Trial record 5 of 39 for:    LEAP

Lifestyle Interventions at Retirement

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Newcastle University
Sponsor:
Information provided by (Responsible Party):
Newcastle University
ClinicalTrials.gov Identifier:
NCT02136381
First received: April 28, 2014
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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.

Condition Intervention
Health Behavior
Behavioral: LEAP intervention
Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Pilot Randomised Controlled Trial of an Internet-based Lifestyle Intervention for People Around Retirement

Further study details as provided by Newcastle University:

Primary Outcome Measures:
  • Feasibility and acceptability of intervention [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Participants will complete a questionnaire directed to obtain early markers of how the intervention is used


Secondary Outcome Measures:
  • Functional outcomes [ Time Frame: At 0 and 2 months ] [ Designated as safety issue: No ]

    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:

    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 physical activity levels at 2 months [ Time Frame: 0 and 2 months ] [ Designated as safety issue: No ]
    Physical activity will be assessed assessed during seven days at baseline and after 2 months interventions by accelerometry.

  • Change from baseline dietary intake [ Time Frame: 0 and 2 months ] [ Designated as safety issue: No ]
    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.

  • Change from baseline resting blood pressure at 2 months [ Time Frame: 0 and 2 months ] [ Designated as safety issue: No ]
  • Change from baseline lung function at 2 months [ Time Frame: 0 and 2 months ] [ Designated as safety issue: No ]
    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)

  • Change from baseline dexterity at 2 months [ Time Frame: 0 and 2 months ] [ Designated as safety issue: No ]
    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.

  • Change from baseline Handgrip strength at 2 months [ Time Frame: 0 and 2 months ] [ Designated as safety issue: No ]
  • Change from baseline walking speed at 2 months [ Time Frame: 0 and 2 months ] [ Designated as safety issue: No ]
    Walking speed will be measured by walking 4 meters at a normal pace

  • Change from baseline endurance at 2 months [ Time Frame: 0 and 2 months ] [ Designated as safety issue: No ]
    Endurance will be measured as the total distance walked at a fast pace during 2 minutes

  • Change from baseline standing balance at 2 months [ Time Frame: 0 and 2 months ] [ Designated as safety issue: No ]
  • Change from baseline functional change of transitional movements at 2 months [ Time Frame: 0 and 2 months ] [ Designated as safety issue: No ]
    The sit-to-stand test will be used

  • Change from baseline mobility at 2 months [ Time Frame: 0 and 2 months ] [ Designated as safety issue: No ]
    The timed-up-and-go test will be used

  • Change from baseline episodic memory at 2 months [ Time Frame: 0 and 2 months ] [ Designated as safety issue: No ]
    The Paired Associates Learning (PAL) episodic memory test will be used

  • Change from baseline verbal and category fluency at 2 months [ Time Frame: 0 and 2 months ] [ Designated as safety issue: No ]
    The verbal and category fluency test will be used

  • Change from baseline processing speed at 2 months [ Time Frame: 0 and 2 months ] [ Designated as safety issue: No ]
    The letter digit substitution test will be used

  • Change from baseline life satisfaction at 2 months [ Time Frame: 0 and 2 months ] [ Designated as safety issue: No ]
    The satisfaction with life scale will be used

  • Change from baseline quality of life at 2 months [ Time Frame: 0 and 2 months ] [ Designated as safety issue: No ]
    The World Health Organization Quality of Life scale (WHOQoL-BREF) will be used

  • Change from baseline meaning and purpose at 2 months [ Time Frame: 0 and 2 months ] [ Designated as safety issue: No ]
    The National Institutes of health toolbox meaning and purpose test will be used

  • Change from baseline social companionship at 2 months [ Time Frame: 0 and 2 months ] [ Designated as safety issue: No ]
    The companionship scale of the Patient-Reported Outcomes Measurement Information System (PROMIS) will be used

  • Change from baseline emotional support at 2 months [ Time Frame: 0 and 2 months ] [ Designated as safety issue: No ]
    The Patient-Reported Outcomes Measurement Information System (PROMIS) emotional support scale will be used

  • Change from baseline social functioning at 2 months [ Time Frame: 0 and 2 months ] [ Designated as safety issue: No ]
    The 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 procedures [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Participants 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 months [ Time Frame: 0 and 2 months ] [ Designated as safety issue: No ]
    The National Institutes of Health toolbox "positive affect scale" will be used

  • Change from baseline instrumental support at 2 months [ Time Frame: 0 and 2 months ] [ Designated as safety issue: No ]
    The National Institutes of Health toolbox "instrumental support" scale will be used

  • Change from baseline satisfaction with social roles and activities at 2 months [ Time Frame: 0 and 2 months ] [ Designated as safety issue: No ]
    The National Institutes of Health toolbox "satisfaction with social roles and activities" scale will be used.

  • Change from baseline social isolation at 2 months [ Time Frame: 0 and 2 months ] [ Designated as safety issue: No ]
    The National Institutes of Health toolbox "social isolation" scale will be used

  • Change from baseline depression scale at 2 months [ Time Frame: 0 and 2 months ] [ Designated as safety issue: No ]
    The Center for Epidemiologic Studies Depression Scale (CES-D) will be used


Estimated Enrollment: 90
Study Start Date: May 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LEAP intervention
A newly developed internet-based lifestyle programme (Living, Eating, Activity and Planning through retirement (LEAP)) will promote three key health and social behaviours; healthy eating following a Mediterranean diet, increasing physical activity and improve social connectedness.
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).

This website contains general information on improving life style and health.

Behavioral: 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.


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

Ages Eligible for Study:   55 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02136381

Contacts
Contact: John C Mathers, PhD +44 (0) 1912081133 john.mathers@ncl.ac.uk
Contact: Jose Lara, PhD +44 (0)191 2081141 jose.lara@newcastle.ac.uk

Locations
United Kingdom
Human Nutrition Research Centre, Institute for Ageing and Health, Newcastle University Recruiting
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE45PL
Contact: John C Mathers, PhD    +44 (0) 1912081133    john.mathers@ncl.ac.uk   
Contact: Jose Lara, PhD    +44 (0) 1912081141    jose.lara@ncl.ac.uk   
Sponsors and Collaborators
Newcastle University
Investigators
Study Director: John C Mathers, PhD Human Nutrition Research Centre, Institute for Ageing and Health, Newcastle University
Principal Investigator: Martin White, PhD Institute for Health and Society, Newcastle University
Principal Investigator: Falko F Sniehotta, PhD Institute for Health and Society, Newcastle University
Principal Investigator: Lynn Rochester, PhD Newcastle University
Principal Investigator: Moynihan J Paula, PhD Newcastle University
Principal Investigator: Thomas D Meyer, PhD Institute of Neuroscience, Newcastle University
  More Information

Additional Information:
No publications provided

Responsible Party: Newcastle University
ClinicalTrials.gov Identifier: NCT02136381     History of Changes
Other Study ID Numbers: LiveWell_00745/2014
Study First Received: April 28, 2014
Last Updated: May 8, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Newcastle University:
Lifestyle, interventions, retirement

ClinicalTrials.gov processed this record on September 03, 2015