kingdom.
Trial summary
Although increasing age is associated with declining health and function, there are wide variations between individuals in the ageing process. Some of these differences are explained by differences in lifestyle, but little is known about the determinants of lifestyle in older age. Read more about this study
- Who is it for?
- Ages 60 to 110 years
- Conditions the study is for
- Aging, Dietary Habits, Life Style
- How many people
- 86 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2015to Dec 2018
- Phase
- Observational
- 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 60 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Users of the Medicine for Older People Services in Southampton
Who may be able to join
- Any person who has attended a Medicine for Older People Service run by Southampton General Hospital between February 2014 and August 2016.
Who cannot join
- Unable to give informed consent
- acutely unwell
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
MRC Lifecourse Epidemiology Unit
Southampton, Hampshire, SO16 6YD
About this study
Official title: An Evaluation of the Determinants of Lifestyle and Health Behaviours in Later Life, and to Investigate Their Relationship With Health Outcomes
Although increasing age is associated with declining health and function, there are wide variations between individuals in the ageing process. Some of these differences are explained by differences in lifestyle, but little is known about the determinants of lifestyle in older age. The proposed project will describe influences on health behaviour and lifestyle in older adults. Investigators will undertake a prospective study of community-dwelling older people who use any of the Medicine for Older People Services in Southampton, allowing us to gain obtain important insights into the relationship between health behaviour, lifestyle and health outcomes in older people. Our principal aim is to identify key points on the ageing pathway when interventions may be best targeted to promote health. The findings of this project will underpin the design for a complex intervention to be conducted in the future to improve the health outcomes of older people.
Read the detailed description
Patients will be identified by the Medicine for Older People clinician and asked if they would like to speak to a member of the research team. A member of the research team will approach suitable patients and ask them if they wish to participate. Patients will have the opportunity to read and take away a Patient Information Sheet, and also ask questions about the study and what participating in it would involve. Participants in the study will be telephoned to arrange an appointment for a home visit at a convenient time, or an appointment will be made at this first meeting if this is possible. Written informed consent will be taken at the home visit.
Patients who have used the same Medicine for Older People Services in Southampton within the previous year will be known to the medical team. The medical team will write to the patient with a letter of invitation to participate in the study and the Patient Information Sheet. The letter will contain a reply slip and a stamped addressed envelope. It will also contain contact details should the patient wish to talk to someone about the study and what it would mean for them to participate. Patients who send back their reply slip saying that they would like to participate in the study will be contacted to arrange a home visit at a convenient time. If no reply slip is received after two weeks then a member of the research team will telephone the patient once to find out whether they have received the letter and to offer them the opportunity to participate. This will be done sensitively and carefully and the patients' wishes will be respected at all times. Written informed consent will be taken at the time of the home visit.
All participants will be visited at home by a member of the research team who will interview the participant to obtain background sociodemographic information and a series of short questionnaires will be administered. Each participant will have an assessment of diet quality, appetite and physical function. In addition, weight, grip strength and physical performance will be measured. Participants will be free to decline any part of the questionnaire or assessment.
Two and a half years after this interview the investigators will check on the hospital administration system if the participant's contact details have changed or if they have died since the initial visit. The investigators will then contact the participant by phone (having gained permission to do this at the original assessment visit) to arrange a home visit when diet quality, appetite and physical function will be reassessed. The investigators' experience from the Southampton Mealtime Assistance Study of contacting older study participants by telephone has shown this to be an effective way of ascertaining if the participant is interested in continuing with the study or would prefer not to. The participant will be given the opportunity to refuse a visit with no pressure applied. At the visit the investigators will also ask about the participants' use of the key community services over the past year. The investigators will also ask permission to access the patient's medical records to obtain details of hospital admissions or outpatient appointments in the intervening year.
- Conditions
- Aging, Dietary Habits, Life Style
- Being tested
- There is no intervention
- Keywords
- Health behaviour, Health outcomes, Diet quality, Physical function, Lifestyle, Older adults
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no interventionOther
The study is observational and there is no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary quality
Diet quality, which will be assessed by deriving the participants' prudent diet score from the 20-item Food Frequency Questionnaire.
Measured: 2.5 years
Secondary outcomes (8)
Physical function
Physical function which will be assessed by asking ten questions from the Short Form - 36 which ask whether the participants' health limits them from carrying out certain daily activities.
Measured: 2.5 years
Grip strength
Measuring using a Jamar dynamometer
Measured: 2.5 years
Timed up and go
Time taken to rise from a chair, walk 3m and then return to the chair and sit down.
Measured: 2.5 years
3m walk
Time taken to walk 3m
Measured: 2.5 years
Timed chair rise
Time taken to stand up and sit down again five times
Measured: 2.5 years
Mortality
Mortality data will be taken from hospital records
Measured: At 1 year and 2.5 years follow up
Number of hospital admissions
Number of hospital admissions will be abstracted from hospital records
Measured: At one year follow up
New diagnoses
New diagnoses will be taken from hospital records
Measured: At one year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2016
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Service, United Kingdom
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sian Robinson, National Health Service, United Kingdom
- Investigators
- Sian Robinson, PhD, Principal investigator, National Health Service, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574416
- Sponsor's protocol ID
- RHM MED 1215
- Acronym
- LiLL
- Status last verified
- Dec 2018
- First submitted
- 24 Sep 2015
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Determinants of Lifestyle and Health Behaviours in Later Life, and to Investigate Their Relationship With Health Outcomes
- ClinicalTrials.gov ID
- NCT02574416
- Acronym / sponsor ID
- LiLL / RHM MED 1215
- Conditions
- Aging, Dietary Habits, Life Style
- Keywords
- Health behaviour, Health outcomes, Diet quality, Physical function, Lifestyle, Older adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- National Health Service, United KingdomOther government
- Study start
- Feb 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 12 Oct 2015 (estimated)
- 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.
Although increasing age is associated with declining health and function, there are wide variations between individuals in the ageing process. Some of these differences are explained by differences in lifestyle, but little is known about the determinants of lifestyle in older age. The proposed project will describe influences on health behaviour and lifestyle in older adults. Investigators will undertake a prospective study of community-dwelling older people who use any of the Medicine for Older People Services in Southampton, allowing us to gain obtain important insights into the relationship between health behaviour, lifestyle and health outcomes in older people. Our principal aim is to identify key points on the ageing pathway when interventions may be best targeted to promote health. The findings of this project will underpin the design for a complex intervention to be conducted in the future to improve the health outcomes of older people.
Detailed description
Patients will be identified by the Medicine for Older People clinician and asked if they would like to speak to a member of the research team. A member of the research team will approach suitable patients and ask them if they wish to participate. Patients will have the opportunity to read and take away a Patient Information Sheet, and also ask questions about the study and what participating in it would involve. Participants in the study will be telephoned to arrange an appointment for a home visit at a convenient time, or an appointment will be made at this first meeting if this is possible. Written informed consent will be taken at the home visit.
Patients who have used the same Medicine for Older People Services in Southampton within the previous year will be known to the medical team. The medical team will write to the patient with a letter of invitation to participate in the study and the Patient Information Sheet. The letter will contain a reply slip and a stamped addressed envelope. It will also contain contact details should the patient wish to talk to someone about the study and what it would mean for them to participate. Patients who send back their reply slip saying that they would like to participate in the study will be contacted to arrange a home visit at a convenient time. If no reply slip is received after two weeks then a member of the research team will telephone the patient once to find out whether they have received the letter and to offer them the opportunity to participate. This will be done sensitively and carefully and the patients' wishes will be respected at all times. Written informed consent will be taken at the time of the home visit.
All participants will be visited at home by a member of the research team who will interview the participant to obtain background sociodemographic information and a series of short questionnaires will be administered. Each participant will have an assessment of diet quality, appetite and physical function. In addition, weight, grip strength and physical performance will be measured. Participants will be free to decline any part of the questionnaire or assessment.
Two and a half years after this interview the investigators will check on the hospital administration system if the participant's contact details have changed or if they have died since the initial visit. The investigators will then contact the participant by phone (having gained permission to do this at the original assessment visit) to arrange a home visit when diet quality, appetite and physical function will be reassessed. The investigators' experience from the Southampton Mealtime Assistance Study of contacting older study participants by telephone has shown this to be an effective way of ascertaining if the participant is interested in continuing with the study or would prefer not to. The participant will be given the opportunity to refuse a visit with no pressure applied. At the visit the investigators will also ask about the participants' use of the key community services over the past year. The investigators will also ask permission to access the patient's medical records to obtain details of hospital admissions or outpatient appointments in the intervening year.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 60 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Users of the Medicine for Older People Services in Southampton
Key inclusion criteria (1 listed)
- Any person who has attended a Medicine for Older People Service run by Southampton General Hospital between February 2014 and August 2016.
Key exclusion criteria (2 listed)
- Unable to give informed consent
- acutely unwell
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 |
|---|---|---|
| There is no interventionThe study is observational and there is no intervention | Other | – |
Primary outcome
Dietary quality
Time frame: 2.5 years
Diet quality, which will be assessed by deriving the participants' prudent diet score from the 20-item Food Frequency Questionnaire.
8 secondary outcomes
Physical function
Time frame: 2.5 years
Grip strength
Time frame: 2.5 years
Timed up and go
Time frame: 2.5 years
3m walk
Time frame: 2.5 years
Timed chair rise
Time frame: 2.5 years
Mortality
Time frame: At 1 year and 2.5 years follow up
Number of hospital admissions
Time frame: At one year follow up
New diagnoses
Time frame: At one year follow up
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 6 Dec 2018.
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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.
Sian Robinson, PhD principal investigator
National Health Service, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Dietary Habits, run by National Health Service, United Kingdom 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 1 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 6 Dec 2018. 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?
Dietary quality (time frame: 2.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2018.