An Evaluation of the Determinants of Lifestyle and Health Behaviors in Later Life (LiLL)

December 5, 2018 updated by: Sian Robinson, National Health Service, United Kingdom

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

86

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • MRC Lifecourse Epidemiology Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 110 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Users of the Medicine for Older People Services in Southampton

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical function
Time Frame: 2.5 years
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.
2.5 years
Grip strength
Time Frame: 2.5 years
Measuring using a Jamar dynamometer
2.5 years
Timed up and go
Time Frame: 2.5 years
Time taken to rise from a chair, walk 3m and then return to the chair and sit down.
2.5 years
3m walk
Time Frame: 2.5 years
Time taken to walk 3m
2.5 years
Timed chair rise
Time Frame: 2.5 years
Time taken to stand up and sit down again five times
2.5 years
Mortality
Time Frame: At 1 year and 2.5 years follow up
Mortality data will be taken from hospital records
At 1 year and 2.5 years follow up
Number of hospital admissions
Time Frame: At one year follow up
Number of hospital admissions will be abstracted from hospital records
At one year follow up
New diagnoses
Time Frame: At one year follow up
New diagnoses will be taken from hospital records
At one year follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sian Robinson, PhD, National Health Service, United Kingdom

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2015

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

December 1, 2018

Study Registration Dates

First Submitted

September 24, 2015

First Submitted That Met QC Criteria

October 9, 2015

First Posted (ESTIMATE)

October 12, 2015

Study Record Updates

Last Update Posted (ACTUAL)

December 6, 2018

Last Update Submitted That Met QC Criteria

December 5, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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