Social Isolation Clinical Trial
Official title:
RelAte: An Investigator-blinded, Randomised, 8-week, Parallel-group, Controlled Stepped Wedge Design Study to Evaluate the Effectiveness of a Complex Nutritional, Cooking and Social Intervention Against a Control Group in the Improvement of Dietary Self-efficacy and Energy Intake Among Older Adults Living Alone.
The purpose of this study is to evaluate the impact of a psychosocial and nutritional intervention, entitled "RelAte", on cooking and mealtime behaviours of older adults who are living alone and at risk of social isolation. The intervention will be delivered in the home of participants by a trained volunteer of a similar age.
The trial employs a randomised controlled trial design to evaluate the impact of a novel
mealtime intervention for older adults who are living alone and may be at risk of social
isolation. The intervention combines social interaction, cooking, and shared mealtime
behaviour, as well as nutritional education, in a once-weekly, mealtime visit, delivered by
a peer volunteer. RelAte is grounded in psychological theory. It is expected that the RelAte
intervention will have a beneficial impact on self-efficacy and on energy intake among
participants. As an additional point, we will be looking at whether the intervention also
impacts on physical and mental health among older adults over time. RelAte involves sharing
a mealtime with a trained peer volunteer once a week for 8 weeks, as well as sharing the
cooking and food preparation associated with the meal. The one-to-one intervention comprises
social, nutritional and cooking components, and can be described as a complex intervention.
The intervention will run for 8 weeks and each participant will be matched with a peer
volunteer for the duration. At baseline and at three follow-up points, participants will
undergo a social cognitive, and nutritional assessment, as well as physical and mental
health assessments, to ascertain whether the intervention has a lasting impact on defined
primary outcomes. Participant outcomes will also be compared with the control group to
assess the impact of the intervention. Volunteers will also undergo an assessment to
investigate whether being a volunteer in an intervention has positive impact on
psychological wellbeing and social connectedness.
Primarily the intention is to improve self-efficacy and energy intake among older adults,
thus maintaining or improving general functioning, rather than treating an existing
condition or syndrome. Thus the intervention aims to optimise functioning in older adults
rather than to treat a pre-existing condition.
;
Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
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