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Lifestyle Interventions at Retirement

Pilot Randomised Controlled Trial of an Internet-based Lifestyle Intervention for People Around Retirement

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02136381
Enrollment
90
Registered
2014-05-13
Start date
2014-05-31
Completion date
2015-02-28
Last updated
2014-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Behavior

Keywords

Lifestyle, interventions, retirement

Brief summary

The LiveWell research programme aims to develop evidence-based, acceptable and scalable interventions to improve health and wellbeing in the retirement transition. Life stage transitions involve changes in lifestyle and thus present key opportunities for behaviour change interventions. Our assessment of the literature shows that interventions with people of retirement age can effectively promote components of the Mediterranean diet (Lara et al, BMC Medicine Apr 8;12(1):60: 2014), physical activity (Hobbs et al, BMC Medicine Mar 19;11:75; 2013) and explicit social roles (Heaven et al, Milbank Q. Jun;91(2):222-87: 2013). This study is a 2-month randomised controlled trial (RCT) with two intervention arms taking place in the North-East of England. We have developed an internet-based lifestyle programme (Living, Eating, Activity and Planning through retirement (LEAP)) that promotes three key health and social behaviours; 1) healthy eating by adopting a Mediterranean diet, 2) increasing physical activity with the use of a step-counter, and 3) improving social connectedness. Participants recruited for this study will be allocated in random order with a ratio of 2:1 to the intervention group (LEAP) or to a control group. This study will evaluate the feasibility and acceptability of the LEAP intervention among people of retirement age and will pilot trial procedures. In this programme of research we have also defined a suite of outcome measures and identified tools appropriate for capturing the Healthy Ageing Phenotype (HAP) (Lara et al, Maturitas. 2013 Oct;76(2):189-99). We will assess aspects of Cognition, Physical capability, Physiological outcomes, and psycho-social wellbeing. The feasibility and acceptability of these measures has yet to be determined and therefore will be formally assessed in this pilot RCT alongside more proximal outcomes of the intervention modules (i.e. diet, physical activity and social roles). The hypotheses to be tested in the LiveWell programme are as follows: * A newly developed internet-based lifestyle programme (Living, Eating, Activity and Planning through retirement (LEAP)) is an acceptable tool for behaviour change among people of peri-retirement age. * A suite of outcome measures and identified tools appropriate for capturing the Healthy Ageing Phenotype (HAP) is acceptable among people of peri-retirement age.

Detailed description

This intervention will last two months. Participants will attend a 2-hour session with the researchers in order to provide signed consent and undergo the baseline assessment of healthy-ageing related outcome measures. Participants will attend a second 2-hour session after two months to repeat the assessment. The assessments will take place at the participant's place of work. Participants who have retired will be asked to attend assessments at their previous place of work, at a local privately hired venue (e.g. community hall), or in their own homes. Semi-structured interviews (n=28) will be conducted with a sample of participants from the intervention and control groups and two 'reduced participation' groups. The reduced participation groups will include people who decline to participate in the trial but consent to a brief qualitative interview about their decision not to participate (after initially expressing interest) (n= up to 2), and people who withdraw from the trial but consent to a follow-up interview (n= up to 2). The interviews will address three overlapping domains of enquiry: 1) questions relating to participation in the pilot study; 2) questions relating to use of the intervention website; and 3) questions relating to the use of the HAP set of measurement tools.

Interventions

BEHAVIORALLEAP intervention

LEAP has 5 modules of tools and resources. LEAP is personalised based on information provided at different stages. The user determines the modules to complete (skipping or revisiting modules). Users can choose among 8 animated mentors (4 female; 4 male) to guide them through the intervention. Users will provide demographic data, health-related information, and current lifestyles in order to tailor the advice to be received. Advice will focus on adopting elements of a Mediterranean dietary pattern, increase physical activity, and improve social connectedness. Participants will receive 1) Mediterranean diet recipes; 2) a step counter to monitor physical activity goals; 3) advice in how to enhance social engagement and facilitate social roles

BEHAVIORALControl

Thirty participants will be randomised to a minimal intervention comparator condition, where participants will be emailed a direct link to the National Health Service (NHS) choices 'LiveWell' website (http://www.nhs.uk/LiveWell/Pages/Livewellhub.aspx). The email will encourage the participants to access the health resources and information on the pages labelled men's health 40-60, men's health 60-plus, women's health 40-60, women's health 60-plus, as appropriate. Participants in the control group will be assessment after two months.

Sponsors

Newcastle University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
55 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Adults within 2 years (before/after) retirement from full time work * Healthy volunteers * Internet users * English language speakers

Exclusion criteria

* Non-internet users * Non-English speakers * Not within the peri-retirement period (within two years of retirement)

Design outcomes

Primary

MeasureTime frameDescription
Feasibility and acceptability of intervention2 monthsParticipants will complete a questionnaire directed to obtain early markers of how the intervention is used

Secondary

MeasureTime frameDescription
Change from baseline physical activity levels at 2 months0 and 2 monthsPhysical activity will be assessed assessed during seven days at baseline and after 2 months interventions by accelerometry.
Change from baseline dietary intake0 and 2 monthsParticipants will self-report dietary intake using the 24-hour dietary recall method. Three days (including 2 weekdays and 1 weekend day) of dietary intake at baseline and after two months will be reported.
Change from baseline resting blood pressure at 2 months0 and 2 months
Change from baseline lung function at 2 months0 and 2 monthsLung function will be measured by spirometry (a breathing test measuring how much air someone can breathe in and out. It also measures how fast you can blow air out)
Change from baseline dexterity at 2 months0 and 2 monthsThe National Institutes of Health Toolbox dexterity test, involving the 9-hole pegboard test (measuring the ability to coordinate fingers to manipulate objects quickly and accurately), will be used.
Change from baseline Handgrip strength at 2 months0 and 2 months
Change from baseline walking speed at 2 months0 and 2 monthsWalking speed will be measured by walking 4 meters at a normal pace
Change from baseline endurance at 2 months0 and 2 monthsEndurance will be measured as the total distance walked at a fast pace during 2 minutes
Change from baseline standing balance at 2 months0 and 2 months
Change from baseline functional change of transitional movements at 2 months0 and 2 monthsThe sit-to-stand test will be used
Change from baseline mobility at 2 months0 and 2 monthsThe timed-up-and-go test will be used
Change from baseline episodic memory at 2 months0 and 2 monthsThe Paired Associates Learning (PAL) episodic memory test will be used
Change from baseline verbal and category fluency at 2 months0 and 2 monthsThe verbal and category fluency test will be used
Functional outcomesAt 0 and 2 monthsAt baseline and at 2 months post-randomisation, participants will be asked to complete a series of tests to assess the impact of the programme on the following health-related indices: 1. Resting blood pressure 2. Lung function by spirometry (a breathing test measuring how much air someone can breathe in and out. It also measures how fast you can blow air out) 3. Dexterity test (measuring the ability to coordinate fingers to manipulate objects quickly and accurately) 4. Handgrip strength (a measure of muscle strength) 5. Walking speed (measured by walking 4 meters at a normal pace) 6. Endurance (measured by walking at a fast pace for 2 minutes) 7. Standing balance 8. Sit-to-stand test 9. Timed-up-and-go test 10. Cognitive function tests (such as memory and attention tests completed on a touchscreen computer) 11. Psycho-social wellbeing tests (completed on a computer).
Change from baseline life satisfaction at 2 months0 and 2 monthsThe satisfaction with life scale will be used
Change from baseline quality of life at 2 months0 and 2 monthsThe World Health Organization Quality of Life scale (WHOQoL-BREF) will be used
Change from baseline meaning and purpose at 2 months0 and 2 monthsThe National Institutes of health toolbox meaning and purpose test will be used
Change from baseline social companionship at 2 months0 and 2 monthsThe companionship scale of the Patient-Reported Outcomes Measurement Information System (PROMIS) will be used
Change from baseline emotional support at 2 months0 and 2 monthsThe Patient-Reported Outcomes Measurement Information System (PROMIS) emotional support scale will be used
Change from baseline social functioning at 2 months0 and 2 monthsThe Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction with social roles scale will be used
Acceptability, feasibility and compliance with the healthy ageing phenotype (HAP) battery assessment procedures2 monthsParticipants will complete a questionnaire directed to evaluate the acceptability, feasibility and compliance with the healthy ageing phenotype (HAP) battery assessment procedures
Change from baseline positive affect at 2 months0 and 2 monthsThe National Institutes of Health toolbox positive affect scale will be used
Change from baseline instrumental support at 2 months0 and 2 monthsThe National Institutes of Health toolbox instrumental support scale will be used
Change from baseline satisfaction with social roles and activities at 2 months0 and 2 monthsThe National Institutes of Health toolbox satisfaction with social roles and activities scale will be used.
Change from baseline social isolation at 2 months0 and 2 monthsThe National Institutes of Health toolbox social isolation scale will be used
Change from baseline depression scale at 2 months0 and 2 monthsThe Center for Epidemiologic Studies Depression Scale (CES-D) will be used
Change from baseline processing speed at 2 months0 and 2 monthsThe letter digit substitution test will be used

Countries

United Kingdom

Contacts

Primary ContactJohn C Mathers, PhD
john.mathers@ncl.ac.uk+44 (0) 1912081133
Backup ContactJose Lara, PhD
jose.lara@newcastle.ac.uk+44 (0)191 2081141

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026