Aims of the study
Feasibility study
To assess the feasibility and acceptability of the FRESH recruitment strategy, intervention (including intervention fidelity), and accompanying outcome evaluation and;
to explore how FRESH could be optimised through a mixed-methods process evaluation.
Pilot study
To assess the feasibility and acceptability of the revised recruitment strategy, long-term retention, FRESH intervention and outcome evaluation (after feasibility testing) and;
to explore further intervention optimisation and preliminary effectiveness.
Design
Feasibility study
A 6-week two-armed, parallel-group, randomised feasibility study, using a 1:1 allocation ratio, aiming to recruit 20 families with an index child aged 8-10 years. Following baseline assessment, families were randomly allocated to one of two intervention arms. In the child only arm, the index child was the focus of the intervention, with family members simply providing support. In contrast, in the family arm all participating family members received the FRESH intervention. Families in both arms received pedometers and access to the intervention website, enabling participants to select step challenges, log steps, and track progress as they virtually ‘walk’ around the world.
Pilot study
FRESH was an 8-week three-armed, parallel-group, randomised controlled pilot trial, using a 1:1:1 allocation ratio and long-term follow-up (52 weeks post-baseline). Following baseline assessment, families were randomly allocated to one of three arms: (1) FRESH arm, (2) pedometer-only arm, or (3) no-intervention control arm. All family members in the pedometer-only and FRESH arms received pedometers and generic family physical activity promotion information. FRESH families additionally received access to the intervention website, enabling participants to select step challenges, log steps, and track progress as they virtually globetrot. Control families were asked to carry on as normal.
Chief/Principal investigator
Dr Esther van Sluijs – University of Cambridge
Co-Investigators
Dr Helen Brown – The Behavioural Insights Team (previously University of Cambridge)
Dr Emma Coombes – University of East Anglia
Dr Justin Guagliano – University of Cambridge
Professor Claire Hughes – University of Cambridge
Dr Andy Jones – University of East Anglia
Dr Katie Morton – Innovia Technology (previously University of Cambridge)
Status
Completed.
Unit role
Unit led study with responsibility for data.
Sponsors
The study is sponsored by the University of Cambridge.
Partners and Stakeholders
Active Norfolk
Suffolk County Council
Funding
This work was supported by the National Institute for Health Research Public Health Research Programme (project number 15/01/19). Intervention costs for the current study were supported by Active Norfolk and Suffolk County Council. Funding was also received from the Medical Research Council (project number MC_UU_12015/7).
This work was undertaken by the Centre for Diet and Activity Research (CEDAR), where funding from Cancer Research UK, the British Heart Foundation, the Economic and Social Research Council, the Medical Research Council, the National Institute for Health Research, and the Wellcome Trust, under the auspices of the UK Clinical Research Collaboration, is gratefully acknowledged [087636/Z/08/Z; ES/G007462/1; MR/K023187/1].
Data sharing
Data can be made available upon request, for more information please see our Data Sharing pages.
Trial Registration Number
This study was prospectively registered (ISRCTN12789422). Registered 16 March 2016. http://www.isrctn.com/ISRCTN12789422
