Pilot Randomised Controlled Trial of an Internet-based Lifestyle Intervention for People Around Retirement
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Health Behavior
- Sponsor
- Newcastle University
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Feasibility and acceptability of intervention
- Last Updated
- 11 years ago
Overview
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.
Investigators
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)
Outcomes
Primary Outcomes
Feasibility and acceptability of intervention
Time Frame: 2 months
Participants will complete a questionnaire directed to obtain early markers of how the intervention is used
Secondary Outcomes
- Change from baseline episodic memory at 2 months(0 and 2 months)
- Functional outcomes(At 0 and 2 months)
- Change from baseline physical activity levels at 2 months(0 and 2 months)
- Change from baseline dietary intake(0 and 2 months)
- Change from baseline resting blood pressure at 2 months(0 and 2 months)
- Change from baseline lung function at 2 months(0 and 2 months)
- Change from baseline dexterity at 2 months(0 and 2 months)
- Change from baseline Handgrip strength at 2 months(0 and 2 months)
- Change from baseline walking speed at 2 months(0 and 2 months)
- Change from baseline endurance at 2 months(0 and 2 months)
- Change from baseline standing balance at 2 months(0 and 2 months)
- Change from baseline functional change of transitional movements at 2 months(0 and 2 months)
- Change from baseline mobility at 2 months(0 and 2 months)
- Change from baseline verbal and category fluency at 2 months(0 and 2 months)
- Change from baseline satisfaction with social roles and activities at 2 months(0 and 2 months)
- Change from baseline social isolation at 2 months(0 and 2 months)
- Change from baseline depression scale at 2 months(0 and 2 months)
- Change from baseline processing speed at 2 months(0 and 2 months)
- Change from baseline life satisfaction at 2 months(0 and 2 months)
- Change from baseline quality of life at 2 months(0 and 2 months)
- Change from baseline meaning and purpose at 2 months(0 and 2 months)
- Change from baseline social companionship at 2 months(0 and 2 months)
- Change from baseline emotional support at 2 months(0 and 2 months)
- Change from baseline social functioning at 2 months(0 and 2 months)
- Acceptability, feasibility and compliance with the healthy ageing phenotype (HAP) battery assessment procedures(2 months)
- Change from baseline positive affect at 2 months(0 and 2 months)
- Change from baseline instrumental support at 2 months(0 and 2 months)