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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
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
PLoS ONE 2016 Jul;11(7):e0159703
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: No; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Lifestyle interventions delivered during the retirement transition might promote healthier ageing. We report a pilot randomised controlled trial (RCT) of a web-based platform (Living, Eating, Activity and Planning through retirement; LEAP) promoting healthy eating (based on a Mediterranean diet (MD)), physical activity (PA) and meaningful social roles. METHODS: A single blinded, two-arm RCT with individual allocation. Seventy-five adult regular internet users living in Northeast England, within two years of retirement, were recruited via employers and randomised in a 2:1 ratio to receive LEAP or a 'usual care' control. Intervention arm participants were provided with a pedometer to encourage self-monitoring of PA goals. Feasibility of the trial design and procedures was established by estimating recruitment and retention rates, and of LEAP from usage data. At baseline and 8-week follow-up, adherence to a MD derived from three 24-hour dietary recalls and seven-day PA by accelerometry were assessed. Healthy ageing outcomes (including measures of physiological function, physical capability, cognition, psychological and social wellbeing) were assessed and acceptability established by compliance with measurement protocols and completion rates. Thematically analysed, semi-structured, qualitative interviews assessed acceptability of the intervention, trial design, procedures and outcome measures. RESULTS: Seventy participants completed the trial; 48 (96%) participants in the intervention and 22 (88%) in the control arm. Participants had considerable scope for improvement in diet as assessed by MD score. LEAP was visited a median of 11 times (range 1 to 80) for a mean total time of 2.5 hours (range 5.5 min to 8.3 hours). 'Moving more', 'eating well' and 'being social' were the most visited modules. At interview, participants reported that diet and PA modules were important and acceptable within the context of healthy ageing. Participants found both trial procedures and outcome assessments acceptable. CONCLUSIONS: The trial procedures and the LEAP intervention proved feasible and acceptable. Effectiveness and cost-effectiveness of LEAP to promote healthy lifestyles warrant evaluation in a definitive RCT. TRIAL REGISTRATION: ClinicalTrials.gov NCT02136381.

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