Lifestyle Interventions at Retirement

NCT02136381 | Unknown

• 1 other identifier: LiveWell_00745/2014
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Behavior

Keywords

Lifestyle, interventions, retirement

Outcome Measures

Primary Outcomes (1)

• Feasibility and acceptability of intervention

  Participants will complete a questionnaire directed to obtain early markers of how the intervention is used

  2 months

Secondary Outcomes (27)

• 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

Study Arms (2)

LEAP intervention

EXPERIMENTAL

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

Control

OTHER

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

Interventions

LEAP intervention BEHAVIORAL

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

LEAP intervention

Control BEHAVIORAL

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.

Control

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults within 2 years (before/after) retirement from full time work
• Healthy volunteers
• Internet users
• English language speakers

You may not qualify if:

• Non-internet users
• Non-English speakers
• Not within the peri-retirement period (within two years of retirement)

Sponsors & Collaborators

• Newcastle University: lead

Study Sites (1)

Human Nutrition Research Centre, Institute for Ageing and Health, Newcastle University

Newcastle upon Tyne, Tyne and Wear, NE45PL, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 27472560 DERIVED

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• John C Mathers, PhD

  Human Nutrition Research Centre, Institute for Ageing and Health, Newcastle University

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John C Mathers, PhD

CONTACT

+44 (0) 1912081133; john.mathers@ncl.ac.uk

Jose Lara, PhD

CONTACT

+44 (0)191 2081141; jose.lara@newcastle.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: May 13, 2014
• Study Start: May 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: May 13, 2014

Record last verified: 2014-05

Locations

GB (1)