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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in Self-efficacy over 6 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Living alone
- •Aged over 60
- •Screen positive for Social Isolation (Lubben & Gironda, 2004).
排除标准
- •Screen positive for cognitive impairment using the TCogS (Telephone Cognitive Screen; Newkirk et al., 2004).
- •Schizophrenia
- •Bipolar affective disorder
- •Recurrent psychotic depression
- •Alcohol and drug abuse within the past 5 years
- •Anti-convulsants
- •Anti-psychotic medications
- •Significant hearing difficulties even when wearing hearing aid
- •Illness that caused permanent decrease in memory or other mental function
- •Blood borne infectious diseases
- •Contact based infectious diseases
- •Airborne infectious diseases
- •Peer Volunteers
- •Inclusion Criteria:
- •Provision of two character references
- •Aged over 55
- •Undergoes Garda (police) vetting to the satisfaction of the research team
- •Exclusion Criteria:
- •Screen positive for cognitive impairment using the TCogS (Newkirk et al., 2004)
结局指标
主要结局
Change in Self-efficacy over 6 months
时间窗: Assessed at baseline, in the week post-intervention, at 12-week and at 26-week follow-up
Self-efficacy measured using the Generalised Self-efficacy scale (Schwarzer \& Jerusalem,1995) and the nutrition self-efficacy scale (Schwarzer \& Renner, 2000) will be assessed for all participants.
Change in Food-related health beliefs over 6 months
时间窗: At baseline, in the week post-intervention, at 12-week and 26-week follow-up
This outcome measure is a social cognitive variable measured using the Health Beliefs Survey (Anderson, Winett \& Wojcik, 2007). The survey assess beliefs related to the impact of food on health, including food-related goals, outcome expectations, beliefs and strategies relating to food.
Change in Energy intake over 6 months
时间窗: Baseline, in the week post-intervention, at 12-week and 26-week follow-up
Energy intake will be measured using two 24-hour dietary recall metrics, whereby the participant is asked to recall on two occasions within the same week everything they have eaten or drank in the past 24 hours. The assessors will receive dietetic training in how to measure energy intake, e.g. the types of probes and questions that can help to achieve an accurate recall of dietary intake.
次要结局
- Change in Quality of Life over 6 months(Baseline, in the week post-intervention, at 12-week and 26-week follow-up)
- Change in Cognitive function over 6 months(Baseline, in the week post-intervention, and at 12-week and 26-week follow-up)
- Premorbid cognitive function(Baseline assessment)
- Change in Social Connectedness over 6 months(Baseline assessment, in the week post-intervention, and at 12-week and 26-week follow-up)
- Change in Psychological Wellbeing over 6 months(Baseline assessment, in the week post-intervention, at 12-week and 26-week follow-up)
- Change in Nutritional Health over 6 months(Baseline assessment, in the week post-intervention, 12-week and 26-week follow-up)
- Change in Body Mass Index over 6 months(Baseline assessment, in the week post-intervention and at 12-week and 26-week follow-up)
- Change in Frailty over 6 months(Baseline assessment, in the week post-intervention, and at 12-week and 26-week follow-up)
- Change in Overall Health over 6 months(Baseline assessment, in the week post-intervention, 12-week and 26-week follow-up)
- Change in Peer volunteer wellbeing pre and post intervention(Baseline and in the week post-intervention)
研究者
Joanna McHugh
Postdoctoral Research Fellow
University of Dublin, Trinity College