Lifestyle Interventions at Retirement

Health Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02136381
• Other study ID #: LiveWell_00745/2014
• Status: Recruiting
• Phase: N/A
• First received: April 28, 2014
• Last updated: May 8, 2014
• Start date: May 2014
• Est. completion date: February 2015

Study information

• Verified date: May 2014
• Source: Newcastle University
• Contact: John C Mathers, PhD
• Phone: +44 (0) 1912081133
• Email: john.mathers[@]ncl.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 70 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Health Behavior

Intervention

Behavioral:
• LEAP 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
• Control
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.

Locations

Country	Name	City	State
United Kingdom	Human Nutrition Research Centre, Institute for Ageing and Health, Newcastle University	Newcastle upon Tyne	Tyne and Wear

Sponsors (1)

Lead Sponsor	Collaborator
Newcastle University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and acceptability of intervention	Participants will complete a questionnaire directed to obtain early markers of how the intervention is used	2 months	No
Secondary	Functional outcomes	At 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: Resting blood pressure; 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); Dexterity test (measuring the ability to coordinate fingers to manipulate objects quickly and accurately); Handgrip strength (a measure of muscle strength); Walking speed (measured by walking 4 meters at a normal pace); Endurance (measured by walking at a fast pace for 2 minutes); Standing balance; Sit-to-stand test; Timed-up-and-go test; Cognitive function tests (such as memory and attention tests completed on a touchscreen computer); Psycho-social wellbeing tests (completed on a computer).	At 0 and 2 months	No
Secondary	Change from baseline physical activity levels at 2 months	Physical activity will be assessed assessed during seven days at baseline and after 2 months interventions by accelerometry.	0 and 2 months	No
Secondary	Change from baseline dietary intake	Participants 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.	0 and 2 months	No
Secondary	Change from baseline resting blood pressure at 2 months		0 and 2 months	No
Secondary	Change from baseline lung function at 2 months	Lung 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)	0 and 2 months	No
Secondary	Change from baseline dexterity at 2 months	The 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.	0 and 2 months	No
Secondary	Change from baseline Handgrip strength at 2 months		0 and 2 months	No
Secondary	Change from baseline walking speed at 2 months	Walking speed will be measured by walking 4 meters at a normal pace	0 and 2 months	No
Secondary	Change from baseline endurance at 2 months	Endurance will be measured as the total distance walked at a fast pace during 2 minutes	0 and 2 months	No
Secondary	Change from baseline standing balance at 2 months		0 and 2 months	No
Secondary	Change from baseline functional change of transitional movements at 2 months	The sit-to-stand test will be used	0 and 2 months	No
Secondary	Change from baseline mobility at 2 months	The timed-up-and-go test will be used	0 and 2 months	No
Secondary	Change from baseline episodic memory at 2 months	The Paired Associates Learning (PAL) episodic memory test will be used	0 and 2 months	No
Secondary	Change from baseline verbal and category fluency at 2 months	The verbal and category fluency test will be used	0 and 2 months	No
Secondary	Change from baseline processing speed at 2 months	The letter digit substitution test will be used	0 and 2 months	No
Secondary	Change from baseline life satisfaction at 2 months	The satisfaction with life scale will be used	0 and 2 months	No
Secondary	Change from baseline quality of life at 2 months	The World Health Organization Quality of Life scale (WHOQoL-BREF) will be used	0 and 2 months	No
Secondary	Change from baseline meaning and purpose at 2 months	The National Institutes of health toolbox meaning and purpose test will be used	0 and 2 months	No
Secondary	Change from baseline social companionship at 2 months	The companionship scale of the Patient-Reported Outcomes Measurement Information System (PROMIS) will be used	0 and 2 months	No
Secondary	Change from baseline emotional support at 2 months	The Patient-Reported Outcomes Measurement Information System (PROMIS) emotional support scale will be used	0 and 2 months	No
Secondary	Change from baseline social functioning at 2 months	The Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction with social roles scale will be used	0 and 2 months	No
Secondary	Acceptability, feasibility and compliance with the healthy ageing phenotype (HAP) battery assessment procedures	Participants will complete a questionnaire directed to evaluate the acceptability, feasibility and compliance with the healthy ageing phenotype (HAP) battery assessment procedures	2 months	No
Secondary	Change from baseline positive affect at 2 months	The National Institutes of Health toolbox "positive affect scale" will be used	0 and 2 months	No
Secondary	Change from baseline instrumental support at 2 months	The National Institutes of Health toolbox "instrumental support" scale will be used	0 and 2 months	No
Secondary	Change from baseline satisfaction with social roles and activities at 2 months	The National Institutes of Health toolbox "satisfaction with social roles and activities" scale will be used.	0 and 2 months	No
Secondary	Change from baseline social isolation at 2 months	The National Institutes of Health toolbox "social isolation" scale will be used	0 and 2 months	No
Secondary	Change from baseline depression scale at 2 months	The Center for Epidemiologic Studies Depression Scale (CES-D) will be used	0 and 2 months	No

External Links

•   More information about the LiveWell research programme