Clinical trial NCT02574416: An Evaluation of the Determinants of Lifestyle and Health Behaviors in Later Life
Official title: An Evaluation of the Determinants of Lifestyle and Health Behaviours in Later Life, and to Investigate Their Relationship With Health Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aging
Dietary Habits
Life Style
Keywords: Health behaviour
Health outcomes
Diet quality
Physical function
Lifestyle
Older adults
Lead sponsor: National Health Service, United Kingdom
Sponsor class: OTHER_GOV
First posted: 2015-10-12
Enrollment: 86
Sex: ALL
Minimum age (years): 60
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Users of the Medicine for Older People Services in Southampton

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Any person who has attended a Medicine for Older People Service run by Southampton General Hospital between February 2014 and August 2016.

Exclusion Criteria:

* Unable to give informed consent
* acutely unwell

Primary outcomes:
measure: Dietary quality
timeFrame: 2.5 years
Secondary outcomes:
measure: Physical function
timeFrame: 2.5 years
measure: Grip strength
timeFrame: 2.5 years
measure: Timed up and go
timeFrame: 2.5 years
measure: 3m walk
timeFrame: 2.5 years
measure: Timed chair rise
timeFrame: 2.5 years
measure: Mortality
timeFrame: At 1 year and 2.5 years follow up
measure: Number of hospital admissions
timeFrame: At one year follow up
measure: New diagnoses
timeFrame: At one year follow up
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: MRC Lifecourse Epidemiology Unit
state: Hampshire
Study officials:
affiliation: National Health Service, United Kingdom
name: Sian Robinson, PhD
role: PRINCIPAL_INVESTIGATOR
References: