Clinical trial NCT02136381: Lifestyle Interventions at Retirement
Official title: Pilot Randomised Controlled Trial of an Internet-based Lifestyle Intervention for People Around Retirement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Behavior
Keywords: Lifestyle, interventions, retirement
Lead sponsor: Newcastle University
Sponsor class: OTHER
First posted: 2014-05-13
Enrollment: 90
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Feasibility and acceptability of intervention
timeFrame: 2 months
Secondary outcomes:
measure: Functional outcomes
timeFrame: At 0 and 2 months
measure: Change from baseline physical activity levels at 2 months
timeFrame: 0 and 2 months
measure: Change from baseline dietary intake
timeFrame: 0 and 2 months
measure: Change from baseline resting blood pressure at 2 months
timeFrame: 0 and 2 months
measure: Change from baseline lung function at 2 months
timeFrame: 0 and 2 months
measure: Change from baseline dexterity at 2 months
timeFrame: 0 and 2 months
measure: Change from baseline Handgrip strength at 2 months
timeFrame: 0 and 2 months
measure: Change from baseline walking speed at 2 months
timeFrame: 0 and 2 months
measure: Change from baseline endurance at 2 months
timeFrame: 0 and 2 months
measure: Change from baseline standing balance at 2 months
timeFrame: 0 and 2 months
measure: Change from baseline functional change of transitional movements at 2 months
timeFrame: 0 and 2 months
measure: Change from baseline mobility at 2 months
timeFrame: 0 and 2 months
measure: Change from baseline episodic memory at 2 months
timeFrame: 0 and 2 months
measure: Change from baseline verbal and category fluency at 2 months
timeFrame: 0 and 2 months
measure: Change from baseline processing speed at 2 months
timeFrame: 0 and 2 months
measure: Change from baseline life satisfaction at 2 months
timeFrame: 0 and 2 months
measure: Change from baseline quality of life at 2 months
timeFrame: 0 and 2 months
measure: Change from baseline meaning and purpose at 2 months
timeFrame: 0 and 2 months
measure: Change from baseline social companionship at 2 months
timeFrame: 0 and 2 months
measure: Change from baseline emotional support at 2 months
timeFrame: 0 and 2 months
measure: Change from baseline social functioning at 2 months
timeFrame: 0 and 2 months
measure: Acceptability, feasibility and compliance with the healthy ageing phenotype (HAP) battery assessment procedures
timeFrame: 2 months
measure: Change from baseline positive affect at 2 months
timeFrame: 0 and 2 months
measure: Change from baseline instrumental support at 2 months
timeFrame: 0 and 2 months
measure: Change from baseline satisfaction with social roles and activities at 2 months
timeFrame: 0 and 2 months
measure: Change from baseline social isolation at 2 months
timeFrame: 0 and 2 months
measure: Change from baseline depression scale at 2 months
timeFrame: 0 and 2 months
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Human Nutrition Research Centre, Institute for Ageing and Health, Newcastle University
state: Tyne and Wear
Study officials:
affiliation: Human Nutrition Research Centre, Institute for Ageing and Health, Newcastle University
name: John C Mathers, PhD
role: STUDY_DIRECTOR
affiliation: Institute for Health and Society, Newcastle University
name: Martin White, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute for Health and Society, Newcastle University
name: Falko F Sniehotta, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Newcastle University
name: Lynn Rochester, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Newcastle University
name: Moynihan J Paula, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Neuroscience, Newcastle University
name: Thomas D Meyer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lara J, O'Brien N, Godfrey A, Heaven B, Evans EH, Lloyd S, Moffatt S, Moynihan PJ, Meyer TD, Rochester L, Sniehotta FF, White M, Mathers JC. Pilot Randomised Controlled Trial of a Web-Based Intervention to Promote Healthy Eating, Physical Activity and Meaningful Social Connections Compared with Usual Care Control in People of Retirement Age Recruited from Workplaces. PLoS One. 2016 Jul 29;11(7):e0159703. doi: 10.1371/journal.pone.0159703. eCollection 2016.