Lifestyle Interventions at Retirement

Health Behavior Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Health Behavior

• NCT number: NCT02136381
• Study type: Interventional
• Source: Newcastle University
• Contact: John C Mathers, PhD
• Phone: +44 (0) 1912081133
• Email: john.mathers@ncl.ac.uk
• Status: Recruiting
• Phase: N/A
• Start date: May 2014
• Completion date: February 2015