Evaluating the RelAte Mealtime Program as an Intervention to Treat Social Isolation and Improve Cooking Behaviour Among Older Adults Living Alone

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Social Isolation, Meals

Intervention / Treatment
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* Behavioral: Mealtime Intervention


Participation Criteria
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Eligibility Criteria
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Participants Inclusion Criteria: Living alone Aged over 60 Screen positive for Social Isolation (Lubben & Gironda, 2004). Exclusion Criteria: Screen positive for cognitive impairment using the TCogS (Telephone Cognitive Screen; Newkirk et al., 2004). Stroke Epilepsy 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)

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mealtime Intervention<br>The mealtime intervention group will receive a trained peer volunteer to their home once weekly for 8 weeks to prepare and share a meal with them. | Behavioral: Mealtime Intervention<br>* The mealtime intervention constitutes once a week visits from a trained volunteer for 8 weeks, each visit lasting 90 minutes and comprising of preparing and sharing a meal together with the participant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Self-efficacy over 6 months | 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. | Assessed at baseline, in the week post-intervention, at 12-week and at 26-week follow-up | 
| Change in Food-related health beliefs over 6 months | 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. | At baseline, in the week post-intervention, at 12-week and 26-week follow-up | 
| Change in Energy intake over 6 months | 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. | Baseline, in the week post-intervention, at 12-week and 26-week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life over 6 months | Participant quality of life, measured using the CASP-19 (Control, Autonomy, Self-Realisation, Pleasure) Measure (Hyde, Wiggins, Higgs & Blane, 2003) will be used as a secondary measure to evaluate whether RelAte intervention improves quality of life over time. | Baseline, in the week post-intervention, at 12-week and 26-week follow-up | 
| Change in Cognitive function over 6 months | Cognitive function in the participants will be assessed over time using 2 measures: the Montreal Cognitive Assessment (Nasreddine et al., 2005) and the Trail Making Test (Lezak, 2004). | Baseline, in the week post-intervention, and at 12-week and 26-week follow-up | 
| Premorbid cognitive function | Premorbid cognitive function will be assessed using the National Adult Reading test (Bright, Jaldow & Kopelman, 2002). | Baseline assessment | 
| Change in Social Connectedness over 6 months | Social connectedness will be measured using the Berkman Social Network Index (Berkman & Syme, 1979). | Baseline assessment, in the week post-intervention, and at 12-week and 26-week follow-up | 
| Change in Psychological Wellbeing over 6 months | Psychological wellbeing in participants will be assessed using the Centre for Epidemiological Studies depression scale (CES-D; Radloff,1977), the Hospital Anxiety & Depression - Anxiety Subscale (HADS-A; Zigmond & Snaith, 1983) and the Ryff scale of psychological wellbeing (Ryff & Keyes,1995). | Baseline assessment, in the week post-intervention, at 12-week and 26-week follow-up | 
| Change in Nutritional Health over 6 months | Nutritional health and risk of malnutrition will be assessed using the Mini Nutritional Assessment (Vellas et al.,1999) the Malnutrition Universal Screening Tool (Stratton, 2004). as well as the Food Enjoyment Scale (Vailas & Nitzke, 1998). | Baseline assessment, in the week post-intervention, 12-week and 26-week follow-up | 
| Change in Body Mass Index over 6 months | Body mass index for each participant will be measured using a clinical stadiometer and body composition weighing scales. Abdominal circumference will also be measured to further assess body composition. | Baseline assessment, in the week post-intervention and at 12-week and 26-week follow-up | 
| Change in Frailty over 6 months | Frailty will be measured using the SHARE-Frailty Instrument (Romero-Ortuno, Walsh, Lawlor & Kenny, 2010) which includes measurement of grip strength using a clinical dynamometer. | Baseline assessment, in the week post-intervention, and at 12-week and 26-week follow-up | 
| Change in Overall Health over 6 months | Overall health will be assessed using the Health Utilities Index (Horsman, Furlong, Feeny & Torrance, 2003). | Baseline assessment, in the week post-intervention, 12-week and 26-week follow-up | 
| Change in Peer volunteer wellbeing pre and post intervention | We will also assess the wellbeing of the peer volunteers trained to deliver the intervention, measured using the Ryff scale (Ryff & Keyes,1995). T the Minnesota Satisfaction Questionnaire (Weiss, Dawis & England, 1967), the de Jong loneliness scale (De Jong Gierveld & Van Tilburg, 2006) and the Social Network Index (Berkman & Syme,1979). | Baseline and in the week post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food Habits, Social Isolation, Nutrition Assessments, Meals, Self Efficacy, Quality of Life, Peer Group